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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. We’re Grifols, a global healthcare company and international plasma manufacturer headquartered in Barcelona, Spain. We serve healthcare professionals and patients in over 110 countries, have an unmatched record of product safety, and are the largest plasmapheresis company in the world. Job Title: CENTER MANAGER Estimated Salary Range: $81,600.00 - $122,400.00 per year, depending on training, education, and experience. This position is eligible to participate in up to 30% of the company bonus pool. This position is eligible for a $10,000 Sign-on Bonus & Relocation Assistance of up to $20K! Summary: Acts as the general manager for a Plasma Collection Center and has overall responsibility for the center's operation. Works under general occasional guidance and general oversight of regional management. Manages the daily operations of the center, supervising operations and quality control, and ensuring compliance with all applicable policies and regulations. Primary Responsibilities for Role: • Responsible for meeting quarterly goals, staffing/hours per labor efficiency standards/cost per liter (CPL) targets and Quality key performance indicators (KPI) goals., • Create appropriate organizational environment and value systems which stimulate the morale and productivity of the work force and its leadership., • Operates the center and manages employees and operations to the highest standard of ethics and integrity., • Manages staff to ensure that training and quality goals are met and to implement operational changes and maximize center efficiency., • Directs and manages employees., • Monitor and evaluate operations. Develop action plans to maximize center efficiency and supervise the implementation of process improvements., • Manages headcount to provide for efficient staffing through high and low production intervals, providing accurate and timely projections to regional management team in advance of cyclical and seasonal or situational spikes., • Accountable for the direction of all personnel functions including hiring, assignment and direction of work, development and training, disciplinary actions and termination and the maintenance of all personnel records., • Provides strategic direction and planning. Other Responsibilities for Role: • Acts as a mentor to assigned team, other center staff and other centers., • Through Assistant Manager, oversees donor selection, plasma collection and shipment and records completion., • Accountable to ensure the adequate training of production employees and demonstrate how tasks are to be performed to meet company standards., • Accountable for the adequacy of inventory of all goods and supplies necessary for center operations and oversee ordering goods as needed., • Assure center employees maintain the facility in a neat and clean condition and all equipment is kept in good working order., • Accountable for freezer management, including overseeing plasma shipments and equipment failures. Required to answer all freezer alarms and deal with them appropriately., • Submit timely and accurate reports on a daily/weekly basis or as requested., • Develop community representation with regards to all public relations and marketing campaigns to attract and retain donors., • Maintains thorough familiarity and ensures compliance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP)., • Accountable for donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP)., • Directs through the management team and with Training and Quality staff to ensure that training and quality goals are met., • Builds rapport with donors to ensure overall customer satisfaction with the center to support long-term donation., • Works with Divisional/Corporate management in the preparation of annual budget and manages facility to consistently achieve production targets and quality goals at the agreed-upon cost structure., • Control center donor funds and ensure that all financial records are accurate and in order., • Identifies regulatory deficiencies and in collaboration with the Center Quality Manager implements immediate corrective action., • Minimize center liability through constant risk management review. Investigates all unsafe situations and complaints and institutes corrective/preventive action., • Establishes and maintains the ability to perform all tasks within the center; fulfills the role of production employees when the occasional need arises., • Assumes Regional management oversight and mentoring duties for select facilities/projects or in ROMs absence., • Performs other duties as required. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. Job Requirements: • Bachelor’s degree or equivalent, preferably in Science, Business, Nursing, Finance, or related field., • Typically requires a minimum of 3 years of related work experience in clinical or general business environment., • Supervisory experience preferred but not required., • Prior management experience, preferably supervising a group of 20 or more employees., • Experience in a medical and/or cGMP regulated environment preferred., • Experience with plasma or whole blood preferred. Equivalency: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an associate degree with 6 years of experience, or a master’s degree with 2 years of experience. Attributes: Command of leadership, management, presentation, organizational, customer service, interpersonal communication, and computer skills. Ability to understand, assess and communicate FDA regulations. Ability to balance multiple competing priorities, ensure proper staffing levels, maintain adequate levels of plasma collection, and adhere to quality standards. Ability to control costs and maintain a budget. Ability to motivate staff to achieve established goals and standards. Ability to develop positive relationships with donors, center employees, and company employees working in different geographical locations. Developing command of and proficiency in at least one functional area, such as finance, IT, HR, or compliance. Ability to relocate preferred. Compensation and Benefits: The estimated pay scale for the Center Manager position in Van Nuys, CA is $81,600.00 - $122,400.00 per year. Additionally, the position is eligible to participate in up to 30% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! “We are looking to grow our teams with people who share our energy and enthusiasm for creating the best experience for our donors/customers.” #BiomatUSA #CB #GrifolsJobs #Indeed #app #LI-Onsite Third Party Agency and Recruiter Notice: Agencies that present a candidate MUST have an active, nonexpired Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Location: NORTH AMERICA : USA : CA-Reseda Center Address: 19255 Vanowen St, Van Nuys, CA 91335 Contact: Alex S. Contreras, Senior Talent Acquisition Partner - (213) 219-5494 | acontreras@grifols.com _ • Follow us on Facebook: _, • Follow us on LinkedIn: _ To find more jobs with Grifols: _ Or Text GRIFOLS to 833-233-7621

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. As Lundbeck’s North American hub for early-stage drug discovery, the Lundbeck La Jolla Research Center positions our company to deliver transformative treatments for brain disease. Join us on our journey of discovery! Territory – West We will consider candidates who live within the territory boundaries with access to a major airport. Territory includes California, Nevada, Oregon, Washington, Idaho, Montana, and Wyoming. The exact state alignment and final territory will be determined based on candidate location and business need. SUMMARY: The Senior Medical Science Liaison (Sr MSL), Movement Disorders provides advanced, field-based medical and scientific leadership in support of Lundbeck’s NeuroRare focus on multiple system atrophy. This role serves as a strategic pre-launch scientific partner to external experts and internal stakeholders, generating high-quality, actionable insights that inform evidence strategy, disease education, portfolio decision-making, and launch readiness. The Sr MSL is expected to demonstrate outcome-oriented leadership, scientific depth, and insight generation that directly advances NeuroRare medical strategy, strengthens external scientific credibility, and shapes the disease environment. ESSENTIAL FUNCTIONS: Strategic Scientific Engagement & Insight Generation: • Establishes and sustains deep, longitudinal scientific partnerships with Key Opinion Leaders (KOLs), Centers of Excellence, and investigators working in multiple system atrophy., • Serves as a trusted scientific expert through high-quality, compliant scientific exchange that advances understanding of disease biology, unmet need, endpoints, and emerging evidence., • Acts as a primary generator of pre-launch actionable field medical insights by systematically testing scientific value narratives, differentiation hypotheses, and evidence gaps through external engagement., • Synthesizes and communicates high-quality insights with clear implications for evidence strategy, publication planning, disease education, and portfolio-level decision-making., • Ensures timely, accurate, and compliant documentation of insights in CRM systems in alignment with defined quality standards. Evidence Strategy & Cross-Functional Partnership: • Partners closely with Medical Directors, Clinical Development, Evidence Strategy, and other cross-functional teams to align field execution with enterprise scientific priorities., • Connects external experts internally to support advisory boards, evidence generation activities, publications, and strategic initiatives., • Identifies and facilitates investigator-initiated trials (IITs), grant submissions, and research collaborations aligned with NeuroRare medical strategy., • Supports clinical development activities, including investigator identification and site outreach, as appropriate and compliant. Disease Education & Scientific Credibility: • Delivers impactful, non-promotional disease education that advances recognition, diagnosis, and referral pathways across NeuroRare indications., • Ensures consistency, scientific rigor, and alignment of disease narratives and medical lexicon across field education activities., • Supports congress strategy execution by engaging in high-value scientific discussions, attending priority sessions, and facilitating strategic KOL interactions with Medical Leadership., • Maintains advanced knowledge of scientific and clinical developments in NeuroRare disease areas to inform education, insight generation, and evidence planning. Field Medical Excellence: • Demonstrates scientific and behavioral leadership through role modeling of best-in-class MSL execution, engagement quality, and compliance., • Actively contributes to Field Medical initiatives, workstreams, and process improvements that enhance scalability, quality, and impact., • Serves as a mentor and onboarding resource for new MSLs, as assigned, supporting development toward independent, high-quality field execution., • Completes all required training, administrative responsibilities, and documentation in accordance with Lundbeck policies and regulatory requirements on time., • Maintains full compliance with FDA, company, and governance standards with no critical findings. REQUIRED EDUCATION, EXPERIENCE, AND SKILLS: • Accredited advanced degree in a health or life sciences–related field., • ≥5 years of healthcare or related experience (industry, clinical practice, research, academic, or managed markets)., • ≥2 years of customer-facing Field Medical Affairs experience within a pharmaceutical, biotech, or life sciences organization., • Proven experience supporting pre-launch assets, including KOL identification, strategic mapping, trial site engagement., • Demonstrated ability to interpret complex scientific data and translate insights into meaningful scientific dialogue and decision-relevant insights., • Strong oral and written communication skills with the ability to influence without authority., • Proven ability to build trust, lead through scientific credibility, and operate effectively in a matrixed environment., • Track record of accountability, strategic thinking, and results orientation., • Driving is an essential duty of this job; must have a valid driver’s license in good standing., • The role is part of Lundbeck’s Vehicle Fleet Stipend Program and requires business use of a personal vehicle. More information on the stipend program can be found _ PREFERRED EDUCATION, EXPERIENCE, AND SKILLS: • Doctoral degree (MD, DO, PharmD, PhD), an accredited advanced clinical degree (NP or PA), or a master’s degree in a health sciences–related field., • Experience and relationships in rare disease, Parkinson’s disease, neurodegenerative disorders, ataxia, autonomic disorders, or other related disease areas., • Background in clinical practice, academic research, or teaching. Rare Disease Capabilities and Leadership: • Trusted and respected voice within the rare disease ecosystem, known for transparency, empathy, and meaningful community engagement., • Deep expertise in rare disease best practices., • Highly proactive and solutions-oriented, capable of driving organizational progress in ambiguous or unstructured settings., • Brings a mission-driven mindset — combining scientific rigor with empathy, credibility, and purpose to inspire cross-functional and external collaboration., • Maintains a broad and influential network within the rare disease ecosystem, effectively mobilizing partnerships and coalitions to accelerate shared goals. TRAVEL: • Field-based position with willingness and ability to travel up to 50–75% domestically. RemoteThe range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $180,000 - $220,000 and eligibility for a 20% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and Vehicle Fleet Stipend. Additional benefits information can be found on our _ Applications accepted on an ongoing basis. #LI-LM1, #LI-Remote We will consider for employment all qualified Applicants, including those with criminal histories (such as arrest or conviction records) in a manner consistent with the requirements of applicable state and local laws, including the California Fair Chance Act, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance, the Los Angeles County Fair Chance Ordinance for Employers, and the San Francisco Fair Chance Ordinance. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the _. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the _. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in _.

Job Title: Food Quality Specialists Job Location: Los Angeles-USA-90045 Work Location Type: On-Site Salary Range: $18.32 - 27.83 per hour Since 1942, SkyChefs has taken culinary excellence to new heights. As a trusted partner to the nation’s leading airlines and retailers, we proudly deliver millions of meals and exceptional service experiences every year across 43 sites throughout the United States. Built on a legacy of operational excellence, culinary expertise, and continuous innovation, we are committed to setting the industry standard in aviation culinary, airline services, last-mile logistics, and retail commerce. From the kitchen to the runway, our teams work together to deliver quality, reliability, and service at every altitude. Our people are the heart of everything we do. At Sky Chefs, a career is more than a job, it’s an opportunity to grow, lead, and make an impact in a fast-paced, team-driven environment. Join America’s first, foremost, and finest and take your career to new heights. As our Food Quality Specialist, you will play a key role in ensuring compliance with all major food safety and regulatory standards including FDA, USDA, HACCP, and our company’s Global Quality Standards (GQS). You’ll help us maintain a safe, clean, and audit‑ready environment while training and supporting our team to follow best practices. • Medical, Dental, and Vision coverage starting Day 1, • Employer‑paid life insurance and AD&D benefits, • 401(k) with company match, • Paid vacation, sick time, and holidays, • Tuition reimbursement, • Free meals and parking, • Career growth opportunities with a global organization, • Maintain and initiate all recordkeeping and key performance indicators pertinent to the Quality Department and GQS to include, but not limited to Food Safety, Sanitation, Regulatory Agencies (County Health, State Health Dept. and FDA), internal customers (LHI) and airline customers, • Daily monitor of Good Manufacturing Practices (GMPs) for compliance, • Verify of coolers and freezer room temperature for compliance, • Perform environmental swabs and microbiological sampling, submittal to local laboratory for analysis, • Obtain Chef Table samples to verify compliance to specification, • Assist the Quality Manager in specific training and daily initiatives addressing quality, food safety, and sanitation issues to drive process improvements, • Conduct work station inspections to verify compliance (gold standard verification, specs, sanitizer, food temperatures, HACCP documentation, phf set-up), • Conduct portion control weight compliance to specifications, • Conduct inspection checks (dispatch, galley, non-bonded, bonded, equipment), • Verify Hazard Analysis and Critical Control Points (HACCP) logs and other documents are accurately completed on a daily basis, • Create charts, trending reports, training materials and visuals, • Maintain, monitor standards and train employees in compliance to the Regulated Garbage Standards to meet USDA requirements, • Supports the Jump-off (commissary) locations with oversight, • Train hourly employees as needed, • Perform other tasks as requested, • Experience in food manufacturing, food safety, quality assurance, or regulatory compliance, • Strong knowledge of FDA, USDA, HACCP, sanitation standards, and food safety practices, • Confidence in delivering training, presentations, and cross‑functional communication, • Strong attention to detail and ability to lead or support audits and inspections, • A collaborative mindset with the ability to influence and support teams at all levels, • Ability to work in a fast‑paced environment while maintaining accuracy and professionalism SkyChefs is an EEO and Affirmative Action Employer of Women/Minorities/Veterans/Individuals with Disabilities.

Job Title: Food Quality Assurance Specialist Job Location: Los Angeles-USA-90045 Work Location Type: On-Site Salary Range: $18.32 - 27.83 per hour Since 1942, SkyChefs has taken culinary excellence to new heights. As a trusted partner to the nation’s leading airlines and retailers, we proudly deliver millions of meals and exceptional service experiences every year across 43 sites throughout the United States. Built on a legacy of operational excellence, culinary expertise, and continuous innovation, we are committed to setting the industry standard in aviation culinary, airline services, last-mile logistics, and retail commerce. From the kitchen to the runway, our teams work together to deliver quality, reliability, and service at every altitude. Our people are the heart of everything we do. At Sky Chefs, a career is more than a job, it’s an opportunity to grow, lead, and make an impact in a fast-paced, team-driven environment. Join America’s first, foremost, and finest and take your career to new heights. As our Food Quality Specialist, you will play a key role in ensuring compliance with all major food safety and regulatory standards including FDA, USDA, HACCP, and our company’s Global Quality Standards (GQS). You’ll help us maintain a safe, clean, and audit‑ready environment while training and supporting our team to follow best practices. • Medical, Dental, and Vision coverage starting Day 1, • Employer‑paid life insurance and AD&D benefits, • 401(k) with company match, • Paid vacation, sick time, and holidays, • Tuition reimbursement, • Free meals and parking, • Career growth opportunities with a global organization, • Ensuring full compliance with FDA, USDA, HACCP, and company food safety standards, • Conducting GQS Internal Hygiene Process Audits to support continuous improvement, • Monitoring sanitation, food handling, temperature control, and documentation practices, • Leading training sessions on quality, hygiene, and food safety topics, • Preparing clear, effective presentations and reports for leadership and cross‑functional teams, • Supporting root‑cause investigations and corrective action plans, • Partnering closely with Operations, Culinary, and other internal teams to maintain high-quality production standards, • Building strong relationships across the facility to promote a positive, safety‑focused culture, • Experience in food manufacturing, food safety, quality assurance, or regulatory compliance, • Strong knowledge of FDA, USDA, HACCP, sanitation standards, and food safety practices, • Confidence in delivering training, presentations, and cross‑functional communication, • Strong attention to detail and ability to lead or support audits and inspections, • A collaborative mindset with the ability to influence and support teams at all levels, • Ability to work in a fast‑paced environment while maintaining accuracy and professionalism SkyChefs is an EEO and Affirmative Action Employer of Women/Minorities/Veterans/Individuals with Disabilities.

Quality Manager with Regulatory Experience - BRC/USDA This Jobot Job is hosted by: Jamal Elkhateib Are you a fit? Easy Apply now by clicking the "Quick Apply" buttonand sending us your resume. Salary: $95,000 - $135,000 per hour A bit about us: For over 70 years, we have been a powerhouse in protein manufacturing — known not just for our longevity but for leading the charge in innovation, quality, and operational precision. With multiple facilities in the industrial core of Vernon, they’ve built a reputation for delivering high-performance food manufacturing solutions at scale. What makes them different? It’s the way they blend decades of hard-earned expertise with forward-thinking tech. Each location is equipped with advanced automation and state-of-the-art systems — all designed to uphold one standard: best-in-class quality in every product, every time. Why join us? Generous Bonus Incentives - We are big on giving back Executive Visibility: Work directly with the CEO and leadership team—your voice matters here. Full Benefits Package: Medical, dental, and vision coverage to support your health and your family’s. 401(k) with 4% Match: Invest in your future with a strong company-backed retirement plan. Career Growth That’s Real: We don’t just promote—we mentor, train, and elevate from within. Collaborative Leadership Culture: This is a place where quality leaders are supported, not siloed. We build systems—and people—together. Job Details We’re looking for a hands-on, systems-oriented Quality Manager who can lead plant-level QA functions and ensure we stay fully compliant with USDA, BRC, and customer expectations, while mentoring and developing the QA team. This isn’t a clipboard-on-the-catwalk kind of job. We’re looking for someone who can own the entire quality and regulatory process, from micro testing to pre-op to internal audits, and everything in between. ️ What You’ll Be Doing: Leading and mentoring the Quality team (QA, Sanitation, and FSQA staff) Managing all plant-level USDA interactions, including daily inspections, NRs, and pre-op Leading internal and third-party audit preparation (BRC, SQF, customer audits) Overseeing HACCP and SSOP programs, including updates, training, and implementation Reviewing micro results, product holds, and release documentation Ensuring compliance with USDA, FDA, and GFSI (BRC) regulations and standards Partnering cross-functionally with Production, Sanitation, Maintenance, and R&D during trial runs and continuous improvement initiatives Leading root cause analysis and CAPA for non-conformances and customer complaints Maintaining and improving QA documentation, SOPs, and recordkeeping Supporting training programs to drive food safety culture across the facility ✅ What We’re Looking For: 5+ years in food manufacturing quality or food safety, with at least 2 years in a leadership or management role Direct experience in USDA-regulated facilities (meat, poultry, protein) Strong knowledge of BRC, SQF, or GFSI standards HACCP certified (PCQI a plus) Experience with SSOPs, micro testing, and USDA documentation Comfortable working in a fast-paced, protein manufacturing environment Systems experience with ERP platforms like SAP, DCL, or similar B.S. in Food Science, Microbiology, or related field preferred Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. 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Documentation Specialist (Quality Assurance) Food/Beverage/Dietary Supplement Industry El Segundo, CA (Hybrid – Tuesday & Thursday Onsite) 3-Month Contract (Maternity Leave Coverage) $30–$35/hr A leading company in the food/beverage/dietary supplement space is seeking a Documentation Specialist to support its Quality Assurance and Regulatory Affairs team during a maternity leave coverage. This is a 3-month contract opportunity. The role is hybrid, working onsite Tuesdays and Thursdays. Position Overview The Documentation Specialist will support Quality and Regulatory documentation processes, ensuring accuracy, compliance, and timely maintenance of finished goods and raw material records. This role will work closely with suppliers, co-packers, and internal cross-functional teams. The ideal candidate will have experience in the food, beverage, or dietary supplement industry and a working understanding of regulatory frameworks and quality systems. Key Responsibilities: Maintain and manage Quality and Regulatory documentation across the supply chain Review, draft, and publish documents, including: Certificates of Analysis (COAs) Certificates of Conformance Audit certificates Specification sheets Supplier qualification documentation Ensure documentation databases are accurate, current, and within validity timelines Upload and maintain records in SharePoint and ERP systems Support document control and change control processes Assist in developing and updating SOPs, work instructions, and forms Collaborate with Operations and Sales teams to provide documentation as needed Support new product innovation documentation requirements Qualifications 2+ years of QA/Regulatory experience within food, beverage, or dietary supplement manufacturing Bachelor’s degree in Food Science, Nutrition, Food Technology, or related scientific field strongly preferred Strong proficiency in Microsoft Excel and Word (Excel skills are critical) Experience working within ERP systems and SharePoint Understanding of GMP, HACCP, SQF, FSMA, and FDA regulations preferred Strong attention to detail and organizational skills Ability to manage heavy documentation workflows with accuracy Vaco by Highspring values a diverse workplace and strongly encourages women, people of color, LGBTQ+ individuals, people with disabilities, members of ethnic minorities, foreign-born residents, and veterans to apply. EEO Notice Vaco by Highspring is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race (including but not limited to traits historically associated with race such as hair texture and hair style), color, sex (includes pregnancy or related conditions), religion or creed, national origin, citizenship, age, disability, status as a veteran, union membership, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, political affiliation, or any other protected characteristics as required by federal, state or local law. Vaco by Highspring and its parents, affiliates, and subsidiaries are committed to the full inclusion of all qualified individuals. As part of this commitment, Vaco by Highspring and its parents, affiliates, and subsidiaries will ensure that persons with disabilities are provided reasonable accommodations. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact HR@vaco.com . Vaco by Highspring also wants all applicants to know their rights that workplace discrimination is illegal. By submitting to this position, you agree that you will be giving Vaco by Highspring the exclusive right to present your as a candidate for the foregoing employment opportunity. You further agree that you have represented information about yourself accurately and have not affirmatively misrepresented your qualifications. You also agree to maintain as confidential, to the fullest extent permitted by law, any information you learn from Vaco by Highspring about the position and you will limit disclosure of information about the position only to the extent necessary to perform any obligations in furtherance of your application. In exchange, Vaco by Highspring agrees to exercise reasonable efforts to represent you through all solicitation, job screening and resume dispersal. Privacy Notice Vaco by Highspring and its parents, affiliates, and subsidiaries (“we,” “our,” or “Vaco by Highspring”) respects your privacy and are committed to providing transparent notice of our policies. California residents may access Vaco by Highspring HR Notice at Collection for California Applicants and Employees here. Virginia residents may access our state specific policies here. Residents of all other states may access our policies here. Canadian residents may access our policies in English here and in French here. Residents of countries governed by GDPR may access our policies here. Pay Transparency Notice Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. With that said, as required by local law, Vaco by Highspring believes that the following salary range referenced above reasonably estimates the base compensation for an individual hired into this position in geographies that require salary range disclosure. The individual may also be eligible for discretionary bonuses.

