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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. Job Title Territory Manager III, DBS - Sacramento, CA Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: • Career development with an international company where you can grow the career you dream of., • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year, • An excellent retirement savings plan with high employer contribution, • Tuition reimbursement, the student debt program and education benefit - an affordable and convenient path to getting a bachelor’s degree., • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune., • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. Neuromodulation Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. The Opportunity As a member of the regional sales team, the Territory Manager III will be responsible for leading the strategy within an assigned territory to accomplish planned objectives as to sales volume, market penetration, and profitability while ensuring alignment and collaboration across the team and with sales leadership. The incumbent will work in a highly matrixed, geographically diverse environment under general direction with clinical and sales teammates to identify and capitalize on sales opportunities by creating competency, comfort, and expertise with Abbott therapies among physicians, support staff and customers. The incumbent will perform work that involves a high degree of independence and will exercise sound judgment in planning, organizing, and performing work while continually seeking to improve territory efficiency. What You’ll Work On • Identifies strategies to increase referrals of Abbott therapies and overcome barriers that are restricting the national growth and adoption of the therapies, • Integrates into accounts, builds trust, and establishes strong rapport with with new and existing customers, key opinion leaders (KOLs), and industry leaders, • Generate additional sales revenue in assigned region by running initiatives targeted at increasing referrals of eligible patients, • Exercises considerable latitude in determining the technical objective of work assignments, • Trains and mentors new Territory Mangers, • Collects and studies information about new and existing products and monitors competitor sales, prices and products, • Ensures prompt follow-up of sales leads, investigation of complaints, and timely completion and filing of standard reports, • Fosters high trust relationships with colleagues including the regional teams and area leadership, • Conducts evaluations and develops sales strategies for capital equipment opportunities within accounts, • Coordinates implanting schedules of aligned Territory Managers and Clinical Specialists, • Interfaces and interacts with patients up to 50% of the time, • Demonstrates fiscal responsibility by effectively managing consigned inventory used in the territory, • Analyzes sales statistics, prepares reports, and performs required administrative sales duties such as filing expense account reports, scheduling appointments, and making travel plans, • Exercises authority to make sales commitments for assigned efforts and is accountable for results, • Attends trade shows where new products and technologies are showcased; meet other sales representatives and clients to discuss new product developments, • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments, • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors, • Performs other related duties and responsibilities, on occasion, as assigned Required Qualifications • Bachelor’s degree In a related field - an equivalent combination of education and work experience, • 8 or more years of sales experience in medical devices, • 4 or more years of work experience in Neuromodulation, • Ability and willingness to travel within assigned area on a regular basis (% of travel varies by area), • Capable and willing to work an unpredictable schedule that may change on short notice, • Excellent verbal, written and presentation skills with the ability to effectively communicate at multiple levels and to large groups within and outside the organization, • Capable of managing multiple projects and accustomed to tight deadlines Preferred Qualifications • Prefer bachelor’s degree in biomedical engineering or related field, • Prefer candidates with demonstrated leadership capabilities _ Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: _ Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at , on Facebook at , and on Twitter @AbbottNews. The base pay for this position is $43,900.00 – $109,200.00. In specific locations, the pay range may vary from the range posted.

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.

Job Description Join One of the Fastest-Growing Companies in Government Services! At ISN Corporation, headquartered in Bethesda, Maryland, we deliver specialized professional services to over 100 Federal government agencies across the country. Our reputation for excellence and results has earned us a spot on the Washington Business Journal’s list of the 50 Fastest Growing Government Contractors, as well as the Inc. 5000 list of Fastest Growing Private Companies—two years running! We’re not just growing fast—we’re building something great. Why You’ll Love Working at ISN: We believe great work starts with a great workplace. Here’s what we offer to support you: • Comprehensive medical coverage with prescription benefits, • Dental plan to keep you smiling, • Flexible spending accounts for smarter saving, • Company-paid short- and long-term disability insurance, • Free basic life insurance—because we’ve got your back, • A solid retirement plan to help you plan ahead, • Paid time off starting on Day 1 Who We’re Looking For: You’re organized, energetic, and ready to make an impact. You thrive in fast-paced environments, love checking things off your to-do list, and can juggle multiple priorities without breaking a sweat. Most importantly, you bring a positive attitude and a problem-solving mindset to everything you do. If you’re a self-starter with an eye for detail and a passion for excellence, we’d love to meet you. Mission. Innovation. Impact. Grow with us today! ISN is seeking Public Health (Tobacco Compliance) Inspectors or those who wish to become a Compliance Inspector to conduct undercover tobacco compliance inspections at retail locations throughout Alaska, Arizona, California, Colorado, Hawaii, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington and Wyoming. Inspectors will follow strict federal and state protocols to ensure compliance with the Family Smoking Prevention and Tobacco Control Act and Food & Drug Administration (FDA) guidelines. This position plays a critical role in enforcing tobacco regulations, preventing youth access to tobacco products, and ensuring compliance with advertising and labeling standards. A Public Health Tobacco Compliance Inspector needs to be reliable, detail-oriented, and ready to assist Underage Purchasers in performing non-confrontational compliance checks. Key Responsibilities: Compliance Inspections & Enforcement • Conduct Undercover Buy (UB) and Advertising & Labeling (A&L) inspections at licensed tobacco retail outlets., • Ensure compliance with FDA and State guidelines related to tobacco sales and marketing., • Properly document findings and maintain compliance with chain of custody protocols for evidence storage., • Coordinate with state and federal program officials to support compliance enforcement actions., • Provide testimony and declarations for enforcement or judicial actions when required., • Provide guidance and training to your paired Underage Purchaser to ensure that all inspection outcomes meet FDA standards and guidelines. Data Collection & Reporting • Accurately enter inspection results into the FDA Tobacco Inspection Management System (TIMS)., • Prepare and submit detailed reports on findings that align with the FDA program requirements., • Participate in routine quality assurance reviews to ensure inspection accuracy and procedural adherence., • Responsible for completing accurate reports for every inspection completed adhering to ISN's strict quality guidelines., • Ensure that all evidence handled is properly logged, secured, and shipped as required by the FDA. Training & Professional Development • All Compliance Inspectors will complete a series of paid training courses before being cleared to work with Underage Purchasers in the field., • Complete annual training and certification to maintain FDA Commissioned Inspector status., • Attend regular program meetings and refresher training sessions to stay updated on federal and state regulations., • Must be able to undergo a security clearance background check and become credentialed by the FDA. Experience/Skills: • All inspectors must be currently employed with a State or local government law enforcement agency or a regulatory agency to be contracted with the FDA program., • Must be able to provide proof of US Citizenship, • Strong attention to detail and the ability to follow strict compliance protocols., • Reliable Transportation, • Detail Oriented, • Strict adherence to deadlines and privacy Technical & Administrative Skills • Ability to document findings accurately and submit reports in a timely manner., • Strong communication and observational skills, • Familiarity with federal and state tobacco control laws is a plus. ISN Corporation is proud to be an Equal Opportunity Employer. We are an Equal Employment Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability status, marital status, genetic information, or any other characteristic protected by law. ISN Corporation maintains a Drug-Free Workplace. All candidates must successfully complete a pre-employment background investigation prior to starting employment.

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals LLC, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Validation Engineer At Nivagen as a Validation Engineer you will be responsible for ensuring that manufacturing processes, equipment, utilities, and systems in the sterile pharmaceutical production environment meet all regulatory requirements, industry standards, and company specifications. The role involves independently working and supporting the validation lifecycle from installation through qualification and routine re-validation activities, ensuring that the company's sterile manufacturing processes are in compliance with cGMP (current Good Manufacturing Practices) and other regulatory guidelines such as FDA, EMA, and ISO standards. Responsibilities: • Qualification of Equipment and Systems:, • Perform or oversee the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of new and existing equipment and systems., • Qualification of equipment in sterile manufacturing facility (e.g., aseptic processing, sterile filling, isolators, autoclave sterilization)., • Ensure compliance with regulatory requirements for equipment qualification and validation., • Knowledge of validation equipment like Kaye validator, temperature and RH data loggers etc., • Validation Documentation and Protocols:, • Prepare and review validation reports to ensure they meet regulatory and company requirements., • Maintain traceability of validation activities and ensure all validation records are accurately documented, maintained, and stored., • Process Validation and Cleaning Validation:, • Conduct and manage process validation studies to confirm the sterility and quality of pharmaceutical products., • Work with cross-functional teams (e.g., production, quality control, engineering) to optimize manufacturing processes and ensure consistency and repeatability., • Support the development and implementation of new processes, ensuring that they are validated per regulatory requirements., • Knowledge of cleaning validation will be an added advantage, • Perform any additional tasks as assigned by the Validations Lead Qualifications: Education/Experience: • Bachelor's degree or Diploma in Pharmaceuticals, or a related field., • Minimum 2 years of experience in a pharmaceutical manufacturing or validation role, with a focus on sterile manufacturing (e.g., aseptic processing, sterile filling, isolator, autoclave sterilization)., • Strong understanding of cGMP, FDA, EMA, ISO standards, and other relevant regulatory requirements., • Experience with equipment validation (e.g., filling machines, autoclaves, and HVAC systems) and process validation., • Familiarity with the documentation requirements for validation, including protocol development, execution, and report writing Knowledge, Skills, and Abilities: • Excellent technical writing and documentation skills., • Strong attention to detail and ability to manage complex technical documentation., • Ability to work cross-functionally and manage multiple priorities., • Familiarity with data analysis tools and software used for validation testing and reporting (e.g., Excel, Validation Master Plans, LIMS systems)., • Aseptic processing or sterile manufacturing practices. Requirements: • Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius), • Willing to travel as needed basis to other manufacturing sites for vendor support Work Environment: • Cleanroom and sterile production areas with controlled environments., • Potential exposure to hazardous materials and chemicals used in pharmaceutical manufacturing processes. Benefits: • $90,000 to $105,000, • Yearly bonus eligibility, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, • Medical, dental and vision coverage, • Paid time off plan, • 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Job DescriptionMore than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies. The Supervisor, Quality Control (QC) is responsible for overseeing daily operations within the QC laboratory to ensure compliance with regulatory standards, internal procedures, and quality expectations. This position plays a critical role in maintaining data integrity through audit trail reviews, leading investigations of out-of-specification (OOS) results and deviations, and ensuring the lab remains in a consistent state of inspection readiness. We are multiple positions across the following schedules: Day Shift:• 6:00am to 6:30pm or• 6:30am to 7:00pm Night Shift:• 6:00pm to 6:30am or• 6:30pm to 7:00am Work Week Schedule:• Sunday, Monday, Tuesday + every other Wednesday or• Thursday, Friday, Saturday + every other WednesdayPhysical Demands • Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment., • Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.Work Conditions, • Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.Essential Duties & Key Responsibilities, • Lab work and supervisor roles: Lead routine quality control testing on raw materials, process intermediates, and final cell therapy products. Supervise the QC team, supporting data verification, leading investigations, prioritizing tasks, and collaborating with other teams. Perform tests, ensure compliance, maintain the lab, prepare reagents, aliquot samples, assist with assay transfer/validation, train staff, and manage supplies., • Data Integrity and Audit Trail Review: Ensure GMP compliance by conducting audit trail reviews, identifying data integrity issues, and ensuring proper documentation. Lead and document QC testing results, and assist with preparing and reviewing batch records, SOPs, and related documentation to ensure adherence to cGMP regulations., • Investigations and CAPA: Oversee Quality System investigations into OOS results, atypical findings, and lab deviations. Ensure root cause analysis, documentation, and implementation of CAPAs, collaborating with cross-functional teams to resolve quality issues., • Lab Inspection Readiness: Monitor lab conditions to ensure compliance with cGMP and FDA/EMA regulations, maintaining documentation, equipment logs, and records for inspection readiness. Lead preparation activities for internal and external audits, including document reviews and mock audits., • Team Leadership and Oversight: Manage and support a team of QC analysts, overseeing scheduling, training, and performance evaluations. Provide technical guidance and mentorship to ensure high-quality, compliant practices., • Documentation and Reporting: Review and approve analytical data, protocols, and reports for accuracy and compliance. Maintain metrics for lab performance, deviations, investigations, and audit trail reviews., • Identify opportunities to improve lab operations, workflow efficiency, and compliance practices, and actively participate in revising and developing SOPs and policies., • Collaborate with cross-functional teams to ensure that external requests and activities align with site priorities., • Perform other duties as requested by supervisor/manager to support QualityStay current with industry regulations, standards, and best practices related to quality control., • Stay current with industry regulations, standards, and best practices related to quality control. Minimum Qualifications, • Bachelor’s degree in Chemistry, Biology, or a related scientific discipline (Master’s degree preferred)., • Minimum of 5 years of experience in a GMP-regulated QC laboratory, with at least 2 years in a supervisory or lead role., • Strong knowledge of cGMP, FDA, and ICH guidelines., • Proven experience conducting audit trail reviews and leading laboratory investigations., • Excellent organizational, analytical, and communication skills., • Ability to manage multiple priorities and work in a fast-paced environment.Night shift is eligible for a shift differential pay of +7%.The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

Job DescriptionMore than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. The Manager, Facilities is responsible for overseeing and maintaining the physical tenant infrastructure, coordinating and executing maintenance and calibration/certification activities, operating utility systems, managing service providers, maintaining GMP and safety compliance, and serving as the liaison with the building landlord. They will work closely with other departments to support the overall goals of the organization, including managing facilities programs, services and activities. This will be an onsite role at our clinical manufacturing facility (3400 Business Drive) with a schedule of Monday - Friday (7 a.m. / 8 a.m. to 4 p.m. / 5 p.m.).Key Responsibilities:Facility Operations & Maintenance: Oversee the day-to-day operations and maintenance of the facility, ensuring all systems are functioning properly (HVAC, electrical, plumbing, security, etc.). Develop, implement and manage preventive maintenance and calibration programs to ensure the facility is GMP compliant. Collaborate with Facilities and Production Planning to schedule and coordinate repairs and maintenance activities for building systems and equipment. Ensure accurate record-keeping for facility operations, and equipment maintenance, including Computerize Maintenance Management System (CMMS) and logbooks. Manage vendor relationships for services such as cleaning, pest control, maintenance and calibration services, ensuring delivery of quality services and compliance with service agreements. Review and approve vendor service documentation Respond to facility-related requests, BMS and FMS alarms, and emergent issues Complete quarterly trend reviews for alarm management and pest control programs. Health, Safety & Compliance: Ensure the facility complies with all relevant safety, environmental, and regulatory requirements (e.g., OSHA, GMP, FDA, local building codes). Participate in regular inspections to identify and mitigate risks related to safety, health, and environmental impacts. Budget Management: • Support development and management of the facility’s operational and maintenance budget, controlling costs related to maintenance, repairs and outside services. Project Management: Plan and coordinate facility-related projects such as improvements and space planning. Manage projects related to the installation of new equipment. Work with other departments, external contractors and vendors to ensure successful project execution. Qualifications:Education: • Associate’s or Bachelor’s degree in Facility Management, Engineering, or a related field preferred. Experience:, • 5 years of experience in facility management in a GMP environment, preferably in the cell therapy, biotechnology or pharmaceutical manufacturing facility.Skills: Strong knowledge of building systems (HVAC, electrical, plumbing), maintenance and calibration programs, GMP regulatory standards, and safety requirements in the biopharmaceutical/cell therapy industry. Excellent leadership, communication, and interpersonal skills. Experience/proficiency with maintenance management software and systems. Excellent project and time management skills with the ability to oversee multiple tasks at once. Strong problem-solving and troubleshooting, and ability to make sound decisions. Working Conditions: The position requires on-site presence and typically involves regular office hours but may require on-call availability and after-hours presence for planned or unplanned work, or emergency response. Gowning for cleanroom access. The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment. 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.