Quality Supervisor -Food Manufacturing - West Coast Leader for over 75 Years This Jobot Job is hosted by: Jamal Elkhateib Are you a fit? Easy Apply now by clicking the "Quick Apply" buttonand sending us your resume. Salary: $75,000 - $110,000 per year A bit about us: We are a leading food manufacturing company with a long history of producing high-quality food products for nearly 75 years. Our commitment to quality and innovation has allowed us to maintain a strong reputation in the industry as one of the largest food processors on the West Coast. We offer a wide range of food products, all made from the freshest ingredients and processed using the latest technology. As a company that values its employees, we provide a supportive work environment that encourages personal and professional growth. We offer competitive compensation packages, health benefits, and opportunities for career advancement. Why join us? No Field work! 401(k) matching Dental insurance Employee assistance program Employee discount Flexible spending account Health insurance Health savings account Life insurance Paid time off Referral program Vision insurance Annual/Performance Bonuses Job Details Overview: We’re looking for a Quality Assurance Supervisor to lead our Food Safety and Quality Assurance (FSQA) efforts within our production and distribution facilities. This role requires a proactive leader skilled in implementing and maintaining FSQA systems, conducting audits, and ensuring adherence to industry and internal safety standards. If you are a hands-on supervisor with a background in food manufacturing and a passion for driving excellence in food safety, this opportunity is for you. Key Responsibilities: FSQA Program Management: Partner with the FSQA Manager to implement FSQA systems, processes, and procedures across production and distribution facilities, ensuring a consistent commitment to food safety standards. Audit Oversight and Compliance Monitoring: Perform scheduled food safety audits to assess facility compliance with food safety programs, Good Manufacturing Practices (GMPs), and regulatory standards. Manage GMP compliance, including PPE adherence, sanitation practices, and employee behavior. Corrective Actions and Continuous Improvement: Identify non-compliant practices on the production floor, propose corrective actions, and collaborate with production leaders to implement improvements. Maintain detailed documentation of findings and corrective measures. Sanitation and Supply Compliance: Ensure production floor sanitation standards and manage compliance with sanitizer and PPE availability at facility entry points. Oversee employee practices for maintaining hygiene when entering and exiting specific facility areas. Environmental Monitoring and Swabbing: Conduct environmental swabbing to monitor facility hygiene and create corrective action reports. Document and trend data to track compliance and address deviations. Training and SOP Management: Deliver food safety training to production teams, update SOPs, and manage documentation for all training sessions. Ensure production staff is fully trained in GMP, HACCP, and company safety policies. Data Entry and Customer Complaint Tracking: Record, trend, and analyze customer complaints, supporting the FSQA Manager in investigating claims. Provide insights on trends to drive improvements. Mock Recalls and Incident Response: Support mock recall exercises and maintain up-to-date recall documentation. Collaborate with cross-functional teams to manage incidents like foreign material contamination or temperature control issues. Qualifications: Education: Bachelor’s degree in Food Science, Microbiology, Biology, or similiar field preferred. Experience: 4-7 years in quality control, food safety auditing, or quality assurance within a food manufacturing environment. Supervisory experience in quality or food safety is a strong advantage. Certification: HACCP certification is preferred. Familiarity with FDA, USDA, and Department of Health standards is preferred. Skills: Strong organizational, problem-solving, and analytical skills with advanced proficiency in Microsoft Office (Word, Excel). Communication and Leadership: Excellent communication skills, both verbal and written, with the ability to lead and motivate teams in a compliance-driven setting. Adaptability and Multitasking: Skilled in managing multiple priorities, meeting deadlines, and navigating a dynamic work environment. Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. 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Documentation Specilaist - covering a maternity leave. El Segundo, CA (Hybrid – Tues/Thurs in office) ? $31–$44/hr ? 3-Month Contract (Maternity Leave Coverage) Hydration meets precision. We’re partnering with well-know health supplement company to find a detail-loving Documentation Specialist to support their Quality & Regulatory team during a maternity leave. If you’re the type who secretly enjoys perfectly formatted spreadsheets, well-organized SharePoint folders, and making sure every certificate is exactly where it should be… we should talk. What You’ll Be Doing You’ll be partnering closely with the current Documentation Specialist and Sr. Quality Assurance Manager to keep everything organized, compliant, and audit-ready while the team searches for a permanent Sr. Quality Specialist. Expect a healthy mix of: Reviewing and maintaining quality & regulatory documentation Drafting and managing Certificates of Analysis (COAs) and Conformance Publishing and organizing documents in SharePoint and ERP systems Supporting supplier and co-packer documentation requests Updating SOPs, specs, and forms as needed Ensuring documentation stays current, accurate, and compliant This is a paperwork-heavy, detail-driven role — ideal for someone who thrives in structured environments and enjoys keeping systems clean and compliant. What We’re Looking For ?? Strong Excel and Microsoft Office skills (Excel is a must) ?? Experience in food, beverage, or dietary supplement manufacturing strongly preferred ?? Comfort working within ERP systems and SharePoint ?? 2+ years of QA/Regulatory experience ?? Bachelor’s degree in Food Science, Nutrition, or related scientific field preferred ?? Working knowledge of GMP, HACCP, SQF, FSMA, and FDA regulations is a big plus ?? Exceptional attention to detail (the kind that catches version numbers and expiration dates without blinking) The Setup Hybrid schedule (in-office Tuesdays & Thursdays) Monday–Friday, 9am–6pm Immediate need for a 3-month maternity leave coverage If you have food or dietary supplement industry experience and love bringing order to documentation chaos, this is a fantastic opportunity to support a high-growth, mission-driven brand doing meaningful work in hydration and global impact. Interested or know someone who would be a great fit? Let’s connect! Local candidates only please. No relocation offered. Looking to hire ASAP! pay: $31-35/hr Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs. With that said, as required by local law in geographies that require salary range disclosure, Vaco/Highspring notes the salary range for the role is noted in this job posting. The individual may also be eligible for discretionary bonuses, and can participate in medical, dental, and vision benefits as well as the company’s 401(k) retirement plan. Additional disclaimer: Unless otherwise noted in the job description, the position Vaco/Highspring is filing for is occupied. Please note, however, that Vaco/Highspring is regularly asked to provide talent to other organizations. By submitting to this position, you are agreeing to be included in our talent pool for future hiring for similarly qualified positions. Submissions to this position are subject to the use of AI to perform preliminary candidate screenings, focused on ensuring minimum job requirements noted in the position are satisfied. Further assessment of candidates beyond this initial phase within Vaco/Highspring will be otherwise assessed by recruiters and hiring managers. Vaco/Highspring does not have knowledge of the tools used by its clients in making final hiring decisions and cannot opine on their use of AI products. Vaco by Highspring values a diverse workplace and strongly encourages women, people of color, LGBTQ+ individuals, people with disabilities, members of ethnic minorities, foreign-born residents, and veterans to apply. EEO Notice Vaco by Highspring is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race (including but not limited to traits historically associated with race such as hair texture and hair style), color, sex (includes pregnancy or related conditions), religion or creed, national origin, citizenship, age, disability, status as a veteran, union membership, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, political affiliation, or any other protected characteristics as required by federal, state or local law. Vaco by Highspring and its parents, affiliates, and subsidiaries are committed to the full inclusion of all qualified individuals. As part of this commitment, Vaco by Highspring and its parents, affiliates, and subsidiaries will ensure that persons with disabilities are provided reasonable accommodations. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact HR@vaco.com . Vaco by Highspring also wants all applicants to know their rights that workplace discrimination is illegal. By submitting to this position, you agree that you will be giving Vaco by Highspring the exclusive right to present your as a candidate for the foregoing employment opportunity. You further agree that you have represented information about yourself accurately and have not affirmatively misrepresented your qualifications. You also agree to maintain as confidential, to the fullest extent permitted by law, any information you learn from Vaco by Highspring about the position and you will limit disclosure of information about the position only to the extent necessary to perform any obligations in furtherance of your application. In exchange, Vaco by Highspring agrees to exercise reasonable efforts to represent you through all solicitation, job screening and resume dispersal. Privacy Notice Vaco by Highspring and its parents, affiliates, and subsidiaries (“we,” “our,” or “Vaco by Highspring”) respects your privacy and are committed to providing transparent notice of our policies. California residents may access Vaco by Highspring HR Notice at Collection for California Applicants and Employees here. Virginia residents may access our state specific policies here. Residents of all other states may access our policies here. Canadian residents may access our policies in English here and in French here. Residents of countries governed by GDPR may access our policies here. Pay Transparency Notice Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. With that said, as required by local law, Vaco by Highspring believes that the following salary range referenced above reasonably estimates the base compensation for an individual hired into this position in geographies that require salary range disclosure. The individual may also be eligible for discretionary bonuses.

Quality and Compliance Manager This Jobot Job is hosted by: Jamal Elkhateib Are you a fit? Easy Apply now by clicking the "Quick Apply" buttonand sending us your resume. Salary: $120,000 - $135,000 per year A bit about us: Well established Food Manufacturing company and leading provider of poultry and meat solutions throughout California, the Pacific Northwest, Arizona, Texas, Nevada and New Mexico. Built with two principles in mind: make a quality product and provide the best customer service possible. The Company's management and employees are committed to these principles daily. Why join us? Annual Bonus Incentives Comprehensive Benefits 401k with match Incredible Advancement Opportunities Collaborative culture and leadership Job Details Overview Essential Duties and Responsibilities: Regulatory & USDA Compliance Maintain expert‑level knowledge of USDA FSIS regulations, FDA requirements (as applicable), and state and local regulatory standards related to meat and protein processing Serve as the primary facility contact for USDA inspections, regulatory reviews, audits, and investigations Ensure ongoing inspection readiness through accurate documentation, traceability, and record retention USDA Labeling & Documentation Manage USDA label approvals, submissions, revisions, and maintenance for meat and protein products Ensure accurate tracking, documentation, and cross‑functional communication of labeling requirements and changes Oversee regulatory records management to ensure accuracy, accessibility, and audit readiness Compliance Audits & Corrective Actions Lead internal compliance audits, risk assessments, and gap analyses Develop, implement, and verify corrective and preventive action plans (CAPAs) resulting from regulatory, certification, or customer audits Ensure timely investigation, documentation, and closure of regulatory‑related customer complaints Quality Systems & Cross‑Functional Partnership Partner with FSQA, Quality, Operations, and Sanitation teams to implement and maintain robust compliance and food safety programs Support HACCP, SOPs, SSOPs, and prerequisite programs specific to meat and protein manufacturing Monitor regulatory changes, assess operational impact, and proactively implement required updates Supplier, License & Permit Compliance Manage and maintain the Approved Supplier Program, ensuring regulatory and documentation compliance Oversee business licenses, permits, and regulatory filings required for facility operation Customer & Social Compliance (Retail‑Driven) Support and lead SMETA/ethical compliance audits required by major retail and grocery customers Partner with HR and Operations to ensure compliance with labor, safety, and workplace standards Coordinate corrective actions related to customer‑driven social and ethical compliance requirements Training & Continuous Improvement Train facility personnel on regulatory requirements, compliance procedures, and documentation best practices Drive continuous improvement initiatives focused on regulatory compliance, risk mitigation, and operational efficiency Qualifications Required Direct experience in USDA‑regulated meat or protein manufacturing, including beef, pork, poultry, and/or ground products Hands‑on experience managing USDA inspections and label approvals Strong understanding of food safety, regulatory compliance, and documentation practices Proven experience leading regulatory, certification, and customer audits Ability to work effectively in a fast‑paced, production‑floor environment Preferred Experience supporting BRC or other GFSI‑recognized certifications Experience supporting SMETA or major grocery customer audits (e.g., national retailers) HACCP certification Prior leadership or mentorship experience within compliance, QA, or food safety teams Education & Experience Bachelor’s degree in Food Science, Microbiology, Animal Science, or a related field (advanced degree preferred) 5–7+ years of regulatory compliance experience in meat or protein manufacturing In‑depth knowledge of USDA FSIS regulations, HACCP, SOPs, SSOPs, and labeling requirements Strong analytical, organizational, and project management skills Excellent interpersonal skills with the ability to collaborate across all levels of the organization Ability to work under pressure, manage competing priorities, and meet tight deadlines Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy

Description: Position Summary: Performs inspection and testing of purchased materials, components and products in accordance with policy and procedures. Essential Functions: Must be able to read and comprehend drawings and basic GD&T. Performs visual, dimensional and functional inspection and testing according to documented policies and procedures. Experience with microscopes and inspecting up to 30x magnification. Records inspection and test data as prescribed by written instructions and procedures. Operates all associated test and measurement equipment as instructed and as documented in procedures. Recommends changes to policies and procedures. Documents non-conformances in Non-Conforming Material Review system. Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. We’re hiring an Incoming/Receiving Quality Inspector (Inspector II) responsible for visual inspection under 30× magnification, dimensional measurements , and support for FAI and GR&R activities in a regulated FDA/ISO 13485 environment. Need 2–5 years of experience using calipers, micrometers, and gages, strong vision/optical inspection, operating CMM skills, solid blueprint reading capability, and excellent documentation practices. Maintain inspection software for inspection process Create inspection reports including inspection images Maintain inspection records and complete inspection reports Maintain quality records of inspection Prepare post-inspection reports outlining inspection findings and detailing inspection results Perform product or process inspection utilizing standardized inspection methods Filing/storage of inspection samples and inspection documentation Implement a new quality inspection process Solve inspection problems encountered in process inspection and testing Maintain all inspection records relating to individual inspection activities Reporting, assist manufacturing in inspection and inspection training Receiving inspection equipment validation (IQ/OQ/PQ) Develop and adhere to inspection schedule and inspection quality controls Complete all test/inspection documentation Assist with the final inspection Use mechanical inspection expertise and inspection tools/equipment to perform required inspections of parts and assemblies Perform incoming inspection on all components Writing and preparing inspection reports regarding inspection and testing results Perform all inspection testing functions Create receipt inspection plans and checklists for each inspection

Job DescriptionAbout Inglewood Clinical & the RoleInglewood Clinical is part of the Irvine Clinical Research site network, the largest of its kind on the West Coast. With 5 research centers in California, we are leaders in the search for new treatments in neurology, psychiatry, and obesity medicine. Our largest area of research is in Alzheimer’s Disease prevention and treatment drug trials, and our doctors were the largest contributors in the world to the most recently FDA-approved medication in Alzheimer’s Disease. The Site Manager’s role is to lead Inglewood Clinical to excellence in operations, team cohesion, growth, quality, and participant experience.Key Responsibilities • Lead Site Operations: Oversee the entire research site, acting as the primary problem-solver for all day-to-day and ad-hoc operational needs., • Team Management: Direct and motivate a team poised for significant, immediate growth across clinical investigators, coordinators, and staff. This includes hiring (with network support), onboarding, scheduling, and performance evaluations., • Drive Financial & Enrollment Goals: Ensure the site meets all targets for participant enrollment, financial growth, and long-term business sustainability., • Clinical Study Oversight: Be accountable for the successful execution and participant recruitment for all clinical studies conducted at the site., • Compliance and Quality: Maintain data integrity and quality across all electronic systems (eSource, EDC, CTMS). Own the successful completion of regulatory requirements and sponsor monitoring visits., • Strategic Communication: Serve as the key liaison to site network management to implement strategic initiatives and coordinate with local partners for services like community outreach and imaging., • Relationship Management: Foster effective working relationships with all stakeholders: study participants, Sponsors/CROs, and staff.Required Qualifications, • Demonstrated success in managing a research site, specifically with complex clinical drug trials., • Exceptional attention to detail and proven ability to manage multiple high-priority tasks simultaneously., • Excellent communication skills, both written and verbal., • Track record of building, motivating, and sustaining a cohesive team., • Strong interpersonal, customer service, and hands-on problem-solving skills.This is a full-time employment position based in-person at our clinic in the Inglewood area: 5120 W Goldleaf Cir, Ste 250, Los Angeles, CA 90056. The estimated base salary for this position is $100k per year. In addition, this position is eligible for performance bonuses of up to $20k per year if certain goals are achieved. The company pays for 100% of health/dental/vision individual insurance costs for eligible full-time employees. Vacation (PTO) is earned at a rate of 3 weeks per year.