Job Description About the Company: Nivagen is a global company and serves an extraordinary purpose to make a difference in people's lives by discovering, developing, and delivering the most cost-effective generic prescription drugs and over-the-counter products for the North American market. For a decade, we have stayed true to a core set of values: excellence, integrity, and respect for people. We are also committed to investing in our employees and supporting a culture of well-being through competitive pay, comprehensive employee benefits programs, and training and development resources. Job Location: Nivagen Pharmaceuticals LLC, 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: As a Distribution Manager at Nivagen, you will be responsible for warehouse operations, including material handling, receipt, storage, issuance, and stockkeeping. Responsibilities: • Oversee daily warehouse and distribution operations to ensure efficiency, accuracy, and compliance Supervise, organize, and train warehouse personnel. • Develop and implement operational processes for storage, handling, and distribution., • Ensure alignment of warehouse operations with business objectives and regulatory requirements, • Interpret and implement DEA regulations under 21 CFR Parts 1300–1321, • Ensure compliance with all federal and applicable state controlled substance laws, • Maintain adherence to FDA regulations, including Current Good Manufacturing Practices (cGMP), • Prepare for, coordinate, and manage regulatory inspections and audits (DEA, FDA, and other agencies), • Maintain secure storage systems, including vaults, safes, and cages for Schedule I–II substances, • Control and restrict access to areas storing Schedule III–V substances, • Implement and monitor surveillance systems to prevent theft, diversion, or unauthorized access, • Enforce strict security protocols for handling controlled substances, • Conduct routine and random inventory audits, • Track lot numbers, batch numbers, and expiration dates, • Reconcile physical inventory with electronic systems, • Investigate and resolve discrepancies promptly, • Maintain accurate and compliant records, including:, • DEA Form 222 (ordering Schedule I & II substances), • DEA Form 41 (destruction of controlled substances), • Chain-of-custody documentation, • Ensure timely and accurate reporting of theft, loss, or diversion to the DEA, • Maintain audit-ready documentation at all times, • Train employees on controlled substance handling procedures and SOPs, • Educate staff on diversion prevention and regulatory compliance requirements, • Conduct ongoing training sessions and periodic refresher programs, • Promote a culture of compliance and accountability, • Maintain warehouse cleanliness in accordance with cGMP standards, • Implement procedures to prevent contamination and ensure product integrity, • Conduct regular inspections to ensure compliance with sanitation standards, • Ensure proper temperature and humidity conditions for all stored products, • Maintain monitoring systems, logs, and alarm notifications, • Respond promptly to temperature excursions and document corrective actions, • Ensure maximum operational efficiency while maintaining full regulatory compliance, • Develop systems for product handling, storage, shipping, and equipment utilization, • Manage inventory flow, logistics, and distribution processes, • Maintain high standards of productivity, quality, and customer service, • Ensure workplace safety and compliance with all applicable laws and regulations, • Develop and execute purchasing strategies aligned with operational needs, • Review and process purchase orders accurately, • Maintain detailed records of goods ordered and received, • Coordinate delivery schedules and ensure timely fulfillment, • Research and evaluate vendors for cost, quality, and service, • Collaborate with management to forecast inventory needs and maintain optimal stock levels, • Perform other duties as assigned by management Qualifications: Education/Experience: • Minimum 3 - 5 years of experience in any one of the following, or a combination of the following: Distribution, Warehousing, Shipping, Receiving, Logistics, Material handling, Customer Service, Inventory Control, or other comparable service line, • Must have a minimum of 2 years of experience in Pharmaceutical Manufacturing Experience, • Forklift experience (required) Knowledge, Skills, and Abilities: • Strong background in warehouse operations, preferably in a GMP manufacturing facility, • Good knowledge of regulatory guidance and standard operating procedures related to the warehouse, • Good documentation and communication skills Requirements: • Valid driver's license and acceptable driving record., • Legally authorized to be employed in the United States, • Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles' radius), • Able to successfully complete a drug and background check, • Able and willing to walk, stoop, stand, bend, and lift throughout each shift, with or without accommodation, • Completion of picking, packing, and closing competency assessments Benefits: • Full-Time Exempt, • Compensation: $80,000 - $90,000 (Based on Experience), • Yearly bonus eligibility, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, • Medical, dental, and vision coverage, • Paid time off plan, • 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Type: Full Time Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA About the Job: Title of the Position: Senior Scientist - Formulation Development We are seeking a highly skilled and experienced Senior Scientist to join our Formulation Development team. The successful candidate will play a critical role in the development and optimization of drug formulations from early-stage research through commercialization. This position requires a deep understanding of formulation principles, a strong scientific background, and a proven track record of success in the pharmaceutical industry. Responsibilities: • Lead the design, development, and optimization of complex injectable and sterile dosage forms., • Develop and implement robust formulation development strategies aligned with regulatory guidelines (e.g., Quality by Design, FDA)., • Apply scientific fundamentals and creative problem-solving skills to solve complex technical issues, • Conduct rigorous experimental design studies (e.g., factorial design) to achieve project objectives., • Collaborate closely with cross-functional teams, including Technical Services, Operations, and Regulatory Affairs., • Define scope, timeline, and resource needs of functional activities and keep team on schedule, • Participate in evaluation of new product opportunities., • Ensure timely and high-quality documentation for regulatory submissions., • Stay updated with all FDA and regulatory requirements/guidelines., • Provide mentorship and leadership to team members., • Stay up to date with the latest scientific advancements in formulation development and applying new technologies to improve product performance., • Author and review technical reports, protocols, and regulatory documents., • Additional duties and assignments as needed. Qualifications: Education/Experience: • Ph.D. or Postgraduate degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field., • 3+ years of hands-on experience in sterile/Injectable pharmaceutical formulation development. (Strong candidates with combinations of education and experience will be considered.), • Strong understanding of formulation principles, excipients, and drug delivery systems., • Hands-on experience with various formulation techniques and equipment., • Proven track record of successful formulation development and commercialization., • Experience with statistical design of experiments (DOE) and data analysis. Knowledge, Skills, and Abilities: • Proven track record of successful formulation development for various sterile dosage forms., • Strong leadership, project management, and organizational skills., • Expertise in complex injectable and sterile dosage form development., • Demonstrated ability to conduct independent research and problem-solving. Requirements: • Must live in or be willing to move to the Sacramento Metropolitan Region (approximately 40 miles in radius). Benefits: • Pay range $70,000-$90,000 per Year, • Yearly bonus eligibility, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, • Medical, dental and vision coverage, • Paid time off plan, • 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Job DescriptionMore than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies. The Specialist, Quality Assurance position is a key role in meeting the quality policy through their management of the different quality systems, including production records and deviation system management. The ideal candidate will be responsible for managing the quality systems, including deviations, change control, corrective and preventive actions (CAPA), and document management. Additionally, this role involves making timely batch disposition decisions to ensure quality standards are met before product release, supporting the rapid processing times required by our product. You will have the unique opportunity to make a difference in the lives of many patients as Orca Bio develops next-generation cell therapies.Physical Demands • Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment., • Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.Work Conditions, • Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.ResponsibilitiesQuality System Management:, • Oversee the management of quality systems including deviations, change controls, CAPAs, and document control., • Ensure that all deviations are investigated thoroughly and timely, identifying root causes and implementing effective corrective actions., • Review and approve change controls to ensure compliance with regulatory requirements and internal procedures., • Maintain and improve CAPA processes to ensure effective resolution of quality issues.Batch Disposition:, • Evaluate batch records and associated documentation to make informed batch release decisions., • Collaborate with manufacturing and quality control teams to ensure all products meet regulatory and quality standards before release., • Monitor and document any quality issues related to batch production and implement corrective measures as necessary.Document Management:, • Maintain the document management system to ensure all quality-related documents are accurate, current, and compliant with regulatory standards., • Conduct regular reviews of quality documentation to ensure adherence to established protocols and procedures.Regulatory Compliance:, • Stay informed of current regulations, industry trends, and best practices in pharmaceutical quality assurance., • Assist in preparing for internal and external audits, ensuring that all quality systems and documentation are audit-ready.Training and Support:, • Provide training and guidance to staff on quality systems, processes, and compliance requirements., • Serve as a point of contact for quality-related inquiries and issues, fostering a culture of quality within the organization.Continuous Improvement:, • Participate in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes., • Identify areas for improvement within quality operations and suggest appropriate solutions., • Track completion of quality records and maintain metrics., • Perform other duties as requested by supervisor/manager to support Quality, • Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.General Requirements, • Communicate effectively with team members and contribute to a positive and collaborative work environment, • Actively participate in group and project teamwork; project and process improvements, • Strong organizational skills and the ability to manage multiple tasks concurrently, • Willingness to learn and adapt in a fast-paced, dynamic environment, • Adhere to cGMP policies and procedures, including documentation activities, • Able to wear appropriate personal protective equipment, • Willingness to work overtime as requiredExperienced Required, • Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 3+ years of experience in quality control testing, analytical development, or GMP; OR a Master’s degree in relevant scientific disciplines with 1+ years of experience, • Understanding of FDA regulations, GMP compliance, and quality system processes, • Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred, • Able to meet project and testing timelines, • Detail-oriented with a commitment to data integrity and accuracy, and an ability to identify problems with data management, • Able to work collaboratively to respond to changing priorities and challenges, • Ability to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment, • Prior experience doing internal audits and document control managementThe anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment. 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.

Job DescriptionMore than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. The Materials and Cold Chain Operations Supervisor is responsible for overseeing daily operations associated with material supply, material handling, cryogenic storage, and cold chain packaging and shipping of cell therapy drug products. This role ensures that GMP-compliant handling, storage, packaging, and distribution of materials and drug products are performed safely, accurately, and in accordance with regulatory requirements, internal procedures, and chain-of-identity/chain-of-custody controls. The supervisor leads a team of material handlers and cryogenic processing/packaging specialists, ensuring operational readiness, inventory control, and timely shipment of critical materials and patient-specific drug products. Day Shift Hours worked: • 7:00 AM – 3:30 PM• Coverage: Core business hours + early escalations Work Week Schedule: • Monday - Friday Please note there will be on call rotation between Day Shift and Night Shift supervisors. This is to ensure coverage for the off hours (3:30pm - 10pm and weekends). Essential Duties & Key Responsibilities: Materials Supply: Ensure materials and drug product shipments align with manufacturing schedules and patient treatment timelines. Coordinate activities for supplying GMP material for manufacturing, laboratory and facility operations Support receipt, inspection, storage, and distribution of GMP materials. Ensure proper inventory control within ERP/MES/WMS systems. Ensure accurate chain-of-identity (COI) and chain-of-custody (COC) controls for patient-specific materials and drug products. Cold Chain Management: Oversee cryogenic and cold chain storage systems, including LN2 freezers and associated monitoring systems. Supervise drug product cryopreservation handling and storage workflows. Ensure compliant pack-out and shipment of cold chain drug products using validated shippers. Coordinate shipments with couriers and logistics partners. Ensure accurate chain-of-identity (COI) and chain-of-custody (COC) controls for patient-specific materials and drug products. Supervision: Ensure operations comply with: GMP (Good Manufacturing Practices), GDP (Good Distribution Practices), GTP (Good Tissue Practices) where applicable and Internal SOPs and regulatory requirements Support quality investigations, deviations, CAPAs, and change controls. Ensure proper documentation, batch record completion, and data integrity. Support internal and external regulatory inspections and audits. Supervise and develop a direct reports Promote a safety-first and quality-first culture. Identify and implement process improvements in material flow, inventory control, and shipping operations. Minimum Experience, Education, Certifications, Licenses: • Bachelor’s degree in operations management, or supply chain plus 2 years of supervisory experience or 5 years of experience in cell therapy, biologics, pharmaceutical manufacturing or warehouse / supply chain with 2 years of supervisory experience Experience in material management and supply Experience in cold chain operations including cryopreservation and cold chain shipments Experience with Inventory management systems Preferred experience with FDA and Good Manufacturing Practice (GMP) knowledge Preferred experience with chain of identity and chain of custody controls. Strong understanding of good documentation practices and data integrity requirements. Key Competencies: Operational leadership Attention to detail and quality mindset Strong organizational and planning skills Ability to manage time-critical patient product shipments Cross-functional communication Problem solving and continuous improvement Reporting Structure & Authority: Direct reports include: Material Handlers and Handling and Cryopreservation Associates Define Supervisory responsibilities: Recruits, interviews, hires, and trains new staff Oversees the daily workflow of the department Provides constructive and timely performance feedback and evaluations Resolves issues and escalates issues for support as needed Physical Demands: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment. Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed. Work environment includes: Ability to lift 25 lbs Handling of cryogenic materials (liquid nitrogen systems) May require shift, weekend, or holiday coverage to support manufacturing and patient treatment timelines. Travel Requirements:This position works onsite and does not require travel. The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment. 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.

Job DescriptionMore than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies. The Specialist, Training works to develop, deliver and optimize classroom and hands on training programs that support the development and enhancement of skills related to GMP operations in a commercial manufacturing environment. The role ensures that personnel are trained effectively on standard operating procedures (SOPs), equipment use, safety protocols, and regulatory compliance to achieve production goals and maintain quality standards. Night Shift Hours Worked:• 6:00pm to 6:30am or• 6:30pm to 7:00am Work Week Schedule:• Sunday, Monday, Tuesday + every other Wednesday or• Thursday, Friday, Saturday + every other WednesdayPhysical Demands • Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment., • Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.Work Conditions, • Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.Key Responsibilities:, • Develop comprehensive training programs and materials for roles across the GMP commercial operations of cell therapies including, but not limited to, manufacturing, quality control, and warehousing., • Create training modules, presentations, and manuals that align with regulatory requirements, GMP guidelines, and company policies., • Conduct classroom training sessions, workshops, on the job training, and hands-on demonstrations, on a daily basis, to impart technical knowledge and skills to staff., • Assess trainee competencies and learning outcomes through practical evaluations and knowledge assessments., • Provide constructive feedback and coaching to trainees to support their skill development and performance improvement., • Maintain accurate training records and documentation to demonstrate compliance with training requirements., • Optimizes training programs to support scalability and reduced time to operator proficiency., • May require shift, weekend, or holiday coverage to support manufacturing and patient treatment timelines., • Supports training system compliance and other duties as assignedMinimum Qualifications, • Bachelor's degree in a relevant field such as Biotechnology, Engineering, or Education; advanced degree preferred, • Minimum of 2 years of relevant experience in training and development, preferably in a manufacturing or biotechnology environment, • Strong understanding of cGMP regulations, FDA guidelines, and other relevant quality standards applicable to pharmaceutical or biotech manufacturing, • Excellent communication, presentation, and interpersonal skills, with the ability to engage and motivate diverse audiences, • Proven ability to manage multiple projects concurrently, prioritize tasks effectively, and adapt to changing priorities in a fast-paced environment, • Proficiency in MS Office applications and learning management systems (LMS) is requiredPreferred Qualifications, • Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred, • 2+ years of experience in quality control testing, analytical development, or GMP quality operationsThe anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment. 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.