Job Description Kandu, Inc. is pioneering an integrated approach to stroke recovery by combining FDA-cleared brain-computer interface technology with personalized telehealth services. Our IpsiHand® device is durable medical equipment that enables chronic stroke survivors to regain upper extremity function with daily home use. Combining this advanced technology with the support of expert clinicians offers a comprehensive path to recovery–helping survivors improve mobility, independence, and quality of life. The Vice President of Operations at Kandu will lead the development and execution of a comprehensive operations strategy, spanning from production planning and resource allocation to end-to-end operational workflows. What You’ll Do • Operations Strategy & Production Planning: Develop and own the overall operations strategy, including production planning, manufacturing capacity, resource allocation, and operational workflows. Create detailed plans to ensure efficiency, quality, and scalability while satisfying market demand and supporting commercial growth., • End-to-End Operations Management: Lead day-to-day operations across manufacturing, supply chain, field operations, logistics, and device servicing. Ensure operational readiness, consistent execution, and alignment with business objectives., • In-House Manufacturing Oversight: Oversee the setup, optimization, and ongoing management of the manufacturing facility to meet strict medical device standards. Manage the assembly, testing, and release of medical devices to the highest quality standards, ensuring supply satisfies demand within an integrated operations framework., • Supply Chain & CM Management: Manage contract manufacturers (CMs), suppliers, and logistics partners to ensure quality, competitive terms, and on-time delivery of components and finished goods. Establish operational standards for sourcing, supplier performance management, materials flow, and continuity planning., • Fleet Management System: Establish and run a world-class fleet management system—including repair operations, logistics, reverse logistics, field support, and tracking of company-owned devices—to support the commercialization and service of the IpsiHand System., • Durable Medical Equipment (DME) Operations: Translate DME regulatory requirements into operational standards across device provisioning, field operations, documentation, and service workflows. Ensure compliance with DME regulations while delivering operational efficiency and consistent customer experience., • New Product Introduction (NPI): Lead the seamless transfer of new medical devices from development to production, ensuring manufacturability, serviceability, scalability, and operational readiness. Collaborate closely with R&D to integrate operations considerations early in product development., • Regulatory Compliance: Ensure adherence to all regulatory requirements (e.g., ISO 13485, 21 CFR 820, FDA DME regulations) and industry best practices throughout the operational and manufacturing lifecycle., • Quality & Continuous Improvement: Monitor and analyze operational performance and manufacturing data, identifying and resolving issues promptly. Partner with QARA to eliminate nonconformances, implement corrective actions, and drive continuous improvement across operations., • Documentation & Control: Develop and maintain accurate and comprehensive operations and manufacturing documentation, including SOPs, work instructions, batch records, and service procedures. Implement robust document control systems to ensure traceability, compliance, and consistent execution., • Inventory & Materials Management: Oversee inventory planning, materials management, and stock levels across manufacturing and field operations to support uninterrupted production and device serviceability while minimizing waste., • Team Leadership: Lead, train, and motivate operations and production personnel on new devices, processes, and procedures in a fast-paced environment. Build a strong execution culture focused on accountability, operational discipline, and continuous improvement. What You’ll Bring • 15+ years of operations leadership experience in the medical device industry (preferably in with durable medical equipment), including direct oversight of manufacturing, supply chain, logistics, and field operations (scaled from Director requirement)., • 7+ years of experience leading operations and manufacturing teams in a fast-paced environment (scaled from Director requirement)., • Deep knowledge of medical device operations, manufacturing processes, DME requirements, regulations, and quality systems., • Experience developing operations strategies, KPIs, performance frameworks, and scaling device servicing or fleet management models., • Superb organizational and planning skills, adept at managing multiple operational priorities and tight deadlines., • Exceptional communication and interpersonal skills, fostering collaboration across engineering, regulatory, quality, commercial, and operations teams., • A meticulous eye for detail and a commitment to producing the highest quality devices while running efficient and compliant operations., • Experience with fleet management, logistics, and service of active medical devices is required., • Employment eligibility to work in the United States is required. The company does not sponsor employment visas for this position at this time What We Offer • Competitive Compensation ($230,000-$250,000 p/yr + equity), • Insurance (Medical/Dental/Vision), • 401(k) with company, • Unlimited PTO & Holidays, • Life Insurance, LTD and STD Please note that the salary information is a general guidance only. Kandu Health, Inc. considers factors such as scope and responsibilities of the position, candidate’s work experience, education/training, key skills and internal parity, as well as location, market and business considerations when extending an offer. Kandu Health is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Powered by JazzHR wHlqfuLqNr

Company Overview Quantimetrix, located in Redondo Beach, California, is a company that designs, develops, and manufactures clinical laboratory quality controls. For nearly 50 years, we have delivered industry-leading products and services to the medical community. The Document Control Specialist provides comprehensive support to the Manufacturing Department, ensuring compliance with cGMP standards through meticulous administrative and technical document control. This role involves writing, reviewing, and revising Standard Operating Procedures (SOPs), batch records, corrective and preventive actions (CAPAs), planned and unplanned deviations, and conducting departmental audits. Additionally, the Document Control Specialist supports manufacturing by assisting with routine and troubleshooting laboratory experiments. The ideal candidate thrives in a fast-paced environment, demonstrates strong multitasking abilities, and approaches challenges with a positive “can-do” attitude. What You’ll Do • Author, review, and revise Standard Operating Procedures (SOPs), batch records, and other controlled documents to meet Manufacturing Department’s cGMP and regulatory requirements., • Conduct internal departmental audits to ensure compliance with regulatory and company standards., • Support root cause analysis and assist in developing preventive measures to ensure long-term compliance., • Participate in continuous improvement initiatives by optimizing documentation processes and enhancing operational efficiency., • Train and guide manufacturing personnel and document control systems, SOPs, and regulatory requirements., • Assist with troubleshooting complex manufacturing and routine laboratory processes to resolve technical challenges as well as meet manufacturing demand., • Support the Manufacturing Department by conducting feasibility experiments to support Quality Validation protocols., • Support the department in inventory management., • Act as a liaison between the quality and manufacturing departments to ensure alignment and effective communication. What We’re Looking For • 2+ years of experience in document control, quality assurance, or manufacturing in a cGMP-regulated environment., • Strong knowledge of cGMP, FDA regulations, and quality management systems., • Excellent organizational, analytical, and problem-solving skills., • Ability to manage multiple priorities., • Knowledge of working with ERP systems (e.g., SAP, IQMS) is preferred., • Strong knowledge of Microsoft Word, Excel, PowerPoint., • Routine computer entry, word processing, spreadsheets and graphics. Why Join Us • Work on impactful products that support the medical and clinical laboratory community., • Collaborative team environment with opportunities for growth and development., • Play a key role in improving processes, quality, and operational excellence. Compensation The hourly range for this position is $30 - $35 an hour and will be determined based on experience, skills, education, certifications, and location. Benefits • Medical, dental and vision benefits, • Life insurance, • 401K match, • FSA, • PTO, • Educational assistance program, • Employee Discounts provided through PEO, • Employee Assistance Program Apply now and help us bring our products to patients worldwide!

As Graphic Designer & Junior Marketing Coordinator, you will support the company’s design, branding, marketing, social media and operational initiatives across digital platforms, physical locations and internal communications. This role is dynamic and collaborative, requiring both strategic thinking and hands-on execution. Responsibilities include, but are not limited to: Content Creation & Social Media • Collaborate with teams to develop and execute social media content strategies across platforms including Instagram and TikTok., • Create engaging photo, video, and graphic content aligned with brand voice and marketing initiatives., • Stay informed on emerging social media trends and platform best practices to keep brand content relevant and competitive., • Capture and produce content during events, store visits, and brand activations. Creative Graphic Design & Brand Assets • Design printed and digital marketing materials including promotional graphics, menus, signage, social media assets, and other brand collateral., • Assist with maintaining the company’s overall brand “look and feel” across all locations and marketing channels. Marketing Campaigns & Product Launches • Contribute to the ideation and execution of marketing campaigns, product launches, and promotional initiatives., • Support communication and rollout of new products or promotions through internal memos, emails, text communications, and social media announcements. Digital Platforms & Website • Assist with website updates and ensure digital content remains current and aligned with brand messaging., • Maintain and update in-store digital platforms including TVs and digital menus across locations., • Utilize emerging tools, including AI technologies, to help streamline workflows and improve productivity. Packaging, Labeling & Compliance • Assist with product labeling and packaging design and implementation., • Collaborate with the operations team to ensure labeling and packaging meet regulatory requirements, including FDA and CDPH standards. Partnerships, Outreach & Activations • Assist with outreach and coordination of influencer, celebrity, and partnership opportunities., • Support development of private labeling partnerships and other strategic collaborations., • Assist with planning and execution of brand events, activations, and partnerships. Operations & Reporting • Maintain project trackers, monitor deadlines, and help ensure timely completion of marketing and operational tasks., • Provide daily end-of-day status updates summarizing completed tasks and outstanding items., • Provide marketing and administrative support to leadership and team members as needed. Professional Expectations • Maintain excellent organizational and communication skills while managing multiple projects simultaneously., • Demonstrate a proactive, solution-oriented mindset and follow through on assignments until completion.

Our client seeks an System Administrator for a 12 Months Project in Los Angeles, CA . Below is the detailed requirement Job Title: System Administrator Work location : Los Angeles, CA Duration: 12 Months This is infrastructure hardware support role people having experience in EMC Dell/ VMware etc. mentioned below. Not a development role Nature and Scope of Job:The Senior Systems Administrator for MES is the technical expert responsible for managing the entire IT infrastructure stack that supports 24/7 manufacturing operations—from the physical hardware (Cisco UCS) and virtualization layer (VMware) to core network services (AD) and application delivery (Citrix). A critical component of this role is the design, implementation, and management of backup and disaster recovery solutions to guarantee data integrity and minimize downtime in a highly regulated environment Job Description: • Bachelor's degree preferably in Computer Science, Information technology, Computer Engineering, or related IT discipline or equivalent experience with 12+ Minimum Experience Experience: 5+ years of experience in systems administration within a production/manufacturing environment. Prior experience supporting an MES (e.g., Siemens, Emerson) is highly desirable.Backup Solutions: Expert knowledge of enterprise backup software (e.g., Veeam Backup & Replication, Dell EMC Avamar) and related storage targets (SAN, NAS, Cloud, e.g., Tintri, HP Storage).VMware & Hardware: Deep knowledge of vSphere, ESXi, vCenter, and Cisco UCS hardware manage, • ment.Microsoft: Expert knowledge of Windows Server OS, Active Directory, GPO, DNS, and, • DHCP.Citrix: Proficiency with Citrix Virtual Apps/Desktops and application virtualization technologies.Network Fundamentals: Working knowledge of Cisco switches (Layer 2/3 configurations, VLAN management), Wireless Access Points, and basic Voice Gateway troubleshooting. Primary Responsibilities: Backup & Disaster Recovery Management: • Design, implement, monitor, and manage enterprise backup solutions (e.g., Veeam, Commvault, Dell EMC Avamar) for all virtualized and physical servers supporting the MES envir, • onment.Develop, test, and maintain disaster recovery (DR) plans and procedures to ensure data recoverability and business continuity objectives (RPO/RTO) are met for all critical MES data and systems.Ensure data integrity and compliance with GxP regulations regarding data archival, retention policies, and audittrails. Infrastructure Management (VMware & Cisco UCS): Design, implement, and maintain highly available VMware vSphere infrastructure and Cisco UCS hardware to ensure optimal performance and scalability for MES applications. Core Services Administration (Windows Server & AD): Administer Windows Server OS, Active Directory (AD-DS), GPOs, DNS, and DHCP services, ensuring secure and compliant operations within the manufacturing domain. Application Delivery (Citrix):Manage the Citrix environment (Virtual Apps/Desktops) for secure and efficient delivery of the MES application to plant floor workstations and remote users. MES Support: Provide expert-level troubleshooting (Tier 3/4) for infrastructure issues impacting the MES platform, collaborating with application owners and vendors. Compliance and Documentation: Ensure all system changes and operations comply with regulatory standards (FDA, GxP).Maintain detailed technical documentation, including backup configurations, D/R plans, and Standard Operating Procedures (SOPs

Design Quality Engineer — Process Development to support new product introduction (NPI) and production scale-up activities within the diabetes medical device space. This individual will drive process validation strategies, lead process risk management (PFMEA), and serve as a critical crossfunctional liaison between internal Supplier Quality, R&D, Contract Manufacturers, and NPI teams. The ideal candidate brings deep expertise in process development, FMEA methodologies, and regulatory compliance —A proven track record of resolving critical production issues during scale-up and mentoring engineering teams is essential. Process Development & Validation • Develop P-diagrams, Input-Process-Output (IPO) matrices, process characterizations, and test method validation (TMV) strategies for NPI programs., • Author and manage Master Validation documents (IQ/OQ/PQ/EQV/TMV) for new product introductions and production scale-up., • Apply methodologies including Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly (DFMA), and Cell Operating System (COS). • Drive risk mitigation approaches by integrating qualification parts early in process development phases Process Risk Management & Risk Navigation • Facilitate and generate Process Failure Modes Effects Analysis (PFMEA) documents for manufacturing processes during NPI and scale-up., • Maintain strong working knowledge of design risk documentation (RAD, DFMEA, HRA) to critically analyze process-related failures and identify gaps., • Recognize when process findings have design risk implications and escalate appropriately to Design Quality Assurance (DQA) partners for design risk assessment decisions. • Leverage understanding of risk documentation during root cause investigations and critical analyses to ensure comprehensive disposition., • Conduct thorough root cause investigations using A3 Problem Solving methodology, fishbone diagrams, 5-Why analysis, and brainstorming techniques Cross-Functional Engagement & Collaboration • Serve as the primary quality interface between internal Supplier Quality Engineering (SQE), R&D cross-functional teams, Contract Manufacturers, and NPI program teams • Facilitate regular cadence of alignment discussions with Supplier Quality and vendors to implement updated control plans, inspection criteria, and risk documentation. • Collaborate with R&D teams to translate design intent into manufacturable process parameters during design transfer, • Partner with NPI groups to ensure seamless transition from development builds through production qualification and commercial readiness., • Ensure alignment between contract manufacturers and internal teams on deliverables, expectations, and quality standards., • Bridge QMS gaps between contract manufacturing partners and internal quality systems, standardizing documentation templates and expectations., • Direct comprehensive drawing reviews with cross-functional partners ensuring all Critical Dimensions are accounted for incoming and in-process inspections. Production Scale-Up Support & Crisis Management • Lead cross-functional teams through high-pressure production holds and scale-up challenges during NPI commercialization., • Conduct root cause investigations (A3 methodology) and implement Corrective and Preventive Actions (CAPA)., • Strategize and guide engineering teams to deploy effective investigation approaches for supplier and manufacturing issues., • Proactively identify production risks during scale-up and drive containment/resolution before they impact launch timelines. Statistical Analysis & Data-Driven Decision Making • Perform statistical analyses including hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, and GR&R using Minitab., • Utilize statistical process control (SPC), I-MR charts, Box plots, and Normality & No Required Skills & Qualifications • 4+ years applying DRM, DFSS, DFMA, and COS methodologies in medical device process development, • 4+ years facilitating and generating PFMEA documents; strong working knowledge of DFMEA and design risk documentation (RAD, HRA) sufficient to identify gaps and escalate appropriately • 4+ years developing process parameters, DOEs, P-diagrams/IPO matrices, process characterizations, and process validation strategies (IQ/OQ/PQ/TMV), • 4+ years performing statistical analysis (hypothesis testing, confidence/tolerance intervals, regression, capability analysis, DOEs, GR&R) in Minitab, • 4+ years working within FDA QSR, ISO 13485, ISO 14971, ISO 11135, ISO 11737, and EU MDR regulatory frameworks, • 4+ years coordinating Design Control, Design Verification, Process Validation, root cause investigations, and CAPA activities, • Demonstrated experience collaborating cross-functionally with Supplier Quality, R&D, Contract Manufacturers, and NPI teams in a matrixed environment, • Demonstrated experience utilizing Good Manufacturing Practices (GMP) and FMECA Preferred Qualifications • Experience with CGM (Continuous Glucose Monitoring) sensors or insulin pump systems, • Proven track record resolving production holds during NPI commercialization and scale-up, • Experience managing design transfer and production scale-up activities with contract manufacturers., • Experience serving as the quality "bridge" between multiple external partners and internal stakeholders, • Experience with problem-solving methodology, • CQE (Certified Quality Engineer) or Six Sigma Black Belt certification, • Familiarity with automated manufacturing lines and assembly-level process optimization Required: • Master's degree in Mechanical Engineering, Biomedical Engineering, or related field AND 5+ years of experience in process development, manufacturing, or quality engineering for medical devices OR • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related engineering field AND 7+ years of experience in process development,, • manufacturing, or quality engineering for medical devices

Job Title: Formulator / Sr. Formulator Location: Chatsworth, CA Company Summary At Vytalogy, we believe everyone should have access to better health and nutrition to fuel their wellness. As a leader in the vitamins, minerals, and supplements (VMS) industry, we’re home to trusted brands Natrol and Jarrow Formulas. With locations in Los Angeles, CA, Boulder, CO, and Haslet, TX, we bring science-backed wellness products to consumers nationwide. Summary: The Formulator is responsible for all aspects of the technical product and process development for solid dosage form (capsules, tablets, and powders). This role effectively utilizes standard best practices and procedures in product and process development. Supports technology advancements to drive innovation and point of difference for the brands. Interfaces with Marketing, Manufacturing, Technical Operations, Quality, Purchasing and other cross-functional areas to accomplish project goals. Your primary activities will include but are not limited to: • Formulator needs to develop prototype samples, plans for scale up batches for stability test, prepares product samples for stability test, stores and records samples in laboratory., • Assures that materials used and materials manufactured meet written specifications for physical and chemical attributes necessary for product manufacture., • Formulator keeps all equipment and tools clean and in their proper storage area. Formulator must understand how to operate machinery including blenders, granulators, coaters, mills, compactors, etc., • Performs raw material evaluations, documents all data collected during testing and evaluates same for completeness and correctness, • Performs and/or assists in various phases of R&D and product development activities. Processes lab batches and scale up batches using scales, blenders, tablet presses, encapsulators, coaters, granulators, mills, rollers, compactors, etc. You’ll need the following (minimum qualifications): • Bachelor’s degree of Science in Chemistry or Nutrition is desired plus 5 years of relevant experience in product development in the Nutraceutical or Pharmaceutical industry, or Masters degree plus 0-2 years’ relevant experience in product development in the Nutraceutical or Pharmaceutical industry. (other CPG experience will be considered depending on relative applications)., • Comprehensive knowledge and practical experience in product/process development, processing laboratory techniques, regulatory requirements, and a firm foundation in basic sciences., • Demonstrated success in formulating, scaling up and commercializing complex solid dose formulations, including hands-on lab experience. Ability to adapt to change and to find creative solutions to keep projects on track., • Possess knowledge of technical standards and techniques, • Must be familiar with the equipment and techniques used in formulation of tablets, capsules and powders, • Requires understanding of Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations and Current Good Manufacturing Practices (cGMPs), • Must possess ability to evaluate physical and mechanical properties of raw materials to be used in the formulations and the ability to objectively evaluate the resulting physical properties of the finished product., • Demonstrated ability to effectively communicate within a cross-functional team environment especially with manufacturing, operations, quality, and maintenance., • Understanding of product lifecycle management and associated software tools., • Willing to travel between 10% - 25% as necessary. A reasonable estimate of the current salary range for this position is $90,000 to $140,000. Actual compensation offered may vary depending on skill level, experience, and/or education. Vytalogy Wellness LLC offers a competitive total rewards package, which includes medical, dental, and vision insurance, 401K with company matching contributions, paid sick days, vacation, and holidays, paid parental leave, short-term and long-term disability coverage, life insurance, and wellness programs. Vytalogy Wellness, LLC is an Equal Opportunity Employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. Vytalogy Wellness, LLC collects personal information of job applicants in connection with our recruitment and hiring activities. For more information, including the categories of personal information we may collect, the purposes for which we collect such personal information and the rights you can exercise over our use of your personal information, see our _.