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: In Process QA Specialist (Full Time) At Nivagen as an In Process QA Specialist you will be responsible for ensuring that pharmaceutical products meet quality standards during the manufacturing process. This role involves real-time monitoring, sampling, testing, and documentation to identify and address any quality issues as they arise, ensuring that all production activities comply with Good Manufacturing Practices (GMP) and regulatory requirements. Responsibilities: In this role, you will: · Perform routine on-the-floor QA oversight within manufacturing areas, providing real-time quality support and ensuring compliance with approved procedures and GMP requirements. · Conduct line clearances, in-process checks, and verification activities during manufacturing and packaging operations. · Review and approve GMP documentation including batch production records, logbooks, sampling records, and associated manufacturing documentation. · Support deviation investigations by gathering information, participating in root cause analysis, and assisting with CAPA development and effectiveness checks. · Support the authoring, review, and approval of QA Manufacturing procedures, controlled documents, and Master Batch Records to ensure compliance with cGMP, regulatory requirements, and internal quality standards. · Participate in GMP area walkthroughs and support inspection readiness activities. · Support internal audits, regulatory inspections, and customer audits by preparing documentation and providing operational support. · Collaborate cross-functionally with Manufacturing, Engineering, Validation, and Supply Chain teams to resolve quality issues and drive continuous improvement. · Assist with product disposition activities and quality review processes under supervision. · Promote a culture of quality, compliance, and operational excellence within the organization. Qualifications: Education/Experience: · Bachelor's degree in Life Sciences, Chemistry, Engineering, or related field OR equivalent combination of education and sterile GMP manufacturing experience. · 0–3 years of experience in sterile pharmaceutical, biotech, or other regulated manufacturing environments. · Working knowledge of current Good Manufacturing Practices (cGMP) and applicable FDA regulations (21 CFR). · Strong organizational skills and attention to detail. · Effective written and verbal communication skills. · Ability to work independently while collaborating within cross-functional teams. · Basic knowledge of deviation management, CAPA, and change control processes preferred. · Familiarity with electronic systems such as ComplianceWire, TrackWise, SAP, LIMS, or similar eQMS platforms preferred. · Proficiency in Microsoft Office applications. Knowledge, Skills, and Abilities: • Strong analytical and problem-solving skills with experience in root cause analysis and CAPA implementation, • High level of attention to detail, particularly in identifying quality deviations and documenting production processes, • Proficiency in using quality testing equipment and familiarity with statistical process control (SPC) methods, • Strong understanding of GMP, FDA regulations, and other relevant pharmaceutical industry standards, • Excellent communication skills, both verbal and written, for effective collaboration and documentation, • Ability to work effectively as part of a cross-functional team, including production, quality control, and regulatory affairs Job Requirements: Physical / Mental Requirements · Ability to apply sound judgment and make decisions aligned with company procedures and regulatory standards. · Strong analytical and problem-solving skills. · Ability to gown and work within controlled cleanroom environments. · Must be able to wear appropriate PPE (safety shoes, glasses, gloves, etc.). · Ability to stand for extended periods during manufacturing oversight activities. Work Environment / Schedule · Primarily day shift, Monday–Friday. · May require flexibility to support manufacturing operations, including occasional off-shift or weekend coverage. · Work Location Assignment: On-site / Manufacturing Facility ·This role requires spending significant time on the production floor, monitoring processes, and conducting tests in a cleanroom or controlled environment ·Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles' radius) Benefits: • Pay range $70,000 - $80,000 per Year, • Yearly bonus eligibility, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, • Medical, dental and vision coverage, • Paid time off plan, • 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors. We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Lab Technician - Document Writer Responsibilities: • Prepare, revise, and maintain analytical documents, including:, • Test methods and method validation protocols/reports, • Specifications, STPs, SOPs, control sheet, control work sheet and analytical procedures, • Change controls, deviations, CAPAs, and investigations, • Ensure documents comply with cGMP, FDA, ICH, and internal quality standards., • Manage document lifecycle activities using electronic quality systems., • Create and route documentation through approval workflows in TrackWise and eInfoTree., • Enter, review, and maintain analytical data and workflows in StarLIMS., • Collaborate with QC, QA, R&D, and Regulatory teams during document preparation and review., • Support internal and external audits by providing accurate and compliant documentation., • Maintain version control, archival, and traceability of analytical records., • Perform any additional tasks as assigned by management. Qualifications: Education/Experience: • High school/GED Degree. Knowledge, Skills, and Abilities: • Experience in assisting in preparing reports and writing documents., • Proficiency in Microsoft Office. Requirements: • Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles' radius) Benefits: • Pay range $25 to $27 an hour, • Yearly bonus and stock options eligibility, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, • Medical, dental, and vision coverage, • Paid time off plan, • 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Compounding Pharmacist (Full Time) The Compounding Pharmacist at Nivagen will be responsible for leading the 503B outsourcing facility, ensuring adherence to compounding standards and regulatory compliance. This role is pivotal in meeting manufacturing and company goals by overseeing the successful operations of a fully compliant department. Key responsibilities include maintaining facility and equipment standards, ensuring safety, upholding product quality, optimizing manufacturing efficiency, and managing quality systems in line with regulatory requirements. The Compounding Pharmacist will report directly to the CEO and/or the Production Manager. Responsibilities: • Work with Production Lead to achieve daily compounding output goals, • Design weekly production schedule with Production Lead, • Assign technician roles for the week (i.e. Mixer, Filler, Assistant, etc.), • Direct techs to a particular task to maintain production flow, • Complete Batch records, • Supervise compounding activities, • Perform Mixer, Filler, Assistant, or any technician duties as needed, • Check customer orders for accuracy, • Clinical customer service (Drug info, IV compatibility, osmolarity calculations etc.), • Controlled substance records management, • QA reports/investigations as assigned: MOCA, CAPA, MRDD, Complaints, • Maintain team's cGMP compliance at MSRX, • Participate in regulatory audits, • Draft SOPS revisions, process validation, draft a master compounding record, Process Validation etc, • Other duties as assigned by management or CEO and production manager Qualifications: Education/Experience: • Doctor of Pharmacy (Pharm.D.) degree from an accredited institution, • A minimum of two to three years of experience in a compounding pharmacy or a 503B outsourcing facility, or equivalent experience in related fields, is required Knowledge, Skills, and Abilities: • Understanding and experience in USP 797 guidelines and manual aseptic manipulations, • Strong leadership skills with the ability to manage and mentor a team, • Excellent communication and organizational skills, • Experience with regulatory audits and inspections is a plus., • Capable of maintaining confidentiality and handling sensitive information discreetly Requirements: • California Pharmacist License in good standing, • Knowledge and experience in cGMP and FDA 21 CFR parts 210 and 211, • Experience participating in a Manufacturing Unit in an FDA registered facility that includes cGMP compliance and sterile product preparation of pharmaceuticals OR experience as a pharmacist in a pharmacy that prepares sterile parenteral compounds, • Work in controlled environments and wear personal protective equipment as necessary, • Board certified Sterile Compounding pharmacist certification preferred., • Knowledge within the areas of quality control and process validation, • Familiarity and understanding of manufacturing methods related to quality control and quality assurance, • Experience participating in a supply chain management in an FDA approved GMP facility that includes cGMP compliance and sterile product preparation for pharmaceuticals, • Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius) Benefits: • Pay range $180,000 - $180,000 per year, • Bonus Target eligibility determined by the President, • Performance-Based Incentive, • Benefits: Medical, Dental, and Vision coverage, • Paid time off plan, • 401 (k) savings plan Conditions of Employment: • This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, a gown, and other items as required, • This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR), • Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve-hour shift. Must be able to lift up to 50lbs, • Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors. We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.

Job DescriptionMore than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. The Supervisor, Materials and Cold Chain Operations - Night Shift is responsible for overseeing daily operations associated with material supply, material handling, cryogenic storage, and cold chain packaging and shipping of cell therapy drug products. This role ensures that GMP-compliant handling, storage, packaging, and distribution of materials and drug products are performed safely, accurately, and in accordance with regulatory requirements, internal procedures, and chain-of-identity/chain-of-custody controls. The supervisor leads a team of material handlers and cryogenic processing/packaging specialists, ensuring operational readiness, inventory control, and timely shipment of critical materials and patient-specific drug products. Night Shift Hours worked: • 10:00 PM – 6:30 AM• Coverage: Overnight operations, early morning handoff Work Week Schedule: • Monday - Friday Please note there will be on call rotation between Day Shift and Night Shift supervisors. This is to ensure coverage for the off hours (3:30pm - 10pm and weekends). Essential Duties & Key Responsibilities: Materials Supply: Ensure materials and drug product shipments align with manufacturing schedules and patient treatment timelines. Coordinate activities for supplying GMP material for manufacturing, laboratory and facility operations Support receipt, inspection, storage, and distribution of GMP materials. Ensure proper inventory control within ERP/MES/WMS systems. Ensure accurate chain-of-identity (COI) and chain-of-custody (COC) controls for patient-specific materials and drug products. Cold Chain Management: Oversee cryogenic and cold chain storage systems, including LN2 freezers and associated monitoring systems. Supervise drug product cryopreservation handling and storage workflows. Ensure compliant pack-out and shipment of cold chain drug products using validated shippers. Coordinate shipments with couriers and logistics partners. Ensure accurate chain-of-identity (COI) and chain-of-custody (COC) controls for patient-specific materials and drug products. Supervision: Ensure operations comply with: GMP (Good Manufacturing Practices), GDP (Good Distribution Practices), GTP (Good Tissue Practices) where applicable and Internal SOPs and regulatory requirements Support quality investigations, deviations, CAPAs, and change controls. Ensure proper documentation, batch record completion, and data integrity. Support internal and external regulatory inspections and audits. Supervise and develop a direct reports Promote a safety-first and quality-first culture. Identify and implement process improvements in material flow, inventory control, and shipping operations. Minimum Experience, Education, Certifications, Licenses: • Bachelor’s degree in operations management, or supply chain plus 2 years of supervisory experience or 5 years of experience in cell therapy, biologics, pharmaceutical manufacturing or warehouse / supply chain with 2 years of supervisory experience Experience in material management and supply Experience in cold chain operations including cryopreservation and cold chain shipments Experience with Inventory management systems Preferred experience with FDA and Good Manufacturing Practice (GMP) knowledge Preferred experience with chain of identity and chain of custody controls. Strong understanding of good documentation practices and data integrity requirements. Key Competencies: Operational leadership Attention to detail and quality mindset Strong organizational and planning skills Ability to manage time-critical patient product shipments Cross-functional communication Problem solving and continuous improvement Reporting Structure & Authority: Direct reports include: Material Handlers and Handling and Cryopreservation Associates Define Supervisory responsibilities: Recruits, interviews, hires, and trains new staff Oversees the daily workflow of the department Provides constructive and timely performance feedback and evaluations Resolves issues and escalates issues for support as needed Physical Demands: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment. Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed. Work environment includes: Ability to lift 25 lbs Handling of cryogenic materials (liquid nitrogen systems) May require shift, weekend, or holiday coverage to support manufacturing and patient treatment timelines. Travel Requirements:This position works onsite and does not require travel. The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment. 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.

Job Description About the Company: Nivagen is a global company devoted to improving lives by developing high-quality, affordable generic prescription drugs and over-the-counter products for the North American market. For over a decade, we have remained committed to our core values of excellence, integrity, and respect for people. Our dedicated team works collaboratively to advance manufacturing, distribution, and quality control, taking a comprehensive approach to healthcare. Through vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and an unwavering focus on excellence, we continually strive to enhance medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and strong training and development programs. By investing in our workforce and nurturing a culture of growth and support, we empower our team to drive innovation and make a positive impact in healthcare. Our mission at Nivagen is clear: to improve lives by providing high-quality, affordable medications while upholding the highest standards of integrity and excellence. As a leader in pharmaceutical manufacturing, Nivagen is committed to producing sterile products that meet the healthcare industry's rigorous demands. Specializing in the production of vials, pre-filled syringes (PFS), and IV bags, we aim to make a meaningful impact on patient care. Join our team to help push the boundaries of sterile manufacturing, achieving the highest standards in safety, quality, and operational efficiency. Job Location: Nivagen Pharmaceuticals, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Director of Quality Control Department: Quality Control Reports to: Head of Quality The Director of Quality Control leads all QC operations within a pharmaceutical manufacturing facility, ensuring reliable, compliant testing that meets regulatory expectations and supports timely product release. This role oversees QC laboratories (chemistry, microbiology, analytical development support, raw materials, stability, and in-process testing), manages scientific and operational strategy, drives continuous improvement, and ensures data integrity and regulatory compliance across all laboratory activities. Responsibilities: Leadership & Management • Provide strategic leadership for QC teams, including chemistry, microbiology, stability, and raw materials testing., • Develop and mentor QC managers, supervisors, and analysts to ensure strong technical capability and compliance culture., • Establish resource plans, staffing, skills development, and succession planning., • Set performance expectations, conduct performance reviews, and manage career development. Laboratory Operations & Oversight • Direct day-to-day QC operations to support manufacturing schedules, ensuring on-time testing and release., • Oversee testing for raw materials, in-process samples, finished products, environmental monitoring, and stability programs., • Ensure proper functioning, maintenance, and qualification/calibration of all lab equipment., • Oversee sample management, laboratory workflows, and prioritization., • Implement robust OOS/OOT/OOE processes and drive investigations to scientifically sound conclusions. Regulatory Compliance & Quality Systems • Ensure all QC activities comply with cGMP, FDA/EMA/ICH guidelines, USP/EP/JV standards, and company SOPs., • Own and maintain quality systems related to laboratory operations, including:, • Change control, • Deviations and investigations, • CAPA management, • Document control, • Data integrity program, • Prepare for and lead QC aspects of regulatory inspections and internal/external audits., • Ensure laboratory data integrity practices meet ALCOA+ principles. Analytical Strategy & Method Management • Oversee method validation, verification, transfer, and lifecycle management activities., • Evaluate and implement new analytical technologies to improve QC reliability, efficiency, and scientific rigor., • Collaborate with R&D/Analytical Development to ensure smooth tech transfer of analytical methods and specifications., • Ensure the QC team supports process changes, comparability studies, and product lifecycle management. Stability Program Management • Oversee design, execution, and monitoring of stability studies in compliance with ICH guidelines., • Ensure timely stability testing and trend analysis to support expiry dating, regulatory filings, and ongoing product quality review. Quality Metrics & Continuous Improvement • Develop, track, and report quality metrics (e.g., OOS rate, lab investigation cycle time, test turnaround time, EM trends)., • Drive continuous improvement initiatives such as Lean lab practices, automation, and digitalization., • Optimize laboratory workflows for efficiency while maintaining compliance and data integrity. Cross-Functional Collaboration • Act as a QC subject matter expert in cross-functional teams, including QA, Manufacturing, Regulatory Affairs, Supply Chain, and R&D., • Participate in material/vendor qualification, change control reviews, and deviation boards., • Support regulatory submissions by providing QC data, summary reports, and responses to agency questions. Qualifications: Education/Experience: • Master's or PhD in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or related discipline preferred., • A bachelor's degree with extensive experience may be considered., • 10+ years of experience in QC within pharmaceutical or biopharmaceutical manufacturing., • 5+ years of leadership/management experience in a GMP laboratory setting., • Experience