Overview The Preclinical Scientist will coordinate, scientifically plan, analyze, and document preclinical studies for the Company. The role is intended for a scientist with graduate-level training and sufficient scientific judgment to translate product-development questions into practical, defensible preclinical study designs, while working with internal and external senior subject matter experts as needed. The position will coordinate and scientifically support a range of primarily live-animal preclinical studies, and may also include related microbiology, animal cadaver or foodstuff testing, human cadaver testing, histopathology, biocompatibility, bench performance, and other translational studies. Most studies are expected to be performed off-site through external Contract Research Organizations (CROs), testing laboratories, universities, military facilities, or other subcontractors. Limited travel may be required for study initiation, in-life observations, troubleshooting, data review, or vendor oversight. In addition to coordinating study logistics, this position is responsible for providing scientific thinking and analysis across preclinical programs. This includes helping select appropriate animal models and endpoints, developing and reviewing scientifically sound protocols, anticipating study limitations, evaluating biological and statistical relevance, interpreting data in the context of device and combination-product development, and communicating conclusions to cross-functional teams. Preclinical Scientist will serve as the coordination point for preclinical studies and will routinely coordinate with: • Internal to Critical Innovations, • Production & Engineering (e.g., test devices, control devices, IFUs), • Quality Assurance & Regulatory Affairs (e.g., study regulatory requirements, reporting review), • Technical Operations, including the R&D Laboratory and CMC functions, for assay development, laboratory protocols, analytical methods, specimen processing, and CMC-related study support., • Grants & Contracts, including contract-driven program management, milestone tracking, sponsor reporting requirements, and deliverable coordination., • Shipping and receiving (e.g., to send and receive control and test items, as needed), • External to Critical Innovations, • Contract Research Organizations (e.g., performance of studies), • Testing laboratory sites (e.g., testing setup, performance of specific tests on study specimens, histopathology), • Statisticians, consultants, and other subcontractors, • Military subject matter experts and/or facilities (as applicable) This job will encompass the design, development, implementation, oversight, and management of a variety of preclinical animal studies of Critical Innovations' products to ensure study goals (e.g., safety, efficacy, performance, biocompatibility) are met. It additionally includes the analysis of data received from the studies, as well as communicating findings internally and documenting them in applicable Design History Files in compliance with ISO 13485. Additionally, this position includes providing data and analysis for authorship of manuscript, abstracts, presentations, and intellectual property. Familiarity and previous experience with relevant Regulatory requirements for devices and combination products that are either device- or drug-led (e.g., FDA's Quality System Regulation 21 CFR Part 820, Good Laboratory Practices (GLP), ICH, cGMP for pharmaceutical products 21CFR Parts 210 and 211), Quality Management System ISO 13485:2016, ISO 10993 Biocompatibility are a significant benefit. The ideal candidate will be able to think critically, identify study risks before execution, recognize scientific and documentation gaps, and communicate complex scientific findings in a practical manner for engineering, regulatory, quality, clinical, and management audiences. This position is expected to provide meaningful scientific input and independent analysis while also remaining hands-on with study coordination and execution. This position is designated as an on-site role and is expected to be performed primarily at the Company's assigned work location. Any work-from-home, hybrid, telecommuting, or other flexible work arrangement is available only if approved under applicable Company policies and business needs, and may be modified, suspended, or discontinued by the Company at any time, consistent with applicable law. Reports to: Director of Preclinical & Clinical Science Duties and Responsibilities: The responsibilities of the Preclinical Scientist typically include: • Contribute to preclinical study planning, including model selection, endpoint definition, experimental controls, success criteria, sample size rationale, and study-risk assessment., • Develop, review, and refine animal models and related test methods, in conjunction with internal and external expertise, to demonstrate product safety, efficacy, performance, usability, durability, biocompatibility, or mechanism of action., • Author and/or assist with scientific review of study protocols, amendments, data collection forms, study plans, acceptance criteria, final reports, regulatory submission sections, abstracts, manuscripts, presentations, and internal technical memoranda., • Participate in cross-functional preclinical strategy discussions and help translate product-development questions into testable hypotheses and practical experimental designs., • Evaluate the scientific quality, regulatory appropriateness, and operational feasibility of CRO and laboratory proposals, including budgets, timelines, methods, endpoints, and deliverables., • Obtain quotes, prepare or support purchase orders, supervise subcontracted study work, process invoices, coordinate shipments, and support vendor payment for CROs and related vendors., • Coordinate and supervise external study execution, including study kickoff, test article preparation, shipping, in-life monitoring, protocol deviations, issue resolution, specimen handling, pathology review, data transfer, and closeout., • Analyze quantitative and qualitative study data; interpret biological, physiological, engineering, histopathological, microbiological, and performance findings; and communicate conclusions, limitations, and recommended next steps., • Identify and document study deviations, data anomalies, adverse findings, and technical risks; work with Quality, Regulatory, and Research leadership to determine impact and appropriate follow-up., • Support regulatory strategy by preparing or reviewing preclinical testing content for FDA submissions and other regulatory deliverables, including rationale for test selection, GLP status, animal model relevance, and evidence sufficiency., • Maintain applicable Design History File documentation, study records, raw data summaries, risk-analysis inputs, technical reports, and traceability to product requirements or program objectives., • Collaborate with Research & Laboratory, Production & Engineering, Quality & Regulatory, Grants & Contracts, and external subject matter experts to ensure study outputs meet technical, quality, regulatory, and sponsor needs., • Provide scientific input for grant proposals, sponsor reports, peer-reviewed manuscripts, conference abstracts, presentations, patent disclosures, and intellectual property strategy., • Support junior staff or coordinators by sharing scientific rationale, protocol-review feedback, data-interpretation input, documentation practices, and vendor-oversight practices. Skills and Experience: • Sound scientific judgment and ability to apply the scientific method to translational research, device development, and preclinical animal studies., • Experience designing, executing, monitoring, coordinating, or analyzing preclinical animal studies, preferably involving medical devices, combination products, trauma, hemostasis, resuscitation, physiology, neuroscience, surgery, critical care, or related fields., • Working understanding of experimental design, appropriate controls, endpoint selection, biological variability, bias reduction, data integrity, and interpretation of preclinical findings., • Ability to perform scientific data analysis, including descriptive statistics, graphical data review, outlier assessment, study-limitations analysis, and interpretation of statistical output., • Excellent written communication, including the ability to author or substantively contribute to protocols, technical reports, regulatory summaries, manuscripts, abstracts, and internal scientific summaries., • Strong oral communication and ability to present scientific information to cross-functional technical and non-technical audiences., • Experience interacting with CROs, testing laboratories, vendors, consultants, pathologists, veterinarians, statisticians, government sponsors, or academic collaborators is preferred., • Familiarity with one or more quality or compliance frameworks relevant to preclinical development, such as GLP, GMP, ISO 13485, FDA Quality System Regulation, ISO 10993, IACUC, ACURO, ICH, or related standards., • Ability to work within controlled-document, design-control, and quality-system expectations, including disciplined document review, change control, traceability, and record retention., • Strong project-management capability, including schedule management, vendor oversight, issue escalation, milestone tracking, and completion of deliverables under defined timelines., • High attention to detail and ability to identify discrepancies, scientific inconsistencies, missing controls, unsupported conclusions, and documentation gaps., • Self-motivated, highly organized, and able to work independently while coordinating effectively with a cross-functional team., • Proficiency with Microsoft Office Suite. Experience with statistical, graphing, reference-management, electronic data capture, or quality-management tools is beneficial., • Ability to travel occasionally for CRO site visits, study observations, sponsor meetings, or vendor oversight. Education and Training: • Master's degree or PhD in biology, physiology, neuroscience, veterinary science, biostatistics, or a related scientific discipline required. PhD preferred., • For candidates with a Master's degree, typically 3+ years of relevant preclinical, translational research, medical device, biotechnology, pharmaceutical, or CRO experience is expected., • For candidates with a PhD, relevant graduate, post-graduate, industry, CRO, translational, or applied preclinical research experience is expected; industry experience is preferred but not required., • Direct experience with preclinical animal study procedures, IACUC or ACURO submissions, GLP or non-GLP study justification, and external CRO oversight is preferred., • Knowledge or experience with FDA preclinical expectations for medical devices or combination products, ISO 13485, ISO 10993, 21 CFR Part 820, 21 CFR Part 58, and/or 21 CFR Parts 210 and 211 is preferred., • Authorization to work in the United States indefinitely without restriction or sponsorship is required. Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veterans' status, or any other characteristic protected by law. To conform to U.S. Government Department of War regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State. Benefits: • 401(k) Safe Harbor Plan, • Healthcare Insurance: Medical, Dental and Vision, • Other Insurance: Life Insurance and Long-Term Disability (LTD) Insurance, • Time Off: Paid Time Off (PTO), Paid Sick Leave, Paid Holidays, and Paid Bereavement Leave, • Tuition Reimbursement Program, • Performance Bonus, • Incentive Unit Plan, • Flexible Schedule, • Lunches, Snacks, Events Schedule: Monday to Friday Salary: $115,000 – $155,000 per year _

Job Description & Skill Requirement: -Evaluate product issues to ensure patient, user and security risk are assessed, and acting as the lead Design Quality Engineer for Post-Market Design Changes on Capital Hardware -Update DFMEA and DHF documents as needed as part of the post market design change management process -Provide comprehensive support to Post Market Development Teams with a focus on Design Quality and Risk Management -Collaborate with different departments across the organization to understand and review data to assess the patient/user risk associated with the post market life-cycle phase -Support Complaint trending and Severity trending signal dispositions -Maintain risk management file throughout product lifecycle, ensuring the latest knowledge on risk reflected in the risk documentation -Assure compliance to organizational procedures, regulatory requirements and industry standards, and timely completion of assigned CAPAs and audit findings -Makes decisions and proposes solutions based on calculated risks identified through data analysis -Assist with protocol and implement process validation procedures in accordance with QSR, FDA and international guidelines -Coordinate activities through the Quality Engineering Manager and report regularly on the progress of activities Qualification: -Bachelors degree required -Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience -Excellent communication and technical writing skills -Experience in Manufacturing and/or Electro-Mechanical Medical Device risk assessments -Working knowledge of Quality System Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC) Paid Leave, Health Insurance, Group life insurance, Disability, 401(K) The expected salary range for this position is between $55,500 to $99,500 annually. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, base salary of internal peers, prior performance, business line, and geographic/office location.

Job Title: Technical Project Manager – Controls & Data Systems Location: Northridge, CA (100% on-site) Department: Manufacturing Science & Technology (MSAT) Reports To: Senior Manufacturing Operations Manager – MSAT Duration: 6-Month W2 Assignment (Potential to Extend or Convert) Pay Rate: $78/hour Company Overview A global organization specializing in advanced drug delivery systems partners with leading pharmaceutical companies to develop and manufacture complex combination products, including transdermal patches and inhalation therapies. Role Overview We are seeking a Technical Project Manager with a strong engineering background and proven project management experience to lead initiatives involving control systems, data acquisition, and pharmaceutical manufacturing processes. This role supports late-stage development, technical transfer, and commercialization, with a focus on execution, compliance, and client engagement. Key Responsibilities Project Management & Leadership • Lead technical projects from initiation through completion, ensuring alignment with scope, schedule, and budget, • Develop and maintain project plans, risk assessments, and resource strategies, • Coordinate cross-functional teams across R&D, Quality, Regulatory, and Operations, • Ensure compliance with GMP, FDA, and regulatory requirements Technical Execution • Oversee design, implementation, and optimization of control systems and data acquisition platforms, • Support technical transfer activities for pharmaceutical manufacturing programs, • Guide system integration, testing, and validation efforts, • Apply Quality by Design (QbD) principles and statistical tools (DoE, FMEA, Gage R&R) Client & Stakeholder Engagement • Serve as the primary point of contact for clients throughout the project lifecycle, • Lead project kick-offs, technical reviews, and issue resolution, • Clearly communicate technical concepts to internal and external stakeholders, • Support client audits and regulatory inspections Continuous Improvement • Identify opportunities to improve process robustness, product quality, and efficiency, • Contribute to Lean initiatives and best practice implementation Qualifications • Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Electrical, Biomedical, or related), • PMP certification (or equivalent) required, • 7+ years of experience in pharmaceutical manufacturing, • Experience managing technical projects in regulated or CDMO environments, • Strong background in control systems, automation, and data acquisition, • Knowledge of cGMP and regulatory requirements, • Excellent communication, leadership, and stakeholder management skills Preferred Skills • Experience with transdermal patch or inhalation (MDI) manufacturing processes, • Familiarity with coating, laminating, die-cutting, or filling/crimping operations, • Experience supporting CMC documentation for regulatory submissions (NDA/ANDA), • Lean Six Sigma or continuous improvement certification Please submit your resume in Word or PDF format to be considered.

COMPANY OVERVIEW Chicken of the Sea Frozen Foods (COSFF) is a leading importer and marketer of frozen and refrigerated seafood in North America. Founded in 2006 to build on the heritage of the iconic Chicken of the Sea brand, COSFF has grown into one of the top U.S. shrimp importers with a strong presence in crab meat, tuna, and value-added seafood products across all trade channels. A wholly owned subsidiary of Thai Union – one of the world’s largest seafood companies and a global sustainability leader ranked #1 in the Food Products Industry on the 2024 Dow Jones Sustainability Indices (DJSI) – COSFF is guided by Thai Union’s SeaChange® strategy and its vision of “Healthy Living, Healthy Oceans.” Headquartered in El Segundo, CA, COSFF blends a dynamic, entrepreneurial culture with a deep commitment to sustainability and innovation. Our six core values of Collaboration, Responsibility, Innovation, Respect, Humility, and Passion define who we are and how we lead the industry forward. Role Objectives: Responsible for coordinating, monitoring, and ensuring the compliant and timely movement of inbound frozen seafood shipments from various global origins to U.S. warehouses. Oversee FDA-related logistical activities, documentation accuracy, and cross-functional communication to minimize delays and ensure regulatory compliance. This role requires proactive information monitoring, issue management, strong attention to detail, and the ability to operate independently while supporting multiple stakeholders within the supply-chain. The salary range for this role is $25-$26/hr. (DOE) Essential Duties & Responsibilities 1. Inbound Shipment Management • Coordinate and track international shipments from origin through warehouse delivery., • Manage ISF filings, PO tracking, document review, last free day monitoring, warehouse manifests, and goods receipt activities., • Monitor shipment milestones including ETA, port arrival, customs clearance, warehouse receipt, and delivery status., • Maintain accurate shipment data within SAP/ERP systems to support inventory planning and supply chain visibility., • Collaborate with steamship lines, carriers, customs brokers, and logistics providers to ensure efficient cargo movement. 1. FDA & Regulatory Coordination • Monitor FDA examinations, holds, import alerts, and other regulatory activities affecting inbound shipments., • Communicate FDA hold reports and regulatory updates to internal stakeholders., • Partner with Quality Assurance, customs brokers, and warehouse teams to manage detained, restricted, or non-compliant inventory., • Coordinate and track resolution of FDA-rejected, delayed, or detained shipments through completion. 1. Documentation & Compliance • Review and validate commercial invoices, packing lists, Certificates of Analysis (COAs), and regulatory documentation., • Ensure all import documentation is accurate, complete, and compliant before ERP/SAP processing., • Maintain organized records of customs entries, FDA filings, and shipment documentation., • Support compliance with U.S. Customs regulations, FDA requirements, and company policies. 1. Warehouse Coordination • Provide operational instructions to warehouses regarding inbound shipments and FDA-held inventory., • Coordinate product release activities in partnership with Quality Assurance teams., • Respond to warehouse inquiries related to shipment manifests, inventory transfers, and product status., • Ensure timely communication regarding inbound inventory availability and regulatory restrictions. 1. Financial & Invoice Support • Support Accounts Payable and Finance teams with documentation required for invoice processing and reconciliation., • Review customs broker, steamship line, carrier, and freight invoices for accuracy., • Follow up with suppliers and logistics partners to obtain missing or corrected documentation required for customs and FDA clearance., • Assist with freight and logistics cost tracking and reporting. 1. Cross-Functional Collaboration • Partner closely with Purchasing, Quality Assurance, Commercial, Warehouse, and Logistics teams., • Coordinate with suppliers, customs brokers, freight forwarders, and transportation providers to resolve shipment issues., • Ensure alignment across departments regarding shipment priorities, inventory status, and regulatory concerns., • Provide timely updates on critical supply chain activities and exceptions. 1. Reporting & Analysis • Prepare and distribute FDA hold reports, shipment status updates, inventory movement reports, and related metrics., • Track container status, regulatory risks, and supply chain performance indicators., • Analyze trends, identify risks, and escalate concerns to management with recommended solutions., • Support data-driven decision-making through reporting and operational analysis. 1. Issue Resolution & Continuous Improvement • Investigate shipment delays, compliance issues, and operational challenges., • Collaborate with internal and external stakeholders to identify root causes and corrective actions., • Recommend process improvements to enhance efficiency, compliance, and supply chain performance., • Support continuous improvement initiatives across inbound logistics operations. Other Duties • Assist with general inbound logistics activities, documentation processing, and special projects as needed., • Support the Inbound Logistics Supervisor in reviewing customs broker, steamship line, and carrier invoices., • Request and validate supporting documentation when required., • Perform additional duties and responsibilities as assigned by management. Skills & Qualifications • Bachelor's degree in supply chain management, Business Administration, Logistics, or a related field; equivalent experience may be considered., • 3+ years of experience in inbound logistics, import operations, supply chain coordination, or related field., • Experience working with SAP or other ERP systems., • Working knowledge of FDA regulations, U.S. Customs procedures, import documentation, and international shipping processes., • Strong organizational, analytical, and problem-solving abilities., • Excellent communication and relationship-building skills., • Ability to manage multiple priorities in a fast-paced environment while maintaining attention to detail., • Proficiency in Microsoft Excel and reporting tools. Preferred Qualifications • Experience within the seafood, food manufacturing, food distribution, produce, protein, or CPG industries., • Experience managing FDA holds, import alerts, examinations, and regulatory reporting., • SAP experience, preferably with MRP and inventory management modules., • Experience supporting high-volume inventory environments and global supply chain operations., • Knowledge of international freight forwarding, customs brokerage, and warehouse operations. DISCOVER WHAT’S POSSIBLE AT CHICKEN OF THE SEA FROZEN FOODS • Drive What’s Next – Quality and innovation are at the heart of everything we do. We’re redefining what’s possible in seafood—developing sustainable solutions, introducing new value-added products, and continuously improving how we source, process, and deliver to advance our mission of “Healthy Living, Healthy Oceans.”, • Grow With Us – Your growth fuels our success. We offer the tools, learning programs, tuition assistance, and mobility opportunities to help you reach your potential. You’ll gain hands-on experience working with many of the industry’s most recognized customers and operators—an invaluable opportunity to learn, collaborate, and grow alongside the best in the business., • Make Waves Together – Experience the impact and agility of a smaller company backed by the reach and resources of a global organization. At COSFF, your work makes a visible difference while connecting you to opportunities across Thai Union worldwide. To recognize the differences being made and to pay it forward, we foster a culture of appreciation – celebrating our Crew’s achievements and giving back through community volunteer programs that support our sustainability goals., • Thrive With Us – We offer comprehensive benefits and perks designed to support your wellbeing, financial security, and continued growth., • Health & wellness: Comprehensive medical, dental, and vision insurance options; employee assistance program, • Financial future: 401(k) with company match, HSA option with employer contributions, company-paid life insurance, • Work / life balance: Generous paid time off, paid parental leave, family-friendly benefits, hybrid / remote roles, flexible hours, • Learning & growth: Training and tuition assistance program, • Perks: Internet, phone, and wellbeing stipends READY TO JOIN OUR CREW? To be the world’s most trusted seafood leader, we rely on people who live our values every day – Passionate, Humble, Respectful, Responsible, Collaborative, and Innovative. If this sounds like you, and you’re ready to make a meaningful impact in the seafood industry, we’d love to hear from you!

Radio Frequency Physicist – Beauty Industry Shape the Future of Waterless Beauty with Olive Tree People Waterless Beauty is the fastest growing sector in the entire beauty industry, and we are the fastest growing waterless beauty brand disrupting the industry. Position Overview Oliveda is seeking a highly skilled Radio Frequency (RF) Physicist with experience in the beauty, skincare, or medical aesthetics industry. This role focuses on the development, modeling, and optimization of RF-based technologies used in advanced beauty and skincare devices. The ideal candidate combines strong theoretical expertise in electromagnetics with hands-on experience in RF systems applied to skin treatment technologies such as tightening, lifting, and rejuvenation. Key Responsibilities • Apply advanced electromagnetic theory to design and optimize RF systems for beauty and aesthetic applications, • Develop and model RF-based technologies used in skincare and cosmetic devices, • Analyze electromagnetic field interaction with biological tissue (skin and subdermal layers), • Conduct simulation and modeling of RF energy distribution using industry-standard tools, • Collaborate with engineering, and product teams to develop next-generation beauty devices, • Perform testing, validation, and performance analysis of RF-based aesthetic technologies, • Support prototype development and system integration of RF hardware in beauty devices, • Develop methods for signal analysis and optimization of RF performance in cosmetic applications, • Ensure safety, efficacy, and compliance with beauty and medical aesthetic standards, • Prepare technical documentation, reports, and presentations for leadership and CEO Required Qualifications • PhD or Master’s degree in Physics, Electrical Engineering, Applied Physics, or related field with specialization in RF or Electromagnetics, • Strong background in electromagnetic theory and RF wave propagation, • Experience applying RF technologies in beauty, medical devices, or aesthetic equipment, • Experience in RF system design, modeling, and signal analysis, • Strong analytical and problem-solving skills, • Ability to translate complex physics concepts into product innovation Preferred Qualifications • Experience with RF-based aesthetic technologies (skin tightening, anti-aging, body contouring), • Knowledge of RF device architecture used in beauty or medical aesthetics, • Experience with RF testing equipment (spectrum analyzers, network analyzers, signal generators), • Familiarity with EMC/EMI standards and regulatory frameworks (FDA, CE, etc.), • Experience with advanced signal processing in biological or cosmetic applications Key Competencies • Advanced analytical thinking, • Innovation in beauty tech and skincare science, • Strong technical communication, • System-level problem solving, • Cross-functional collaboration Why Join Oliveda? • Be part of a global movement reshaping the future of skincare, • Join a fast-growing beauty brand rooted in sustainability, purpose, and innovation, • Work at the intersection of physics, beauty, and next-generation wellness technology, • Opportunity to shape breakthrough RF technologies in the beauty industry Job Details • Job Type: Full-Time, On-site (Culver City, CA), • Compensation: $110,000 – $130,000 per year (commensurate with experience), • Benefits: Medical, Dental, Vision, Life & Health Insurance, plus 401(k), • Plus $250 worth of Olive Tree People products each month, along with a 50% discount on all products

Shape the Future of Waterless Beauty with Oliveda Waterless Beauty is the fastest growing sector in the entire beauty industry, and we are the fastest growing waterless beauty brand disrupting the industry. About the Role Oliveda is seeking an experienced Sourcing & Procurement Manager to lead procurement activities within the beauty and supplements categories. This role is responsible for managing supplier relationships, negotiating contracts, ensuring product quality and regulatory compliance, and driving cost efficiency while supporting Oliveda’s premium brand standards and growth objectives. What You’ll Do • Lead sourcing and procurement strategy for beauty and dietary supplement product categories., • Identify, evaluate, and onboard high-quality global suppliers and manufacturers., • Negotiate pricing, contracts, MOQs, lead times, and commercial terms., • Build and maintain strong supplier relationships to ensure quality, reliability, and compliance., • Ensure adherence to regulatory standards (FDA, GMP, and applicable cosmetic/supplement regulations)., • Partner with Product Development, R&D, Operations, and Quality teams to support new product launches., • Monitor market trends, raw material pricing, and supply chain risks., • Manage procurement timelines to ensure consistent inventory and production flow., • Drive cost optimization initiatives while maintaining premium product standards., • Maintain accurate procurement documentation, reporting, and supplier performance tracking., • Support sustainable and ethical sourcing initiatives aligned with Oliveda’s brand values. What We’re Looking For • Bachelor’s degree in Supply Chain, Business, or related field (MBA preferred)., • Minimum 7+ years of experience in sourcing/procurement within the beauty, cosmetics, skincare, or supplements industry., • Strong knowledge of manufacturing processes, private label, and contract manufacturing., • Familiarity with regulatory requirements (FDA, GMP, and cosmetic/supplement compliance)., • Proven experience in supplier negotiation and vendor management., • Strong analytical and problem-solving skills., • Excellent communication and relationship-building abilities., • Ability to thrive in a fast-paced, on-site environment. Nice to Have • International sourcing experience (Europe, Asia, etc.)., • Experience with ERP/procurement systems (NetSuite, SAP, Oracle)., • Knowledge of natural, organic, or clean beauty formulations and ingredients., • Experience in luxury or premium beauty brands., • Understanding of ingredient sourcing and product formulation fundamentals. Why Join Oliveda • Be part of the fastest growing waterless beauty movement, • Work in a category-defining, high-growth global brand, • Competitive compensation and performance-driven growth opportunities, • Job Details, • Job Type: Full-Time, on-site, • Location: Culver City, CA, • Salary Range: 95K – 125K (depending on your experience), • Benefits: Medical, Dental, Vision, Life & Health Insurance, plus 401(k), • Plus $250 worth of Olive Tree People products each month, along with a 50% discount on all products.