preparing for and hosting inspections by FDA, EMA, or other health authorities., • Strong background in analytical chemistry and/or microbiology., • Experience with method validation, QC automation, LIMS/ELN, and electronic data management systems. Knowledge, Skills, and Abilities: • Deep knowledge of cGMP, ICH guidelines, USP/EP, and regulatory expectations., • Strong scientific judgment and technical problem-solving skills., • Excellent leadership, communication, and interpersonal skills., • Ability to manage multiple priorities and drive timely execution., • Demonstrated ability to develop high-performing teams and a culture of quality and compliance. Requirements: • Must live or be willing to move to the Sacramento Metropolitan Region (Approx 40 miles' radius) Benefits: • Pay range: Competitive Salary Range $120k - $150k Annually, • Yearly bonus eligibility, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being (Medical, dental, and vision coverage), • Paid time off plan, • 401 (k) savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Job DescriptionMore than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials. The Specialist, Quality Assurance position is a key role in meeting the quality policy through their management of the different quality systems, including production records and deviation system management. The ideal candidate will be responsible for managing the quality systems, including deviations, change control, corrective and preventive actions (CAPA), and document management. Additionally, this role involves making timely batch disposition decisions to ensure quality standards are met before product release, supporting the rapid processing times required by our product. You will have the unique opportunity to make a difference in the lives of many patients as Orca Bio develops next-generation cell therapies.Physical Demands • Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment., • Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.Work Conditions, • Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs., • Must be comfortable regularly participating in video-based meetings., • May be required to work scheduled overtime, weekends, or holidays based on business needs.ResponsibilitiesQuality System Management:, • Oversee the management of quality systems including deviations, change controls, CAPAs, and document control., • Ensure that all deviations are investigated thoroughly and timely, identifying root causes and implementing effective corrective actions., • Review and approve change controls to ensure compliance with regulatory requirements and internal procedures., • Maintain and improve CAPA processes to ensure effective resolution of quality issues.Batch Disposition:, • Evaluate batch records and associated documentation to make informed batch release decisions., • Collaborate with manufacturing and quality control teams to ensure all products meet regulatory and quality standards before release., • Monitor and document any quality issues related to batch production and implement corrective measures as necessary.Document Management:, • Maintain the document management system to ensure all quality-related documents are accurate, current, and compliant with regulatory standards., • Conduct regular reviews of quality documentation to ensure adherence to established protocols and procedures.Regulatory Compliance:, • Stay informed of current regulations, industry trends, and best practices in pharmaceutical quality assurance., • Assist in preparing for internal and external audits, ensuring that all quality systems and documentation are audit-ready.Training and Support:, • Provide training and guidance to staff on quality systems, processes, and compliance requirements., • Serve as a point of contact for quality-related inquiries and issues, fostering a culture of quality within the organization.Continuous Improvement:, • Participate in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes., • Identify areas for improvement within quality operations and suggest appropriate solutions., • Track completion of quality records and maintain metrics., • Perform other duties as requested by supervisor/manager to support Quality, • Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.General Requirements, • Communicate effectively with team members and contribute to a positive and collaborative work environment, • Actively participate in group and project teamwork; project and process improvements, • Strong organizational skills and the ability to manage multiple tasks concurrently, • Willingness to learn and adapt in a fast-paced, dynamic environment, • Adhere to cGMP policies and procedures, including documentation activities, • Able to wear appropriate personal protective equipment, • Willingness to work overtime as required, • Be available to provide on-call support outside regular business hours as needed Experienced Required, • Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 3+ years of experience in quality control testing, analytical development, or GMP; OR a Master’s degree in relevant scientific disciplines with 1+ years of experience, • Understanding of FDA regulations, GMP compliance, and quality system processes, • Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred, • Able to meet project and testing timelines, • Detail-oriented with a commitment to data integrity and accuracy, and an ability to identify problems with data management, • Able to work collaboratively to respond to changing priorities and challenges, • Ability to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment, • Prior experience doing internal audits and document control managementThe anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment. 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.

Job Description WORK LOCATION • 2970 Ramco Street, West Sacramento, CA 95691 No remote work available JOB SUMMARY We are seeking an entry-level Quality Assurance Technician to join our team and learn food safety and quality systems. This role offers hands-on training in regulatory compliance, documentation, and quality assurance practices within the food industry. You'll work closely with experienced team members while supporting our quality programs and customer service efforts. ESSENTIAL DUTIES AND RESPONSIBILITIES Documentation & Customer Support • Prepare certificates of analysis (COAs), specification sheets, and product documentation under supervision, • Respond to customer inquiries regarding product specifications and quality matters, • Maintain organized records of ingredient and packaging specifications, • Assist with preparing responses to customer complaints and requests, • Quality & Compliance Support, • Learn and support company compliance with food safety regulations (CGMP, SQF, HACCP, FDA), • Assist with quality testing as directed by R&D, sales, or customers, • Help conduct hazard analyses for products, ingredients, and packaging, • Support preparation for customer and regulatory audits (CDPH, SQF, FDA), • Contribute to monthly quality reports, • Learning & Development, • Participate in ongoing training on food safety regulations and quality systems, • Stay informed about current food industry regulations and standards, • Develop proficiency in quality documentation and testing procedures, • Build knowledge of company products and manufacturing processes, • Team Collaboration, • Work closely with QC team on daily quality activities, • Support smooth product launches by coordinating with R&D team, • Maintain clean, organized, and safe work environment, • Perform other duties as assigned to support team goals, • QUALIFICATIONS, • Education (one of the following):, • Bachelor's degree in Food Science, Biology, Chemistry, or related field (recent graduates welcome), OR, • 1-2 years of Quality Assurance/Quality Control experience in food manufacturing, OR, • Willingness to complete the following certifications within first 6 months of employment:, • GMP certificate (online training provided), • Better Process Control School, • HACCP certification, • CDPH-recommended GMP training, • What We're Looking For:, • Strong attention to detail and desire to learn, • Good organizational and time management skills, • Team player with positive attitude, • Comfortable asking questions and seeking guidance, • Professional communication style, • Reliable and punctual, • Interest in food safety and quality systems, • WHAT WE OFFER, • Comprehensive training program with experienced mentors, • Opportunity to gain certifications in food safety and quality, • Hands-on experience with regulatory compliance, • Career growth potential within quality assurance Requirements Required Skills: • Basic proficiency in Microsoft Office (Word, Excel, Outlook), • Good written and verbal English communication skills, • Basic math skills (addition, subtraction, multiplication, division), • Valid driver's license, • Eagerness to learn and attention to detail Physical Requirements: • Ability to lift up to 40 pounds, • Ability to stand and/or sit for extended periods, • Willingness to taste and evaluate food products (may include common allergens) WORK AUTHORIZATION • Candidates must be authorized to work in the United States. Benefits • 401(k), • 401(k) matching, • Dental insurance, • Health insurance, • Life insurance, • Paid time off, • Vision insurance, • Pay: $24.00 - $27.80 per hour