Radio Frequency Engineer – Beauty Industry Shape the Future of Waterless Beauty with Oliveda Waterless Beauty is the fastest growing sector in the entire beauty industry, and we are the fastest growing waterless beauty brand disrupting the industry. Oliveda is seeking an experienced Radio Frequency (RF) Engineer with a strong background in the beauty, skincare, or aesthetic devices industry. This role will support the development, testing, and optimization of innovative RF technologies used in advanced skincare and aesthetic treatments. What You Will Do • Design, develop, and optimize radio frequency systems and aesthetic devices, • Support product development from concept through production, • Conduct testing, troubleshooting, and performance analysis of RF equipment, • Ensure compliance with safety and regulatory standards, • Collaborate with R&D, Product Development, and Quality teams, • Provide technical expertise for beauty and skincare technologies, • Support training and technical guidance for internal teams What We Are Looking For • Bachelor’s degree in Electrical Engineering, Electronics Engineering, or related field, • Experience working with RF technologies and aesthetic/beauty devices, • Knowledge of skincare, beauty tech, or medical aesthetic equipment, • Strong understanding of RF systems, hardware, and testing methodologies, • Experience with regulatory standards and product compliance, • Excellent problem-solving and communication skills, • Ability to work in a fast-paced and innovative environment Nice to Have • Experience with skin tightening, anti-aging, or body contouring technologies, • Background in medical devices or cosmetic technology, • Familiarity with FDA, CE, or other regulatory requirements, • Experience working with emerging beauty technologies and product innovation Job Details • Job Type: Full-Time, On-site (Culver City, CA), • Compensation: $110,000 – $130,000 per year (commensurate with experience), • Benefits: Medical, Dental, Vision, Life & Health Insurance, plus 401(k), • Plus $250 worth of Olive Tree People products each month, along with a 50% discount on all products.

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. As we continue to grow as one QuidelOrtho we are seeking a Program Lead, Digital Informatics QMS Strategy. This Program Lead is responsible for developing, maintaining, and communicating QuidelOrtho' s Quality Management System strategy for Digital Informatics, Software as a Medical Device (SaMD), Artificial Intelligence (AI/ML), and Automation platforms as they pertain to in vitro diagnostic (IVD) products and associated services across all global markets. This role serves as the strategic quality authority for digitalenabled products, ensuring that regulatory, quality, and compliance expectations are proactively embedded into product lifecycle processes, digital delivery models, and organizational ways of working. This position will be onsite in Rochester, NY. Define and evolve the global QMS strategy for digital health technologies, including SaMD, AI/MLenabled systems, cloudbased platforms, and automated workflows. Interpret and operationalize global regulatory and standards requirements (e.g., FDA, EU MDR/IVDR, ISO 13485, IEC 62304, ISO 62366, ISO 14971, GxP data integrity) as they apply to digital and informatics solutions. Partner with R&D, IT, Product Management, Regulatory Affairs, PMO, and Technical Quality to ensure quality by design is embedded throughout the digital product lifecycle. Establish governance models, procedural frameworks, and decision pathways that enable agile and scalable digital innovation while maintaining regulatory compliance. Lead riskbased approaches for software lifecycle management, cybersecurity, data governance, AI/ML change control, and algorithm performance monitoring. Serve as a thought leader and internal consultant on emerging regulatory expectations related to AI/ML, realworld data, automation, and digital transformation. Perform other work-related duties as assigned. Required: Bachelors and/or technical degree in Life Sciences, Pharmacy, Engineering, Computer Science, Biomedical Engineering or a related technical discipline. 8-10 years of progressively responsible experience within a regulated Quality Management System environment, with significant exposure to software, digital health, or informatics solutions. Demonstrated ability to lead QMS strategy development and influence senior stakeholders across complex, matrixed organizations. Strong understanding of global regulatory frameworks applicable to digital health, SaMD, AI/ML, and automated systems. Proven experience applying risk management, design controls, software lifecycle processes, and post market surveillance to digital products. Ability to translate regulatory and quality requirements into practical, scalable processes that support innovation. Bias toward action, with a track record of driving execution aligned to organizational strategy. Excellent written and verbal communication skills, including the ability to represent quality positions to executive leadership. Strong collaboration skills and the ability to operate effectively across technical, regulatory, and business functions. Willingness and ability to travel approximately 10-15%. Preferred: Advanced degree (MS, PhD, or PharmD) strongly preferred. Experience with AI/ML governance, algorithm change management, or real-world performance monitoring. Background in cloudbased systems, cybersecurity, data integrity, or regulated automation platforms. Experience supporting global regulatory inspections involving software or digital health products. Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally. External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers. The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. No strenuous physical activity. Standard activities include sitting, standing, walking, talking, hearing, and visual work. May include occasional travel for site visits, leadership meetings, or regulatory support. At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: Thrive Together - Collaborate intentionally, grow as a team Make It Happen - Focus on priorities, embrace continuous improvement Commit to Service - Cultivate a service mindset Embrace Inclusion - Be open and authentic, welcome diverse perspectives Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $155,000 to $202,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at _. #LI-SP1

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Senior IT GxP Systems Specialist position will manage day-to-day system administration, user support and implementation of GxP computerized systems for laboratories, manufacturing and other regulatory operations. In close partnership with R&D, Quality Control, Engineering and Manufacturing functional leads, the position will provide technical leadership for new system deployments, upgrades, and maintenance of GxP systems including networked and non-networked stand-alone equipment at multiple ImmunityBio sites. Essential Functions • Responsible for implementing and maintaining software supporting GxP laboratory equipment., • Responsible for daily GxP system operations, maintenance, and support., • Create and maintain system documentation, specifications, IT administrative and security SOPs and execute test scripts related to GxP systems to support Computer System Validation Systems Validation (CSV)., • Follow IT and Quality processes to maintain systems in a validated state and ensure GxP systems are in compliance with 21 CFR part 11., • Manage incident tickets, perform troubleshooting and periodic assessments of systems., • Evaluate and assign appropriate data security, user roles and privileges for data integrity., • Coordinate with system vendors and business partners in various functions to schedule upgrades, maintenance, and support activities., • Flexibility to provide 24 x 7 IT support for operations., • Create and maintain service catalog related to IT GxP operations., • Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs. Education & Experience • Bachelor's degree in Information Technology, Computer Science, Engineering, or a related field with 4+ years of hands-on Systems Administration experience supporting end-users, servers, applications, storage, and networking in a pharmaceutical or related industry is required; OR, • High School Diploma or equivalent with 8+ years of hands-on Systems Administration experience supporting end-users, servers, applications, storage, and networking in a pharmaceutical or related industry is required., • 1+ years of providing IT support in a GxP environment is preferred. Knowledge, Skills, & Abilities • Strong understanding of Windows operating systems, networking protocols (TCP/IP, DNS, DHCP), VLANs, wireless access points, IP addresses, group policies, and user/group management security., • Working knowledge of FDA cGMP and cGLP regulations including 21 CFR Part 11., • Strong experience in customer service, incident management, and problem management., • Strong technical, analytical, and business acumen with excellent attention to detail., • Strong interpersonal and communication skills, • Strong troubleshooting and problem-solving skills, with the ability to learn and adapt to new technologies and processes quickly., • Ability to manage multiple projects simultaneously while performing day-to-day activities., • Ability to present technical information to management, employees, and other departments., • Excellent interpersonal, written and verbal communication skills., • Excellent ability to write, review, edit, and approve technical documentation., • Ability to pivot and work well in complex, fast-paced environments., • Strong leadership and influence skills with demonstrated business partnering approach., • Proactive and self-motivated team player with exceptional organization, follow-through, time management, and communication skills., • Proven ability to work collaboratively in a matrix organization. Working Environment / Physical Environment • This position will be onsite., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • Participate in On-Call rotation for after-hours support and may work outside of established shift hours upon short notice to address any emergencies, • Exposure to onsite in-lab environment, • Must be able to don and wear Personal Protective Equipment (PPE) as required, • Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer., • Lift and carry materials weighing up to 20 pounds. This position is eligible for a discretionary bonus and equity award. The hourly base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $54.52 (entry-level qualifications) to $60.57 (highly experienced) per hour The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Value Stream Quality Manager will be responsible for oversight of the product lifecycle of ImmunityBio's products from a quality perspective. To meet the demands of a multi-product clinical phase bio-pharmaceutical company that is transitioning from clinical to commercial phase with several products, this position works cross-functionally with Process Sciences, Manufacturing, Quality Control and Regulatory Affairs and will support the product lifecycle from new product introduction to commercialization ensuring that products meet established quality standards, are fit for purpose, and align with regulatory and organization expectations. This role will support GMP production activities, both internally at ImmunityBio and at external parters or CMOs (Contract Manufacturing Organizations), for both clinical and commercial products by developing and implementing quality control processes, analyzing data to identify issues, collaborating with cross-functional teams, and driving continuous improvement initiatives to maintain phase appropriate compliance to regulations. Essential Functions • Deploy Lean, Six Sigma methodology and tools to manage the value stream flow of ImmunityBio's product to customers., • Manage product lifecycle from end to end to ensure compliance with global GMP requirements for ImmunityBio products portfolio., • Own, lead and/or manage quality programs supporting Value Stream Quality activities and responsibilities., • Identify continuous improvement activities and implement changes to enhance the overall Value Stream Quality management and oversight of product lifecycle., • Ensure adherence to global industry regulations and quality standards., • Lead the strategic quality planning process for new product introduction, lifecycle phase transitions and major product change controls for process and specifications., • Provide quality oversight for product-related risk assessments, deviations and CAPAs. Provide product impact assessments and reviews/approves ImmunityBio deviations related to internal/external products., • Review and approve product specifications and product related protocols and reports for internal and external programs., • Collaborate with internal and external partners to meet the needs of the organization in a compliant manner., • Review external program investigations with cross-function team ensuring robust investigation and product impact assessment, appropriate root cause identification and implementation of appropriate corrective and preventative actions., • Develop and foster positive relationships with CMO Quality and Manufacturing partners and hold them accountable to business needs, • Participate in CMO team meetings and escalate quality and compliance issues to Senior Leadership Teams at ImmunityBio., • Participate in internal and external site audits and serves as Quality Person-In-Plant, as assigned., • Support preparation for internal and external regulatory agency inspections and participate as a subject matter expert during regulatory GMP inspections., • Maintain compliance with all assigned training requirements and train others as assigned., • Create, draft and/or revise SOPs, work Instructions, and other controlled document types, as assigned., • Perform ad-hoc and cross-functional duties and/or projects to support business needs and provide developmental opportunities. Education & Experience • Bachelor's degree in engineering, biological science, chemistry, or related science field is required., • 7+ years of experience in the clinical and/or commercial pharmaceutical / biopharmaceutical industry is required., • Minimum 5 years of direct experience in Quality Assurance / Quality Control is required., • Advanced understanding of and experience working with quality management systems and across all phases of the product lifecycle (early phase through commercial) is required., • Experience working with Contract Manufacturing Organizations (CMOs) is required., • Experience in supporting both internal and external regulatory inspections (e.g. FDA, EMA, MHRA) is preferred., • Lean, Six Sigma Greenbelt experience. Certification is preferred. Knowledge, Skills, & Abilities • Demonstrated knowledge of biologics cGMP manufacturing including recombinant protein and cell therapy cGMP manufacturing., • Strong knowledge of biologics cGMP aseptic manufacturing (required), including recombinant protein and cell therapy (preferred)., • Advanced knowledge of relevant regulations and regulatory guidance required to act as a resource for colleagues and team members., • Able to prepare written communications with clarity and accuracy. Must have strong authorship and be able to critically review batch production documents, interpret results, evaluate product impact, and generate technical conclusions consistent with Quality risk management principles., • Able to utilize strong problem solving and analytical skills to make detailed oriented decisions independently with limited supervision., • Demonstrated ability to effectively communicate (written and verbal) and interface with leadership, peers and cross-functional team members., • Able to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines., • Able to operate in a fast-paced, multi-disciplinary industrial environment and while managing multiple priorities., • Able to respond to challenges and additional projects in an understanding, positive, and objective manner; adaptable to dynamic conditions, and project timelines., • Must be proficient in Microsoft Office (Excel, Word, Power Point, Visio) and Adobe Professional software. Working Environment / Physical Environment • This position works on-site in El Segundo, • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • Flexibility in working schedule, i.e., off-hours, second shift, and weekends., • Ability to gown and gain entry to manufacturing areas., • Exposure to onsite in-lab environment., • Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer., • Lift and carry materials weighing up to 20 pounds. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $155,000 (entry-level qualifications) to $170,500 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

The Director, Medical Affairs (Nutrition) is responsible for leading and managing medical affairs for approved nutrition products and those in development. Areas of support include Product pre-launch and launch activities, Product Development, Product Lifecycle management, Business Development, and Post-Marketing medical affairs strategies. Collaborates cross-functionally and globally to ensure corporate goals and objectives are met at the highest levels. Directs the Region's medical needs for support of drugs and devices on the market, in development, and under evaluation. Responsible for cultivating and maintaining external relationships esp. with Health Care Providers (HCPs) and/or Health Care Decision Makers (HCDMs) to enable comprehensive scientific exchange around disease states and associated Company products. Must maintain scientific expertise in the application of treatment guidelines and clinical data as it pertains to disease states and associated Company products. Must be able to communicate complex medical and scientific concepts to a broad range of audiences. The Director, Medical Affairs, will also support execution of Medical Affairs strategy and activities where and as appropriate. The Director, Medical Affairs will lead the field clinical education team and ensure that the respective territory engagement plans are effectively executed per defined targets, following Fresenius Kabi compliance rules and code of conduct and that relevant medical and scientific insight is routinely shared to optimize the Medical Affairs strategy for the nutrition portfolio. *Priority will be given to candidates in the Chicagoland area who are able to regularly work at our Lake Zurich, IL site. *This position does not offer visa sponsorship either now or in the future. • Salary Range: $185,000-220,000., • Position is eligible to participate in an annual bonus plan with a target of 16% of the base salary., • Position is eligible to participate in our medium-term incentive plan., • Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities., • Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage., • Lead the strategic planning, launch, and lifecycle support of nutrition products including high-risk medications., • Lead the development and execution of medical affairs strategy to support successful product launch ensuring alignment with commercial, clinical development, regulatory teams and internal stakeholders., • Maintain the highest levels of professional integrity & performance standards by consistently providing high quality medical deliverables on time. Maintains a high standard for medical and scientific accuracy, representative of a comprehensive understanding of the medical concept at hand. Maintains a high level of professional expertise by staying abreast of current medical landscape with regard to key clinical conditions our products support., • Identify, engage, and build strong relationships with Key Opinion Leaders (KOLs), influencers in HCP community, scientific experts, and medical societies to support scientific exchange and advocacy., • Lead the nutrition team ensuring achievement of compliant and effective healthcare professional interaction for scientific exchange related to disease states and/or associated Company products per predefined engagement plans and targets., • Establish and maintain relationships with HCPs and HCDMs to provide scientific exchange related to disease states and/or associated Company products., • Represent the company at major medical and scientific conferences; manage planning and coordination of congress activities, including symposia, medical affairs booth presence, and thought leader engagements., • Oversee publication planning and execution, including abstracts, posters, manuscripts, and scientific communications, ensuring timely and compliant dissemination of clinical data., • Drive medical education initiatives for internal and external stakeholders, including training programs, advisory boards, and peer-to-peer education aligned with the product's scientific platform., • Provide scientific leadership and oversight for Investigator-Initiated Trials (IITs), including review, approval, and ongoing collaboration with investigators., • Collaborate cross-functionally to design and implement company-sponsored clinical studies to support product differentiation, real-world evidence generation, cost-effectiveness analysis, HEOR studies and post-marketing commitments., • Lead and manage a team of medical affairs professionals; provide coaching, development, and performance management to ensure high team effectiveness., • Collaborate with Global Medical Affairs in the support of USA-based clinical trials, both internal and external., • Review, develop, and approve clinical summaries in support of NDA 505(b)(2), ANDA, NDA applications., • Serve as a medical expert for on market parenteral nutrition products, products in development, and potential acquisition targets providing medical affairs strategies and due diligence for on market products and business development opportunities., • Responsible for writing and/or review of relevant Standard Operating Procedures (SOPs) pertaining to the role as needed. Job Requirements: • Medical/clinical professional degree required, such as Licensed Registered Dietitian., • Clinical Nutrition knowledge is required., • 10+ years of experience in the pharmaceutical industry in a medical affairs or clinical development role required., • 3+ years of hands-on experience in patient care and in hospital and/or clinic and/or home infusion settings is required, with demonstrated expertise in clinical nutrition including experience in managing formula selection for oral nutritional supplement use and tube feeding regimens., • 5+ years of clinical experience preferred., • 5+ years of direct people management experience with demonstrated ability to develop and lead high-performing teams., • Ability to understand and interpret the regulatory requirements under which drugs and devices are developed, reviewed, and supported after approval., • Experience with the clinical drug development process and product launch experience is highly preferred., • Scientific research and writing skills required. Ability to critically evaluate the published medical and scientific literature and approve and write comprehensive, medically accurate and scientifically fair-balanced documents., • Position will require travel (20-50%), including overnight stays. A valid US driver's license and clean driving record are required., • Ability to understand and interpret FDA 505(b)2, 505(b)1, 505 (j) submission requirements., • Knowledge of PC systems and Microsoft Office Suite (Word, Excel) is required. We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Supervisor, Facilities Maintenance will supervise and direct the facilities maintenance, calibration and metrology team; and manage the maintenance, preventive/corrective maintenance and upkeep of manufacturing and production assets for multiple locations. The role will participate in cross functional teams to ensure ImmunityBio's expectations and standards are maintained. Essential Functions • Oversee and ensure all locations are maintained up to GMP standards and make recommendations for improving the maintenance, calibration, and safe use of equipment at multiple sites., • Lead, coach, train and evaluate the performance of team members while directing the maintenance and calibration of facilities assets at multiple locations. Establish work schedules for the maintenance, metrology and calibration team., • Interface with Senior Leadership and other stakeholders to plan and coordinate facilities preventative and corrective maintenance and provide progress reporting documents and briefing as required., • Liaise with and oversee contractors' performance and take action to ensure compliance with all company standards and maintenance and calibration requirements, including sanitation, safety, quality, scheduling, productivity and budget. Ensure compliance with all required permits., • Oversee, lead and perform preventive and corrective maintenance of critical plant equipment on a regular basis, to include, but not limited to, Manufacturing, Filling, Sterilization Equipment and electrical control systems as responsibility assigned to Manufacturing Maintenance in both cGMP and non-cGMP areas., • Lead and delegate repairs and replacement of mechanical, electrical and controls components of Manufacturing, Sterilization and Packaging Equipment., • Develop strategic plans for facility equipment maintenance, upgrades and acquisitions inclusive of participating in budgeting, cost estimation, and procurement processes., • Collaborate with architects, contractors, and vendors on facility projects as needed., • Troubleshoot, diagnose, and repair critical equipment including but not limited to plant equipment, filtration systems, centripetal equipment, pumps, sterilization, filling packaging equipment and electrical controls to include, but not limited to, indicators, electrical distribution, variable frequency drives, electric motors and electrical control systems., • Prepare maintenance reports, detail and document work order status., • Prepare metrics reports, for facilities calibrations and metrology KPI., • Lead engineering projects including but not limited to equipment installation, commissioning, and validation process. Ability to assist within the engineering group in equipment failure root cause analysis with prompt resolution., • Create, maintain and adhere to Standard Operational Procedures (SOP), work plans, maintenance data templates, and drawing redlines as necessary., • Oversee the maintenance of measurement data for the Measurement Data Template (MDT) and maintain metrics for reporting., • Maintain documents in VEEVA., • Ensure workplan templates are generated within computerized maintenance management system (CMMS) and resolves problems proactively as needed. Mentor and train new and junior team members., • Lead and attend required training and meetings. Maintains training records for the team., • Lead and participate in audits and regulatory inspections., • Perform and delegate other special projects and duties as assigned. Education & Experience • Bachelor's degree in Engineering, Facilities Management, or a related field with 7+ years of Process GMP, Mechanical experience required; or, • 8+ years of Process GMP, Mechanical experience with a Maintenance Certificate or Utilities Certificate required; or, • High School Diploma with 10+ years of Process GMP, Mechanical experience required., • 5+ years working experience of Computerized Maintenance Management Systems (CMMS) required., • 3+ years' experience working in an FDA regulated environment required., • Experience with and working knowledge of facilities equipment and preventive maintenance programs required., • Critical Utility Systems (WFI, PUW, HVAC, waste neutralization, electrical generators, process utilities, etc.) required, • Supervisory and/or budget management experience preferred., • Experience in a Pharma-Biotech manufacturing environment strongly preferred. Knowledge, Skills, & Abilities • Self-starter with the ability to work with minimum supervision., • Excellent Instrumentation and mechanical skills and knowledge of maintenance principles., • Ability to work in a fast-paced environment and maintain a high level of customer service., • Hands-on execution of maintenance of process equipment, utility equipment, and facilities, • Working knowledge of cGMPs, OSHA compliance, HVAC systems and cleanrooms, automated pharmaceutical processing and plant equipment., • Follow and comply with EPA, OSHA, and NFPA regulations and with SOPs and cGMP policies., • Ability to troubleshoot, diagnose, and repair of critical equipment including but not limited to:, • plant equipment, filtration systems, centripetal equipment, pumps, sterilization, filling packaging equipment and electrical controls to include, but not limited to, indicators, electrical distribution, variable frequency drives, electric motors and electrical control systems., • Excellent written and verbal communication skills to effectively convey information in face-to-face and in group settings., • Excellent teamwork and cooperation skills., • Ability to lead a team and navigate the team through complex situations., • Ability to understand and comprehend oral and written instructions., • Able to work independently and make sound judgments regarding safety, work methods and tools, • Ability to multi-task and exercise good judgment., • Proficient at understanding and writing reports and work instructions., • Ability to understand the advanced process and control theory of a Critical or Major system., • Able to demonstrate and maintain a positive attitude even during challenging tasks., • Ability to verify mechanical and electrical drawings for accuracy as well as read wiring diagrams, blueprints and P&ID drawings., • Able to understand and perform analog, digital, frequency, and time calibration of electronic systems and components. Working Environment / Physical Environment • This position works on-site., • Local travel required between ImmunityBio sites., • Exposure to onsite in-lab environment., • Must be able to don and wear Personal Protective Equipment (PPE) as required., • Available to work off hours (weekends, holidays, after hours) to support company objectives., • Ability to work in a standing position for long periods of time (up to 8 hours)., • Lifting, standing, climbing, bending, grasping, sitting, pulling, pushing, stooping, stretching, and carrying are generally required to perform the functions of this position., • Must be able to frequently lift up to 35 pounds and occasionally lift/move 50 pounds. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $126,000 (entry-level qualifications) to $140,000 (highly experienced) annually OR The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Senior Medical Writer will be responsible for the preparation of high-quality regulatory documents, including clinical study reports, clinical summaries and overviews, study protocols, Investigator's brochures, and informed consent forms. The Senior Medical Writer will also be responsible for more complex writing assignments and will serve as subject matter expert within the department. The Senior Medical Writer may also be responsible for planning, managing, and preparing internal and external communications of key scientific and clinical data, including abstracts, poster and oral presentations, manuscripts, congress materials, and educational/training materials. Essential Functions • Serve as medical writing lead on more complex writing assignments. Work closely with in-function and cross-functional team(s) on document strategies. Implement all activities related to the preparation of writing projects., • Serve as a subject matter expert within department for assigned therapeutic/product areas., • Mentor less experienced medical writers on complex projects, as necessary., • Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate., • Write, edit, and finalize CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents., • Write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documents., • Write effectively for diverse audiences, including scientists, physicians, payers, regulators, and patients., • Work collaboratively with other functional groups (eg, Regulatory Operations, Biometrics, Clinical Operations) to gather source data, and prepare and finalize regulatory documents., • Lead project team meetings and document review meetings., • Provide direction and solutions to cross-functional teams on expectations for document content., • Perform QC of clinical and nonclinical documents., • Provide documents that are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelines., • Perform other duties as assigned. Education & Experience • A bachelor's degree in science-related fields with 4+ years of relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, publications, clinical research, or product support/R&D experience is required; Or, • A master's degree in science-related fields with 2+ years of relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, publications, clinical research, or product support/R&D experience is required., • Experience in NDA submissions and writing CSRs, IBs, clinical study protocols and other documents for regulatory submissions is required., • Strong scientific background in oncology, immunotherapy, or related field is required. Knowledge, Skills, & Abilities • Proficient knowledge of AMA writing guidelines., • Excellent verbal and written communication skills in English., • Extensive knowledge of FDA, EMA, and ICH guidelines., • Deep understanding of the drug development process and prior experience in the biopharmaceutical industry., • Ability to demonstrate familiarity with principles of clinical research and to interpret and present clinical data and other complex information., • Excellent time- and project-management skills, attention to detail, and ability to balance multiple projects simultaneously., • Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution., • Ability to work collaboratively in a dynamic environment., • Highly proficient in MS Project, MS Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, EndNote, and eCTD authoring templates. Working Environment / Physical Environment • The position works either onsite in El Segundo, CA; Torrey Pines, CA; or remotely depending on the candidate's geographic location., • Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval, • Lift and carry materials weighing up to 20 pounds. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. National Market (all markets unless identified as Premium) $115,500 (entry-level qualifications) to $127,000 (highly experienced) annually Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston) $122,700 (entry-level qualifications) to $135,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Senior GCP Auditor ensures GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This position interacts cross-functionally with functional teams in Clinical Trials which include Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing and Data Management to ensure compliance to the GCP Quality Management System and all applicable regulatory requirements. This role is responsible for maintaining inspection readiness at all times. Essential Functions • Maintain and update the Clinical Trial Quality Management system to be current with industry standards, guidance, and best practices., • Contributes to the development and review of SOPs and other controlled documents (forms, templates, work instructions)., • Ensures compliance with SOPs and ICH GCP E6 (R2) standards., • Manages the incident management program through monitoring of complaints, deviations and CAPAs. • Schedules, plans, coordinates, and conducts vendor/supplier audits, internal audits, compliance visits, for cause audits and clinical trial site audits., • Prepares required documentation to support audit activities including audit plans, audit reports, audit certificates and corrective action plans, • Validates accuracy of audit findings, a written audit report and follow-up activities to assure that non-compliance issues are addressed with satisfactory resolution., • Reviews the final audit documents for accuracy., • Review trial related documents e.g. protocols, protocol amendments, ICFs, pharmacy manuals and CSRs, • Apply regulations, guidance document requirements, and study protocol requirements to clinical trial studies., • Participate in solving GCP compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance., • Support joint efforts in training on company procedures, GCP regulations, and documentation systems to assure compliance with company policies and regulatory standards., • Maintain all associated QA department spreadsheets tracking of deviations, CAPAs, complaints, audit findings, and audit files as applicable., • Lead development and implementation efforts for inspection readiness at all times., • Assists senior staff during regulatory inspections or other audits., • Represents QA department at internal and external meetings supporting clinical programs., • Performs other Quality related duties, as assigned. Education & Experience • Bachelor's Degree in a life sciences or engineering discipline with a minimum of 7 years of experience in a GCP-Biologics or Pharmaceutical environment; or Master's degree in a life sciences or engineering discipline with a minimum of 4 years of experience in a GCP-Biologics or Pharmaceutical environment, • CQA or other audit certifications are a plus, • Prior TMF or electronic document management systems experience is a plus Knowledge, Skills, & Abilities • Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines, • Strong problem solving and analytical skills with demonstrated ability to be detail-oriented, while managing multiple projects simultaneously., • Demonstrated understanding and application of ICH GCP E6 (R2), • Proficient in communication both verbal and written, • Multitasks across multiple functional areas, • Timeline focused and flexible in their work scheduling to meet the demands of a multi-product clinical phase pharmaceutical company. Working Environment / Physical Environment • This position works remote, • Flexibility in working schedule, i.e., off-hours, second shift, weekends, • 25%-30% travel may be required This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. National Market (all markets unless identified as Premium) $140,000 (entry-level qualifications) to $154,000 (highly experienced) annually Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston) $145,500 (entry-level qualifications) to $160,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Senior Associate, Quality Control Microbiology will support the facility environmental and utility monitoring (EM) programs in support of sterile product manufacturing, to include sampling, testing, and data management of the collected samples, training personnel on aseptic technique and aseptic gowning, complete investigations, and support lab operations such as equipment preventive maintenance, supply inventory management, and general support tasks in order to allow the lab to continuously operate. The position will also provide leadership and guidance to junior analysts, support method/SOP revisions, study protocols, method transfers, and qualifications. The incumbent may also support lab assays for lot release and stability testing, participate in sample preparation and aliquoting, media lot release testing. Essential Functions • Organize daily workload schedule and relevant resource requirements., • Participate in authoring complex, explicit documentation for manufacturing operations., • Environmental and Critical Systems monitoring, testing, review, reporting, and trending. Reviewing of data, trending, and applicable investigations., • Support all compliance aspect related to microbiological and analytical testing and will support investigations and root cause analysis., • Play a critical role in working collaboratively with manufacturing technicians and associates in support of EM., • Routine and validation sample testing under GMP or non-GMP modes, laboratory maintenance, and assist in method or equipment qualification/validations., • Responsible for laboratory maintenance to include cleaning and sanitization of laboratory equipment, laboratory restocking of supplies and inventory., • Coordinate and generate Risk Assessments., • Assist with the drafting of controlled documents including Protocols, Reports, SOPs, Test Methods, Specifications and Work Instructions, data entry and reporting, • Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's degree in a life sciences discipline with 2+ years of experience in a GMP regulated Biologics or Pharmaceutical environment required, • Experience in cGMP aseptic processing facility is a plus Knowledge, Skills, & Abilities • Knowledge of regulatory expectations for QC Microbiology department, • Knowledge of environmental and critical utilities monitoring, personnel monitoring, aseptic processing, and microbiological testing assays., • Fundamental knowledge of microbiology (knowledge of cell and molecular biology, immunology, and virology is a plus)., • Strong technical writing skills with experience preparing: SOPs, analytical tests reports, work instructions, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings., • Strong problem-solving skills with demonstrated attention to detail., • Good understanding and demonstration of aseptic techniques., • Proficient in Microsoft Word, Project, and Excel, • Ability to perform troubleshooting and develop solutions to problems of moderate scope in complexity., • Strong verbal, written, and interpersonal communication skills., • Proficiency in computer use and Microsoft Office applications., • Proven ability to work independently and analyze and resolve issues that impact quality., • Attention to detail with strong analytical and problem solving skills., • Well-developed written and oral communication skills; motivated to work in a team environment., • Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple priorities., • Exceptional organization and time-management skills. Ability to deliver under deadlines., • Ability to multi-task and retain flexibility in a dynamic environment., • Consistently deliver on commitments Working Environment / Physical Environment • This role will work onsite in El Segundo, CA, • Flexibility in working schedule, i.e., off-hours, second shift, and occasional weekends and holidays to meet business needs, • Ability to gown into cleanroom for extended period of time, • Exposure to onsite in-lab environment, • Travel approximately 10% This position is eligible for a discretionary bonus and equity award. The hourly base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $37.50 (entry-level qualifications) to $41.25 (highly experienced) per hour The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Field Medical Director (FMD) is a field-facing representative of the Medical Affairs Department with a primary responsibility to engage in the exchange of scientific data and education of health care practitioners on ImmunityBio products and relevant disease states, and facilitation of clinical research. The FMD integrates clinical/scientific expertise and knowledge to ensure successful implementation of the medical affairs strategic plan within an assigned geographic region. The FMD brings relevant insights from the field on research developments, treatment landscape and new concepts in medical treatment. The role of the FMD is non- promotional in nature. Essential Functions Product/Therapeutic Area Support to External Stakeholders • Act as the primary clinical/scientific resource to Key Opinion Leaders (KOLs) and Health Care Practitioners (HCPs) in a specified geography for information pertaining to disease state and ImmunityBio's product(s) and pipeline to ensure awareness and understanding., • Serve as a conduit for accurate and updated clinical, scientific, and medical information between KOLs, investigators and the company's Medical Affairs and Clinical Development groups., • Establish, foster, cultivate and maintain peer relationships with KOLs and HCPs in the therapeutic areas in which ImmunityBio has current and future interests., • Share knowledge and participate in scientific exchanges and interactions with identified KOLs, • Delivers timely, accurate, and succinct clinical and scientific presentations to KOLs and HCPs, both proactively and in response to requests for information, consistent with promotional compliance, PhRMA guidelines, and FDA regulatory requirements., • Identify and report key scientific, clinical and research insights from KOLsand HCPs to Medical Affairs for communication to key internal stakeholders., • Respond to unsolicited medical information requests in the field., • Fulfill harmacovigilance responsibilities defined by ImmunityBio SOPs related to medical inquiries and drug safety information., • In collaboration with manager, develop and implement the medical territory plan within geography., • Lead special projects such as development of training materials, training MSLs, mentoring MSLs, development of advisory board materials, facilitation and/or moderation of advisory boards, etc. Training/Education • Develop, maintain, and demonstrate scientific expertise and a strong knowledge of oncology and disease states of interest to ImmunityBio, including the competitive landscape, ImmunityBio products and pipeline, clinical practice, and study methodology., • Demonstrate full knowledge of, and ability to execute on, approved medical strategies and MSL initiatives., • Serve as scientific subject matter resource to ImmunityBio commercial personnel and other internal stakeholders, as requested. Research Support • In collaboration with Medical Affairs personnel, support data generation via Investigator- Initiated Trials (IITs), external collaborations, and HCP-initiated projects., • Facilitate the review and follow-up of submitted research proposals., • Support Clinical Development/Operations with ImmunityBio corporate-sponsored trials as requested/assigned e.g., provide recommendations for site selection, present clinical data at site initiation, training, or investigator meetings, communicate insights from clinical sites internally to Medical Affairs and Clinical Development / Operations. Professional Organization Support • In collaboration with internal ImmunityBio colleagues, support relationship development and interactions with professional organizations/societies & advocacy groups, GPOs, and large networked practices., • Collaborate with internal colleagues and HCPs on Medical Affairs initiatives including publications as requested, advisory boards, medical meeting support, medical education opportunities, training, speaker development, etc. Health Economics and Outcomes Experience: • Develop relationships with KOLs as identified by Medical Affairs in collaboration with Market Access., • Identification of treatment pathways at key clinical sites., • Identification, internal communication, and execution of opportunities for evidence generation., • When assigned, deliver scientific and value presentations to health care decision makers (HCDMs), including, but not limited to, Managed Care Organizations (MCOs), specialty pharmacy providers (SPPs), group purchasing organizations (GPOs), pharmaceutical benefit managers (PBMs), and integrated delivery networks (IDNs). Education & Experience • Advanced medical/scientific/clinical degree (MD, DO, PhD, PharmD, NP, and PA preferred) with experience in the pharmaceutical industry or related healthcare field required., • A terminal doctoral degree (e.g., MD, PharmD or PhD) in medical or health sciences or equivalent is strongly preferred., • A minimum of 8 years of relevant therapeutic area expertise, in a scientific or clinical setting, in oncology, immunology, or other areas relevant to ImmunityBio's products and/or pipeline required., • A minimum of 5 years of experience as a clinical/medical science liaison or related field- facing role, in the pharmaceutical or biotechnology industries is preferred. Experience in solid tumors is preferred and GU and Lung experience is strongly preferred., • Clinical trial experience is required., • Must possess and maintain a current valid driver's license. Knowledge, Skills, & Abilities • Knowledge of treatment guidelines, clinical research processes, FDA regulations and OIG guidelines are preferred., • Excellent interpersonal communication and presentation skills are required., • Ability to network and partner with important external customers, including medical thought leaders, academic institutions, large group practices, medical directors and pharmacy directors is required., • Demonstrated ability and experience working cross-functionally., • Demonstrated ability to anticipate, organize, plan, and handle multiple changing priorities., • Demonstrated ability to work independently., • Demonstrated proficiency in communication at all levels of an organization., • Demonstrated strong business acumen., • Ability to read, analyze and interpret scientific and technical information and data., • Individual should be able to apply critical thinking processes in order to optimize strategic initiatives and decision-making., • Requires operational proficiency with Power Point, Word and Excel., • Demonstrated ability to work with software tracking/logging systems, e.g., customer relationship management systems, insights capturing systems, etc., • Committed to the concept of team and working within the framework of the Medical Affairs Department, including as it pertains to compliance with policies, systems, and practices. Working Environment / Physical Environment • This a field-based position. The employee is required to set up a home-based office., • Capable of engaging in frequent business travel (approximately 50% of the time) including automobile, train, and air travel and ability to travel overnight and occasionally on weekends., • Domestic and international travel may include spending time at cancer trial sites/institutions, conference center, offices, and hotels., • FMD must live in the assigned territory., • Requires driving a personal vehicle on behalf of the Company, • Must successfully complete a motor vehicle record check upon hire and annually thereafter, • Must maintain a standard form of automobile liability insurance that meets the company's required minimum coverage limits (currently $250,000/$500,000 bodily injury liability and $100,000 property damage liability),, • Must provide proof of insurance coverage that meets these requirements upon hire and annually thereafter This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. National Market (all markets unless identified as Premium) $214,000 (entry-level qualifications) to $235,000 (highly experienced) annually Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston) $223,000 (entry-level qualifications) to $245,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Senior Clinical Supply Operations Manager is responsible for overseeing & supporting all aspects of clinical supply planning and logistics in support of ImmunityBio's clinical programs. This position works collaboratively with Clinical Operations, Quality, CMC Program Management and Regulatory Affairs to gather key study information and utilize available systems to create clinical supply plans and coordinate with internal and external partners to supply the necessary clinical material. The role will work closely with the Clinical Packaging/Labeling supplier to initiate labeling, packaging and distribution orders to ensure the timely supply of clinical trial material to enrolled sites. Essential Functions • Participate in cross-functional Clinical Study Teams and document study assumptions e.g. drug product, number of subjects, enrollment, treatment schedule, etc.., • Develop, & Implement clinical supply and inventory plans and timelines, including clinical drug supply labeling, packaging, and distribution to the sites, • Manage the Clinical Labeling/Packaging CMO, including initiating the Order Management process and the day-to-day fulfillment of drug shipment requests to depots and sites, • Identify and communicate clinical drug supply risks to internal and external stakeholders as appropriate, • Manage review and approval of clinical supply documentation (i.e. clinical labels, master batch records, label proofs, purchase orders/quotes) in conjunction with IB stakeholders including Regulatory, Clinical Operations and Quality, • Broad understanding of clinical product stability data in support of approved shelf-life and temperature transport and storage conditions, • Manage the Clinical Inventory reporting and review process, including broad understanding of interactive response systems to manage inventory including the destruction of obsolete and expired clinical drug product, • Develop and Implement new strategies that have organizational impact that enhance overall efficiency of the department, • Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates., • Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's degree in Business, Supply Chain Management, Operations Management, Engineering or relevant discipline required, • 7+ years of business experience with a demonstrated knowledge of Clinical Supply Chain Management concepts and Best Demonstrated Practices required, experience with Global Clinical supply management preferred, • 7+ years in the pharmaceutical, biopharmaceutical, or biotechnology field with specific experience in Demand Planning, Supply Planning, and Inventory Management required, • 3+ years of knowledge of computer based Interactive Response System to manage inventory strongly preferred Knowledge, Skills, & Abilities • Must have the ability to work independently and also be an influential team member in a fast-paced, team-oriented, dynamic environment, • Strong problem-solving skills including analytical and critical thinking abilities as well as business and financial analysis, • Working knowledge of FDA and EMA regulations, as well as cGMP and ICH guidelines applicable to the development and production of investigational and commercial drug products, • Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines, • Proficient in Microsoft Suite (Excel, PowerPoint, Project, Visio, Word) Working Environment / Physical Environment • This position works on-site (El Segundo, CA), • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • 10% Travel required This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $160,000 (entry-level qualifications) to $176,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The QA Specialist, Quality Operations (QAO) role is an individual contributor that guides and supports the GMP material receipt and manufacturing process on the floor by providing Quality Assurance oversight. The position will be focused on day-to-day support of manufacturing operations, and quality review and disposition of documents associated with raw materials and manufactured products. Essential Functions • Review executed manufacturing batch records, analytical testing data, and certificates of analysis for accuracy, completeness, good documentation practices, and compliance to cGMP and company procedures in support of disposition of manufactured product. Document, manage and support issue resolution associated with batch review., • Perform inspection and release of incoming raw materials according to appropriate material specifications and standard operating procedures., • Perform Quality Assurance activities to support Manufacturing operations, including but not limited to product label issuance/reconciliation, batch record issuance, Starting Material (i.e. Cell Banks) Receipt, Release and Inventory Management, Logbook (i.e. Equipment Use, Facility Cleaning) Issuance and Management., • Perform Product Complaint Investigations to determine root cause and identify/implement related Corrective and Preventative Actions., • Initiate Quality Deviation and perform robust investigation to determine root cause and identify/implement related Corrective and Preventative Actions., • Initiate and Own Quality Change Control, complete associated implementation task assignments and provide supporting documentation for completion of change records., • Perform Manufacturing Floor Observations (including Practice vs. Procedures, Aseptic Technique and Media Fill Observations) to ensure inspection readiness., • Identify Continuous Improvement Activities and implement changes to enhance the overall Quality Systems, Procedures and Oversight of GMP Operations., • Support both Internal and External Compliance/Regulatory Audits., • Maintain compliance with all assigned training requirements and train others as assigned., • Create, Draft and/or revise SOPs, Work Instructions, and other controlled document types, as assigned., • Collaborate in cross-functional team meetings to resolve quality issues., • Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's degree in engineering, biological science, chemistry, or related science field with 5+ years of experience in the pharmaceutical / biopharmaceutical industry is required; OR, • Bachelor's degree in engineering, biological science, chemistry, or related science field with 4+ years of experience with ImmunityBio manufacturing organization required., • Experience of biologics cGMP manufacturing includes ideally recombinant protein and cell therapy cGMP manufacturing required., • Strong understanding of and experience working with quality management systems required., • 2+ years of direct experience in Quality Assurance / Quality Control preferred. Knowledge, Skills, & Abilities • Strong verbal, written, and interpersonal communication skills., • Proficiency in computer use and Microsoft Office applications., • Proven ability to work independently to analyze and resolve issues that impact quality., • Attention to detail with strong analytical and problem solving skills., • Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple priorities., • Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines., • Experience in supporting both internal and external regulatory inspections (i.e FDA, EU). Working Environment / Physical Environment • This position works on site., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • Must be able to work flexible hours to support manufacturing needs, sometimes including weekends and holidays., • Will occasionally be exposed to excessive noise, hazards, extreme temperatures, and outdoor work., • Must be able to gown under clean room conditions., • Will frequently perform indoor work by sitting at desk operating computer., • Exposure to onsite in-lab environment., • May occasionally reach outward, above shoulder, lift/carry 20 lbs or less, and push/pull 12 lbs or less., • Will occasionally stand, walk, bend, travel to other facilities. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $88,200 (entry-level qualifications) to $98,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Director, Commercial QCA is responsible for the design, planning, implementation, and operation control of quality control programs to ensure product reliability, quality, efficacy, and compliance to applicable state, federal, and country-specific regulations including cGMPs and internal standards for manufacturing, materials and finished products related to the commercial N-803 program and all other QCA programs that are advancing to the commercial stage.. Essential Functions • Ensure the compliant (in line with all relevant guidance), efficient operations of Quality Control Analytical by overseeing all laboratory testing (in house and outsourced In Process, Lot Release, and Stability)., • Transfer, review, and approve methods and documentation including product specifications; protocols, SOPs, reporting of testing, analytical method development and validation and stability studies., • Ownership and oversight of all assay trending programs, • Design and implement methods to increase efficiencies and productivity, and to improve knowledge of product safety, purity, efficacy, potency, and stability. Design and implement strategies to transfer methods into QCA groups., • Ensure QCA decisions align with Quality System, GMP and regulatory requirements., • Provide budgets for current and future operations including strategy and plans for laboratory relocations and new laboratory implementation., • Develop and mentor the Analytical Quality Control staff to perform at a commercial level of compliance., • Oversee the performance of designated staff. Responsibilities include interviewing, hiring and training employees, planning, assigning and directing work; appraising performance; rewarding and disciplining employees, addressing complaints and resolving problems., • Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's degree in biology, chemistry, or other scientific related field with 15 years of related quality experience with 8+ years at the management level required; or, • Master's degree in biology, chemistry, or other scientific related field with 10 years of related quality experience with 8+ years at the management level required; or, • Ph.D. in biology, chemistry, or other scientific related field with 8+ years of related quality experience with 8+ years at the management level required, • Extensive experience with assay qualification, validation, and transfer activities required, • Experience for a FDA PLI, Surveillance, or other inspection, with an acceptable outcome required, • Experience with a start-up pharmaceutical company preferred Knowledge, Skills, & Abilities • Thorough understanding of biologics manufacturing processes, including cell culture, purification, and analytical characterization techniques. Understanding of cell therapy processes is desirable, • Proven track record of successfully leading QC teams, driving quality initiatives, and managing regulatory inspections, • Strong organizational skills, attention to detail, and ability to prioritize and manage multiple projects simultaneously, • Excellent communication skills, with the ability to effectively interact with cross-functional teams, senior management, and external entities, • In-depth knowledge in analytical method development and validation, and statistical quality control., • In-depth knowledge of GMPs, SOPs and pharmaceutical regulations., • Ability to use sound scientific judgment in management of the facility and processes to prevent regulatory action., • Understanding of GMPs and an ability to interpret and enforce regulatory requirements., • Ability to communicate professionally, knowledgeably, and efficiently with a wide range of employees and with all internal and external customers, both in writing and verbally., • Ability to work with contractors and suppliers, ensuring compliance with company standards and contractor systems., • Ability to define problems, collect data, establish facts and draw valid conclusions., • Demonstrated track record in managing a staff and establishing a clear, strategic direction., • Ability to develop a high-morale organization with leaders, teams, and groups, and appropriately staff the QC department to meet business needs., • Ability to analyze and interpret complex, scientific documents, including problem solving., • Ability to multi-task and prioritize with excellent project management skills. Working Environment / Physical Environment • This role will work on site, • Flexibility in working schedule, i.e., off-hours, second shift and weekends as needed, • Performs work in the lab as needed to supervisor staff and oversee quality control programs, • Must be able to gown PPE as needed to enter lab settings This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $215,000 (entry-level qualifications) to $236,500 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Principal Investigator – Psychiatry Clinical Research 📍 Los Angeles, California Metric Bio is partnered with a leading clinical research site network to appoint an experienced Principal Investigator with a strong background in Psychiatry studies. This is an exciting opportunity to join a high-performing research organisation at the forefront of CNS and psychiatric clinical trials, supporting cutting-edge therapies across a diverse patient population in the Los Angeles area. The Opportunity As Principal Investigator, you will provide medical oversight across a broad portfolio of Psychiatry clinical studies, working alongside an established research infrastructure with dedicated coordinators, raters, and operational support teams. The organisation has built a strong reputation for delivering complex CNS trials and offers access to a robust patient database, advanced research capabilities, and long-term study pipelines with global sponsors. Key Responsibilities • Serve as Principal Investigator across Phase I–IV Psychiatry clinical trials, • Ensure patient safety, protocol compliance, and regulatory oversight, • Conduct psychiatric evaluations and study assessments, • Collaborate closely with sponsors, CROs, and internal research teams, • Support patient recruitment and retention strategies, • Maintain high-quality standards in line with GCP and FDA regulations, • Provide leadership and mentorship within the clinical research team Requirements • MD or DO, • Active and unrestricted California medical license, • Prior experience as a Principal Investigator or Sub-Investigator in clinical research, • Strong understanding of CNS/Psychiatry trials, • Experience working within industry-sponsored studies preferred, • Passion for advancing innovative mental health treatments through research Why Join? • Join one of the most respected and rapidly growing research site networks in the industry, • Strong pipeline of Psychiatry and CNS studies, • Dedicated operational and recruitment support, • Competitive compensation package, • Opportunity to contribute to breakthrough mental health therapies, • Collaborative, patient-centric research environment For a confidential discussion, please apply directly or contact - Oli Oldham - oli.oldham@metric-search.com for further information.

The Associate Director, Clinical Study Management, will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our California office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world class inhouse clinical study management. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. About You You are collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology. What You’ll Do • Team leader and builder, who manages clinical trial deliverables, timelines, and budgets per the Clinical Development and Operational Plans, • Works with minimal oversight from the Clinical Operations Senior Director or Director, in collaboration with Clinical Study Management teams and Clinical Research and Development functional teams, • Demonstrate broad understanding of therapeutic and clinical drug development expertise to influence study design and program-level decisions, • Provide direction to cross-functional study teams to ensure successful study execution Ensure that clinical studies are conducted following approved protocols, FDA Regulations, ICH-GCP, EMA, PMDA, other relevant regulations, directives, and guidelines, and company procedures and quality documents, • Oversee risk identification, assessment, and mitigation strategies to ensure patient safety and data integrity, • Responsible for the implementation of processes and systems that will facilitate inspection readiness throughout the lifecycle of the trial., • Oversee the preparation and maintenance of detailed clinical trial project timelines, • Manage ancillary (non CRO) vendor relationships and performance to ensure that clinical studies are completed following contract specifications of time, cost and quality., • Work with finance, legal, and external vendors to ensure the assigned studies are meeting the target milestones, • Provide regular updates on study progress to stakeholders (e.g., Clinical Operations, Project & Portfolio Management, Clinical Research), • Ensure that all study-related documents are accurate, complete, timely and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems., • Responsible for hiring, performance management, career development, and providing mentorship to Clinical Study Management personnel., • Contribute to initiatives and projects adding value to Eikon Therapeutics Qualifications • Minimum of 10 years of related experience with a Bachelor’s degree or 8 years and a post-graduate degree., • Experience leading large, global clinical trials, preferably in oncology, • In-depth knowledge of ICH-GCP, EMA guidelines and other relevant regulations and guidelines., • Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety., • Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams., • Experience with management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery., • High sense of accountability and urgency to prioritize deliverables., • Growth mindset and capable of working independently.

Job Title: Regulatory Affairs Specialist (FDA/Medical Device) Location: Torrance, CA Type: Full-time (On-site) Schedule: 9:00 AM - 6:00 PM (Offers flexibility in occasions for your needs to take care of your family members or academic commitment) Role Overview An established consulting firm in Torrance, serving a prestigious roster of international clients in the medical device and pharmaceutical sectors, are looking for a Regulatory Affairs Specialist who values precision, professionalism, and long-term career growth. This role requires high-level coordination between US regulatory bodies (FDA, EPA) and our client base. The ideal candidate is not just a scientist, but a disciplined professional who thrives in a structured, collaborative, and detail-oriented environment. Key Responsibilities • Regulatory Submission Management: Meticulously compile and organize technical documentation for 510(k), PMA, De Novo, and Annual Reports, ensuring zero errors in compliance., • Structured Reporting: Provide frequent, detailed status updates to management and clients; synthesize complex data into clear, formal business reports., • Client Liaison: Act as a respectful and professional representative when communicating with government agencies and corporate clients to facilitate product approvals., • Strategic Research: Conduct exhaustive research on FDA/EPA regulations to support senior consultants in developing market entry roadmaps., • Team Support: Assist in various administrative and operational tasks to support the team's success, demonstrating a "team-first" mentality. Professional Expectations (Cultural Fit) • Meticulous Attention to Detail: You double-check your work naturally and take pride in accuracy., • Respect for Protocol: You are comfortable working within established procedures and respect organizational hierarchy and decision-making processes., • Dedication: You possess a strong work ethic and a willingness to be flexible with your schedule when critical deadlines or client needs arise., • Professional Etiquette: You maintain a high level of formality and politeness in all written and verbal communications, suitable for interacting with executives and government officials. Qualifications • Education: Bachelor's degree in a STEM field (Biology, Chemistry, Bioengineering, etc.) is required., • Experience: Previous experience in a corporate or research environment; exposure to Medical Device/Pharma industries is a major plus., • Technical Skills: Advanced proficiency in Microsoft Office (formatting in Word/Excel must be impeccable); ability to digest complex scientific literature., • Attributes: Punctual, humble, and eager to learn from senior mentors. Compensation & Benefits Salary: Competitive Annual Salary (Based on experience). Bonuses: Annual Year-End Bonus + Monthly Performance Incentives. Benefits: Medical, Dental, and Vision insurance; 401(k) Retirement fund. The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs. At Staffmark, we connect hardworking people with great companies, creating opportunities that make a lasting impact. Staffmark is an equal opportunity employer. Allapplicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Staffmark offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Staffmark is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.

Job Title: Japanese Bilingual Regulatory Researcher Employment Type: Full-time Location: Torrance, CA Work Hours: 9:00 am - 6:00 pm Position Overview A specialized consulting firm facilitating the entry of major Japanese healthcare and medical corporations into the US market is looking for a researcher. The ideal candidate is someone who excels at reading complex texts, interpreting intent, and synthesizing information. While background in science is highly preferred, the non-STEM candidates with deep-dive research and professional writing skills are also considered. This is an opportunity to build a specialized career in International Regulatory Affairs. Key Responsibilities 1. Legislative Research & Interpretation (Reading & Logic) • Conduct extensive qualitative research on US regulations (FDA, EPA, CFR - Code of Federal Regulations) and administrative guidance., • Move beyond surface-level translation to interpret the intent and context of regulations, analyzing how they apply to client products (medical devices, pharmaceuticals, etc.)., • Monitor changes in US government policy and regulatory trends. 1. Strategic Reporting & Professional Writing (Synthesis & Output) • Synthesize complex regulatory information into clear, logical, and persuasive business reports in Japanese., • Draft strategic roadmaps for market entry, ensuring that language nuances align with Japanese business etiquette and decision-making styles., • Assist in drafting responses and applications to government agencies, utilizing precise English terminology. 1. Cross-Cultural Communication & Project Liaison • Act as a cultural liaison between US regulatory bodies and Japanese corporate clients., • Attend high-level client meetings to facilitate understanding, taking detailed minutes and ensuring that no nuance is lost in communication., • Coordinate project timelines and deliverables, ensuring smooth collaboration between international teams. Qualifications Required: • Education: Bachelor's degree or higher. (Science background preferred; however, candidates with liberal arts/humanities background are also welcome), • Bilingual Proficiency: English and Japanese., • Computer Skills: Proficiency in Microsoft Office (Word, Excel, PowerPoint). Preferred: • Master's or Doctoral degree (experience in thesis writing, qualitative research, and defending arguments is a strong plus)., • Experience in legal research, translation, publishing, paralegal work, or think-tanks., • A strong interest in learning about the medical/healthcare industry (training provided). Personal Attributes • Intellectual Curiosity: You enjoy learning new systems and untangling complex problems., • Detail-Oriented: You are meticulous with facts and wording., • Adaptable: You thrive in a boutique, family-oriented environment where roles can be dynamic. Compensation & Benefits • Salary: Competitive annual salary (Commensurate with education and research experience)., • Bonuses:, • Annual Year-End Bonus., • Monthly Incentive Bonus (Performance-based, separate from base salary)., • Career Growth: Annual Salary Review., • Insurance: Medical, Dental, Vision, and Workers' Compensation., • Retirement: 401(k) or similar retirement fund program., • Time Off: Paid Time Off (PTO), Sick Leave, and Paid Holidays., • Work-Life Balance: Accommodation on work schedule available in occasions for nursing, childcare, or academic commitments. The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs. At Staffmark, we connect hardworking people with great companies, creating opportunities that make a lasting impact. Staffmark is an equal opportunity employer. Allapplicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Staffmark offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Staffmark is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.

Japanese Bilingual FDA Research & Regulatory Consultant Employment Type: Full-time Work Hours: 09:00 am - 6:00 pm (Flexible arrangements available) Work Location: Torrance, CA Job Overview A consulting firm is seeking a dedicated and bilingual FDA Research Consultant to join their team. This role serves as a bridge between US regulatory bodies and Japanese clients. You will conduct in-depth research on US regulations (FDA, EPA) regarding medical devices and pharmaceuticals in English, and analyze this information to provide strategic consulting and professional reports in Japanese. The ideal candidate is a proactive professional with a background in science or engineering (i.e. biology, chemical, bioengineering) who understands Japanese business etiquette and can communicate effectively with major Japanese corporations, and American government agencies and universities. This is a great opportunity if you are interested in interested in consulting and marketing business. Essential Duties and Responsibilities include but not are limited to: 1. Regulatory Affairs & Submissions • Extract information through literature searches and technical data analysis to support and prepare critical regulatory documents, including 510(k), De Novo, Pre-submission, Annual Reports, PMA, IDE, BLA, and DMFs., • Serve as the primary point of contact for regulatory authorities (FDA, EPA, etc.) to support client product deployment in the US market., • Prepare, develop, and organize complete sets of documents for submission to government authorities, ensuring strict adherence to compliance standards. 1. Research, Strategy & Consulting • Initiate and conduct comprehensive research on applicable US regulations (FDA, EPA) using English resources, covering medical devices, pharmaceuticals, and related industries., • Analyze regulatory data to create high-quality consulting reports and presentation materials in professional Japanese, tailored for client decision-making., • Assist senior consultants in developing product launch strategies, development roadmaps, and commercialization master plans for complex accounts., • Perform local field research and business investigations to support client market entry and competitor analysis. 1. Project Management & Client Communication • Plan and schedule project milestones, coordinating closely with the Manager and client counterparts to ensure timely delivery., • Act as a cultural and communication bridge between the US and Japan, utilizing strong bilingual skills to navigate business differences and facilitate smooth operations., • Attend meetings with client companies and regulatory agents; prepare and translate meeting minutes and lead reporting sessions to clearly communicate complex regulatory concepts., • Perform other duties as assigned by Management to support the team's success. Qualifications • Education: Bachelor's degree or higher (4-year university)., • Technical Skills: Intermediate proficiency in Microsoft Office (Word, Excel, PowerPoint)., • Cultural Competency: Deep understanding of Japanese business customs and the ability to maintain professional correspondence with high-level stakeholders (major companies, government, academia). Personal Attributes • Professional & Positive: A hard-working individual with a positive attitude., • Team Player: Someone who thrives in a supportive, family-like office atmosphere., • Adaptable: Willing to take on various tasks as the company grows. Preferred: • Language: Japanese/English Bilingual. o Must be able to research and conduct interviews in English. o Must have superior Japanese writing skills for creating formal business reports. • Education: Master's or Doctoral degree in a STEM field (Science, Technology, Engineering, Math)., • Experience: Prior experience working in the medical device or pharmaceutical industry. Compensation & Benefits • Salary: Competitive annual salary based on education and experience., • Bonuses: o Annual Year-End Bonus. o Monthly Incentive Bonus (paid separately from base salary). o Salary Review: Once a year. • Visa Support: Green Card sponsorship will be considered for exceptional performers after a period of employment., • Insurance: Medical, Dental, and Vision insurance; Workers' Compensation., • Retirement: Retirement fund accumulation (401k or similar)., • Time Off: Paid Paid Time Off (PTO), Sick Leave, Paid Holidays., • Wellness: Health support and training programs. Work Environment & Flexibility • Flexibility: Arrangement of working hours in occasions of necessity such as childcare, nursing care, or academic commitments. The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs. At Staffmark, we connect hardworking people with great companies, creating opportunities that make a lasting impact. Staffmark is an equal opportunity employer. Allapplicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Staffmark offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Staffmark is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.

Job Title: Sanitation Manager Work Location: Los Angeles, CA Work Hours: 9:00PM - 6:00AM (3rd shift) FLSA: Exempt, Direct-Hire, Full-Time OVERVIEW: An establishedfood manufacturer in Los Angeles is seeking an experienced Sanitation Manager to oversee and standardize sanitation operations across four production facilities. This is a high-responsibility role overseeing a 20+ member sanitation team and ensuring consistency in sanitation quality, procedures, and compliance across all sites. The Sanitation Manager will work closely with on-site Supervisors and Leads at each facility to drive alignment and execution under a unified sanitation system. In this role, you will serve as the central owner of sanitation standardization, audit readiness, and food safety compliance across a multi-site manufacturing operation. The ideal candidate is a hands-on leader with strong experience in USDA/FDA-regulated environments, capable of leading multiple teams while maintaining strict regulatory and operational standards. ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE BUT NOT ARE LIMITED TO: Oversee sanitation operations in the Los Angeles area (worksite may vary) Lead and develop sanitation teams, including Leads and Supervisors (20+ staffs) Manage and execute theMaster Sanitation Schedule (MSS) Ensure compliance with USDA, FDA, GMP, FSMA, and SQF standards Conduct ATP and allergen testing to verify sanitation effectiveness Oversee proper chemical handling, safety, andstorage Lead internal and external audits andensure audit readiness Perform regular facility inspections and implement improvements Partner with QA/QC and Maintenance teams to support food safety and operational efficiency QUALIFICATIONS: 7+ years of experience in food manufacturing environments 3-5 years of sanitation leadership experience(multi-site preferred) Strong knowledge of GMPs, SSOPs, and FSMA Preventive Controls Experience in SQF-certified facilities preferred. PCQI certification preferred Solid understanding of LOTO procedures, OSHA regulations, and plant safety programs Proven ability to lead and manage supervisors across multiple locations Experience leading regulatory and third-party audits Spanish bilingual required Strong organizational, analytical, and leadership skills Proficiency in reporting systems and documentation management Willingness to travel domestically and work a flexible schedule (including nights and weekends) Benefits: Medical/Dental/Vision/Life, 401k, Vacation, Holidays, Sick Leave and KPI Bonus. The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs. At Staffmark, we connect hardworking people with great companies, creating opportunities that make a lasting impact. Staffmark is an equal opportunity employer. Allapplicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Staffmark offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Staffmark is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.

Job Description\n Are you ready to bring your expert clinical skills to a world-class facility recognized as top ten in the country for cardiology? Do you have a passion for the highest quality and patient happiness? Then please respond to this dynamic opportunity available with one of the best places to work in Southern California! We would be happy to hear from you. Cedars-Sinai Medical Center has been recognized as #1 in California and eight years in a row on the “Best Hospitals” Honor Roll by U.S. News & World Report, 2023-24. \n The Cardiovascular Intervention Center is a core element of the Smidt Heart Institute, performing more than 8,000 procedures a year. The department serves the populations of neonates to and including geriatrics. In this twelve-laboratory facility, we perform a wide range of diagnostic and therapeutic procedures for coronary artery disease, heart muscle function and heart valve dysfunction. \n As a Catheterization Lab Technician, you will use physiological monitoring/recording systems to create, manipulate, improve, and record analog and digital radiographic images used in diagnostic, electrophysiology and interventional cardio-vascular procedures and examinations. You will perform a range of technical and supportive patient care tasks in accordance with facility and regulatory requirements. Experienced CVTs that meet the qualifications of Tech I and also have three years' experience along with ACLS and RCIS may qualify for the CVT Tech II position. \n \n We are currently offering a $5,000 sign-on bonus to newly hired Techs! \n Summary of Essential Duties: \n\n • Assists with CVIC procedures applying approved protocols per standards of practice for safety, speed, organization, precision, and accuracy based upon the department’s accrediting agency and/or department guidelines for exam protocols, adhering to department safety and productivity standards.\n, • Scrubs, monitors, assists, and circulates safely and timely, supplying necessary equipment and performing vascular site management, while supporting FDA approved and clinical research procedures.\n, • Performs all diagnostic tests, including coronary and structural heart intervention using electronic physiologic monitoring equipment and accurately records ECG, electrograms, hemodynamics, echocardiographic and other vital tracing obtained throughout the procedure.\n, • Prepares and administers contrast and follows department procedures and guidelines in handling of contrast to maintain compliance with all safety requirements. Observes radiation and laser protection to regulatory safety requirements.\n, • Performs sterile processing within guidelines for sterile field and equipment preparation, including inspection, counting, cleaning, patient and equipment transport, room stock, and documentation, with notification to supervisor and action needed for resolution.\n\n Sign-on bonus is available to newly hired Techs only. Current employees are not eligible. \n\nQualifications\n Education: \n\n • High School Diploma or GED required\n, • Successful completion of an Accredited CVT program with at least 800 hours of clinicals as part of that training program required\n\n License/Certifications: \n\n • Basic Life Support from the American Heart Association or American Red Cross required\n, • ACLS preferred. ACLS is required if put into a Tech II position\n, • RCIS preferred. RCIS is required if put into a Tech II position.\n\n Experience: \n\n • Previous Cath Lab experience preferred; graduates of a CV Tech program with no experience can be considered at the Tech I level\n, • At least 3 years of Cath Lab experience required to qualify for Tech II position\n, • Congenital Heart experience preferred\n\n #JOBS \n Keywords: Cardiac, Cardiovascular, Cath, Catheterization, Lab, Laboratory, Heart, Procedure, Tech, Technologist, Technician, Healthcare, Hospital, Medical Center, Los Angeles, CA, California

Job Description\n Are you ready to bring your expert clinical skills to a world-class facility recognized as top ten in the country for cardiology? Do you have a passion for the highest quality and patient happiness? Then please respond to this dynamic opportunity available with one of the best places to work in Southern California! We would be happy to hear from you. Cedars-Sinai Medical Center has been recognized as #1 in California and eight years in a row on the “Best Hospitals” Honor Roll by U.S. News & World Report, 2023-24. \n The Cardiovascular Intervention Center is a core element of the Smidt Heart Institute, performing more than 8,000 procedures a year. The department serves the populations of neonates to and including geriatrics. In this twelve-laboratory facility, we perform a wide range of diagnostic and therapeutic procedures for coronary artery disease, heart muscle function and heart valve dysfunction. \n As a Catheterization Lab Technician, you will use physiological monitoring/recording systems to create, manipulate, improve, and record analog and digital radiographic images used in diagnostic, electrophysiology and interventional cardio-vascular procedures and examinations. You will perform a range of technical and supportive patient care tasks in accordance with facility and regulatory requirements. \n We are currently offering a $5,000 sign-on bonus to newly hired Techs! \n Summary of Essential Duties: \n\n • Assists with CVIC procedures applying approved protocols per standards of practice for safety, speed, organization, precision, and accuracy based upon the department’s accrediting agency and/or department guidelines for exam protocols, adhering to department safety and productivity standards.\n, • Scrubs, monitors, assists, and circulates safely and timely, supplying necessary equipment and performing vascular site management, while supporting FDA approved and clinical research procedures.\n, • Performs all diagnostic tests, including coronary and structural heart intervention using electronic physiologic monitoring equipment and accurately records ECG, electrograms, hemodynamics, echocardiographic and other vital tracing obtained throughout the procedure.\n, • Prepares and administers contrast and follows department procedures and guidelines in handling of contrast to maintain compliance with all safety requirements. Observes radiation and laser protection to regulatory safety requirements.\n, • Performs sterile processing within guidelines for sterile field and equipment preparation, including inspection, counting, cleaning, patient and equipment transport, room stock, and documentation, with notification to supervisor and action needed for resolution.\n\n Sign-on bonus is only available to newly hired Techs. Current employees are not eligible. \n\nQualifications\n Education: \n\n • High School Diploma or GED required\n, • Successful completion of an Accredited CVT program with at least 800 hours of clinicals as part of that training program required\n\n License/Certifications: \n\n • Basic Life Support from the American Heart Association or American Red Cross required\n, • RCIS from Cardiovascular Credentialing International required\n, • ACLS and PALS preferred\n, • Applicants with no RCIS may be considered as a Cath Lab Tech I\n\n Experience: \n\n • At least 3 years of Cath Lab experience required to qualify for Tech II position\n, • Graduates of a CV Tech program with no experience can be considered at the Tech I level\n, • Congenital Heart experience preferred\n\n \n Keywords: Cardiac, Cardio, Cardiovascular, Cath, Catheterization, Lab, Laboratory, Medical Center, Hospital, Healthcare, Los Angeles, CA, California

We’re partnering with a rapidly growing global technology innovator that’s applying its expertise in precision automation, and vision systems to revolutionize neurosurgical robotics. The company’s FDA-cleared, navigated cranial robotic system is entering full commercialization across U.S. and international markets. The Global Product Manager will define and drive global product strategy for a next-generation neurosurgical robot used in deep brain stimulation, biopsy, and other minimally invasive cranial procedures. This role serves as the critical bridge between engineering, marketing, and clinical users — ensuring commercial success and product evolution across multiple regions. Please note: Relocation to San Diego is required within 12 months of hire. • Global Product Strategy: Develop and execute the global product roadmap, positioning, and launch strategy to drive adoption and market penetration., • Voice of Customer (VOC): Lead clinical and market research to capture insights from neurosurgeons, hospitals, and distributors; translate those into actionable product requirements., • Lifecycle Management: Oversee the product throughout its lifecycle, from concept through obsolescence — including enhancements, upgrades, and integration opportunities., • Market Development: Partner with regional sales and marketing teams to identify new indications, segments, and geographic expansion opportunities., • Competitive Intelligence: Monitor neurosurgical robotics, navigation, and image-guided surgery trends; deliver regular market insights to leadership., • Cross-Functional Collaboration: Work closely with R&D, regulatory, clinical, and operations teams to align development and commercialization priorities., • Commercial Enablement: Create sales tools, clinical value messaging, and training content to support global product launches., • KOL Engagement: Partner with leading neurosurgeons to advance validation studies, reference site development, and ongoing clinical feedback., • 7+ years of product management or marketing experience in the medical device industry, ideally within robotics, surgical navigation, neurosurgery, or capital equipment., • Proven success managing products through launch and global commercialization., • Background in engineering, biomedical sciences, or clinical applications preferred., • Strong understanding of hospital capital sales cycles, as well as regulatory and reimbursement dynamics., • Experience collaborating across international markets and cross-functional teams., • Exceptional communication, presentation, and stakeholder-management skills., • Bachelor’s degree required; MBA or advanced technical degree preferred.

Are You Ready?CAI is a 100% employee-owned professional services company established in 1996 that has grown year over year to nearly 850 people worldwide. For mission critical and FDA-regulated industries that need to deliver high-stakes solutions, we provide commissioning, qualification, validation, start-up, project management, and consulting services focused on operational readiness and performance excellence. Our approach is simple because our Purpose informs everything we do:We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.At CAI, we are committed to living our Foundational Principles, both professionally and personally:- We act with integrity- We serve each other- We serve society- We work for our future As owners, our shared success drives our team-first approach. We put clients’ interests first, never stop until it's right, and do whatever it takes to get there. CAI agents work with cutting-edge technologies in advanced medicine and regulated facilities. You will have opportunities to engage with leading experts, participate in hands-on certifications, and make a direct impact by helping bring life-saving therapies to market. Our collaborative, values-driven culture ensures delivery of excellence across all services. Job Summary:We are seeking an experienced and execution-focused Product Manager to serve as the owner of CAI’s expanding toolkit of digital products and services. In this role, you will drive innovation, alignment, and delivery of configurable, scalable, and compliant digital solutions that support operational readiness and operational excellence in regulated industries. You will own the full product lifecycle, act as Product Owner within Agile teams, and ensure successful delivery from intake through launch and continuous improvement. Key Responsibilities:1. Project & Delivery LeadershipOwn and drive end-to-end execution of digital product initiatives from intake through launch, ensuring delivery aligns with business and customer outcomes.Lead planning, scheduling, and coordination across cross-functional teams, managing dependencies, milestones, and deliverables.Develop and maintain delivery artifacts including delivery plans, RAID logs, milestone tracking, and action registers.Proactively identify risks, escalate issues as needed, and drive mitigation strategies to protect delivery commitments.Serve as the central owner for execution, ensuring work progresses efficiently and priorities remain aligned. 1. Product Strategy & Portfolio ManagementDefine and evolve the vision, strategy, and roadmap for CAI’s digital toolkit in alignment with business objectives and customer needs.Prioritize and manage a product backlog spanning multiple digital products and service components.Own the full product lifecycle from concept through deployment and continuous improvement, ensuring delivery of measurable business value., 2. Agile Product Ownership & ExecutionAct as Scrum Product Owner across one or more Agile teams, maintaining delivery momentum and achieving sprint goals.Translate business needs into clear epics, features, and user stories with defined acceptance criteria.Lead backlog refinement, sprint planning, reviews, and retrospectives in partnership with Scrum teams.Make real-time trade-off decisions to balance scope, risk, schedule, and value.Monitor sprint progress and velocity, adjusting plans as capacity or priorities change., 3. Stakeholder Management & Cross-Functional CollaborationFacilitate alignment and decision-making across operations, subject matter experts, regulatory advisors, technology partners, customer success, and leadership.Coordinate internal and external contributors to ensure deliverables are reviewed, approved, and implemented on schedule.Partner with marketing, sales, and delivery teams to support messaging, training, onboarding, and rollout activities.Communicate status updates, risks, and key decisions with clarity and consistency., 4. Customer-Centric Requirements & Compliance DeliveryGather, refine, validate, and manage requirements from internal and external stakeholders.Drive customer feedback loops and iterative MVP delivery while maintaining scope and delivery discipline.Ensure solutions align with global regulatory expectations including 21 CFR Part 11, GAMP 5, GxP, and ISO 27001, with appropriate validation rigor and documentation., 5. Solution Development, Scalability & Performance OptimizationLead development and configuration of reusable templates, workflows, and components to accelerate client time-to-value.Drive standardization and harmonization across digital products to support scalable, multi-site and global deployments.Track delivery, adoption, and performance metrics (cycle time, ROI, usage, quality outcomes) and use insights to continuously improve solutions and execution. Qualifications:Required:5+ years of experience in product management, digital transformation, or software delivery within life sciences or highly regulated environments.2+ years of experience as a Scrum Product Owner or equivalent Agile delivery role.Experience with digital validation, quality systems, or operational technology platforms (e.g., Kneat Gx, Veeva, TrackWise).Strong understanding of GxP, data integrity, and CSV principles.Excellent stakeholder management, communication, and prioritization skills. Preferred:Certified Scrum Product Owner (CSPO), Scrum Master, or equivalent certification.Experience with configurable SaaS platforms, productized services, or reusable digital toolkits.Familiarity with validation-related business processes including commissioning, qualification, change control, and quality risk management. #LI-MV1$140,000 - $160,000 a yearAverage base salary range - not including benefits and bonus. CAI Benefits:•Comprehensive Health Insurance coverage•24 days of Paid Time Off•ESOP/401K - 15% Company Contribution (US Only)•Company paid Life Insurance•Company paid Long Term DisabilityWe are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO). We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds... ClinChoice is searching for a Principal Clinical Data Scientist Consultant – R Programmer to join one of our clients. We are seeking a Clinical R programmer / Principal Clinical Data Scientist to join our Scientific Computing Technology group, which builds the open-source tools, R packages, SAS macros, and computing systems that power clinical programming, data management, and biostatistics across the organization. Reporting to the Director of Statistical Programming, this role blends hands-on clinical deliverables with contributions to the open-source and internal tooling that supports the wider clinical technical community. The ideal candidate has strong R skills, deep clinical programming experience, working Python familiarity, and an interest in modern, reproducible workflows. This position is open to remote candidates. • Develop, validate, and maintain SDTM and ADaM datasets in R — using admiral and the broader pharmaverse — following CDISC standards., • Generate Tables, Listings, and Figures (TLFs) in R or SAS as required by study needs., • Perform Pinnacle21 validation, resolve findings, and refine specifications to ensure CDISC compliance and submission readiness., • Write efficient, reproducible, well-structured R code for clinical data analysis and reporting., • Contribute to open-source and internal tooling — including R Shiny / teal modules, R packages, SAS macros, and Python utilities — used by clinical programming, data management, and biostatistics teams., • Partner with statisticians, data managers, and clinical teams to translate programming requirements into reliable deliverables., • Perform QC, reconcile data issues, and ensure outputs meet regulatory expectations (e.g., FDA, EMA)., • Support automation, pipeline development, and version-controlled workflows., • Use SAS for legacy studies or where SAS support is needed., • Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related field., • 5+ years in clinical programming, with a strong focus on R., • Proven experience producing SDTM and ADaM datasets in R, including hands-on use of admiral., • Experience with Pinnacle21 validation and remediation., • Working knowledge of SAS programming., • Working knowledge of Python for analytics, scripting, or tooling., • Solid understanding of CDISC standards (SDTM, ADaM) and metadata-driven programming., • Experience with clinical trial data, regulatory submissions, and QC processes., • Strong analytical, problem-solving, and documentation skills., • Broader pharmaverse experience (e.g., tidyCDISC, rtables) and tidyverse fluency., • Experience building or contributing to R Shiny apps, teal modules, or R packages used by other teams., • Exposure to AI/ML tooling in a clinical or programming context., • Real-World Evidence (RWE) experience — e.g., mapping Flatiron or claims/EHR data into CDISC-aligned structures., • R Markdown, Quarto, or other reproducible reporting workflows., • GxP validation, Git-based version control, and CI/CD or automated workflows., • CRO or pharmaceutical industry experience. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we have received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training are the core instruments to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our low industry-average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent, guided by a commitment to diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-#TT1 #LI-Remote #Principal#Contract

“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit _. Follow Mineralys on LinkedIn, Twitter and Bluesky” Mineralys is a fully remote company. Director Statistical Programmer The Director Statistical Programing (SP) reports to the SVP, Biometrics and is accountable for the production of SDTM and ADAM datasets and Tables, Listings, and Graph output (TFLs) for clinical studies. They will collaborate with partner functions in the Clinical Development Department (e.g. Clinical Operations, Clinical Research, Biostatisticians). They will be accountable for Medical Affairs support by providing output for posters, presentations, and publications. Key Responsibilities: • Accountable for all core SP deliverables (SDTM, ADAM, TFLs), • May also be accountable for clinical programming tasks (creation of SDTM and complex edit checks), • Provides ongoing data review by providing programmed edit checks, risk-based monitoring metrics, and draft TFLs, • With IT, defines our programming environment and its validation, • Responsible for the development of standards, SOPs, and best practices, • The role is a combination of vendor oversight, supervision of more junior statistical programmers, and some hands-on work., • The Director SP will supervise assigned junior programmers, both contractors and regular staff members. Qualifications • BS/BA degree and 10+ years of experience in analyzing clinical data OR, • MS in statistics or related area and 7+ years of experience in analyzing clinical data., • Experience with FDA submissions and the provision of data submission packages, • Experience in multiple areas outside of clinical development (e.g. pre-clinical, medical affairs, RWE), • Deep knowledge of the SAS programming language, • Demonstrated accomplishments in automatization (usually through SAS macro development), • Working knowledge of at least one other programming language, preferably R, • Experience with using genAI to create programming code or data processing algorithms., • Ability to work in an interdisciplinary team in a collaborative way, • Represents biometrics in a positive and professional manner, • Ability to work in a fast-paced team environment with fluctuating priorities, • Common sense and solution-oriented mindset, • Intellectual curiosity with a sense of pragmatic implementation of new ideas, • Ability to communicate effectively in English, both orally and in writing. Core Competencies • Strong understanding of clinical development processes and regulatory expectations, • Ability to lead and influence in a matrixed environment, • Demonstrated ability to balance urgency with quality, • Analytical rigor with a pragmatic, execution-oriented mindset Travel • This position requires up to 10% travel. Frequently travel is outside the local area and overnight. This position is eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level. US Salary Range: $235,000 - $248,000 #LI-Remote