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals LLC, Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834. About the Job: Title of the Position: Visual Inspection and Packing Operator At Nivagen, the Visual Inspection and Packaging Operator plays a critical role for performing manual visual inspection of products to ensure that defined quality standards are met. The role also involves operating manual and/or automatic leak testing machines and packing equipment to prepare products for shipment. The operator must perform activities related to sterile manufacturing, as and when required, and ensure that all operations are carried out in strict compliance with company policies, standard operating procedures, applicable regulatory requirements, and current Good Manufacturing Practices (cGMP), while upholding the highest standards of product quality and safety throughout the production process. Responsibilities: • To perform the visual inspection of the filled containers manually i.e., vials (liquid and lyophilised), pre-filled syringes, cartridges and IV bags., • To identify the defects i.e., Volume variation, particulate matter (such as glass pieces, any type of particles, fibres, etc.) Cosmetic defects (such as cap defects, sealing defects, label flaws, printed text matter flaws, external contamination, damage, wrong labelling, cross labelling flaws etc.) and shall ensure no defective product shall be supplied to the market., • Reconciliation and Segregation of the good and defective containers, preparation of defect library and preparation of Knapp/qualification kits required for the qualification of automatic inspection machines., • Assist and prepare documents (includes SOPs, batch records), protocols required for operation and maintenance of the VI, leak testing and packing equipment., • Responsible for handling, collection, transportation,and storage of the semi-finished and finished products as per product storage conditions and as per process requirements., • Responsible for avoiding cross-contamination and mix-up errors at various stages of operations., • Responsible for collaborating effectively with cross-functional departments to ensure timely coordination and organization of all prerequisites, supporting the smooth operation of the department and ensuring the delivery of finished products that meet market needs and business demands., • Qualification/validation of the equipment and area in accordance with approved protocols, and preparation and readiness for the routine commercial manufacturing., • The role requires the ability to stand, walk, and perform tasks for extended periods, lift and move products up to 35 kg, and demonstrate good hand-eye coordination and fine motor skills for inspection and packing duties., • The role requires good eyesight, strong attention to detail, the ability to identify defects or discrepancies, and a basic understanding of visual inspection and packaging requirements., • To perform in process, check and record details in documents in accordance with approved protocols, batch records, SOPs and regulatory guidelines., • Collaborate closely with production staff, including operators, supervisors, and cross-functional teams, to ensure product quality and timely delivery, while actively participating in team meetings and training sessions as required., • Packaging of products with secondary packing materials and packing them according to company specifications. Ensure packaging is sealed, labelled correctly, and checked for completeness and accuracy., • Perform various packaging operations such as labelling of carton/pouch, carton/pouch packaging, weighing of carton /pouch, printing and verification of batch details on carton/pouch, tertiary packaging as per packaging configuration and standards., • Collaboration with warehouse, production, In process quality teams for timely support and product deliverables to meet OTIF., • Adhere to safety guidelines, promptly report hazards or accidents, and ensure the work area remains clean and organized., • Involved in daily operations, including cleaning, maintaining logs, and overseeing routine visual /packing activities to ensure efficiency and compliance, • Tracking defect trends, maintaining control over defect storage, conducting periodic reviews, and implementing control and mitigation plans, • Assist and Managing market complaints, conducting investigations, implementing corrective actions, and preventing future occurrences., • Inventory management for the consumables required for the day to day packing activities., • Handling of Autoclave, Isolator and Filling machine as and when required., • Must be aware of clean room gowning., • Any other duties as directed by the supervisor. Education: • High school diploma or equivalent required; technical certification or degree in a related field is a plus. Experience: • 1-3 years of experience in pharmaceutical manufacturing, visual inspection, or packaging Knowledge and Skills: • cGMP, FDA regulations, and SOPs related to sterile and non-sterile pharmaceutical production., • Strong attention to detail and ability to detect visual defects., • Proficiency in operating inspection and packaging equipment., • Ability to follow written instructions and complete documentation accurately., • Good communication and teamwork skills. Requirements: • Legally authorized to be employed in the United States (U.S. citizens or national, permanent residents), • Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles' radius), • Able to successfully complete a drug and background check, • Stand, walk, and perform tasks for extended periods, lift and move products up to 35 kg, and demonstrate good hand-eye coordination and fine motor skills for inspection and packing duties., • Must comply with cleanroom protocols, gowning, and PPE requirements., • The role requires strong attention to detail, the ability to identify defects or discrepancies, a basic understanding of quality control and packaging requirements, the capacity to work efficiently in a fast-paced environment while maintaining high standards, and good manual dexterity for handling delicate products. Benefits: • Pay range $18 - $25 per hour, • Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, including medical, dental and vision coverage, • Paid time off plan, • 401 (k) savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Job DescriptionCompany Description Transforming Life Science Consulting Worldwide. Fusion Consulting is a globally leading Business and IT boutique consultancy specialized in the Life Sciences industry, partnering with leading companies in pharma, healthcare, and animal health. With over 450 employees and 25 offices worldwide, our mission is to revolutionize our clients' business transformation challenges and set new industry standards through innovative solutions. Focused on S/4HANA, Data & Cloud, and innovative technologies, Fusion Consulting brings unparalleled expertise and commitment to excellence to every project we undertake. Grounded in our commitment to fast and intelligent decision-making, our client-first and open-hearted approach defines our ethos. With unwavering support and an entrepreneurial spirit, our global teamwork transcends boundaries and turns shared visions into reality. At Fusion, we unite entrepreneurial minds from around the globe to develop and implement game-changing solutions that build lasting relationships with our clients. Job Description We are seeking a Senior IT/OT Infrastructure Project Manager to lead the implementation of a global OT domain supporting IT/OT separation, improved security, and centralized identity management in a regulated pharmaceutical environment. This role focuses on strengthening OT authentication, authorization, and infrastructure resilience, while enabling integration with enterprise IAM (MyAccess) and reducing reliance on legacy systems. Key Responsibilities: • Lead delivery of OT infrastructure projects supporting IT/OT domain separation, • Implement a global OT domain architecture aligned with security standards, • Improve and standardize authentication and authorization controls in OT, • Enable centralized OT user and resource management integrated with IAM (MyAccess), • Remove dependencies on legacy and end-of-life systems to increase resilience, • Manage stakeholders across IT, OT, Engineering, QC, Logistics, and Security, • Control project scope, timelines, risks, and deliverables, • Ensure compliance with GxP, IT security, and regulatory standards, • Provide executive reporting and lead steering committee meetings, • Maintain project documentation and governance standardsQualifications Required Skills & Experience: • 10+ years in IT/OT Infrastructure Project Management, • Strong understanding of IT/OT architecture, security, and identity management, • Experience with OT domain implementations and IAM integration, • Knowledge of infrastructure technologies (servers, firewalls, LAN/WAN, data centers), • Experience in the pharmaceutical industry (GxP, FDA), • Excellent stakeholder and vendor management skills, • PMP, Prince2, or equivalent certification, • Fluent in English Additional Information WHY YOU SHOULD JOIN FUSION: At Fusion, you’ll join a diverse team of talented professionals from around the world, united by a passion for delivering impactful digital transformation in the life sciences industry. You’ll be part of a flat-structured, collaborative organization where decisions are made efficiently, and your expertise directly shapes client outcomes. You’ll work alongside experienced consultants on complex, meaningful projects that demand both precision and innovation. Our culture emphasizes continuous learning, open knowledge sharing, and cross-functional teamwork—empowering you to grow both professionally and personally. Joining Fusion means becoming part of a company that: • Builds strong, trusted partnerships with clients, delivering tailored solutions that create real business value., • Drives delivery excellence, holding ourselves accountable for the quality and impact of every outcome., • Encourages entrepreneurial thinking, empowering you to take initiative, solve problems, and lead change., • Operates with a truly global mindset, where diverse perspectives, cultures, and collaboration fuel our success. WHAT WE OFFER - FUSION BENEFITS We’ve designed our benefits to support your growth, well-being, and global mobility. Growth & Development • Invest in Your Learning: Access annual budget for professional development., • Grow Your Skills: Join regular workshops and trainings to strengthen technical and soft skills., • Advance Continuously: Build the mindset, confidence, and capabilities to grow your career on your terms., • Shape an Inclusive Culture: Thrive in a workplace where your individuality is valued, and your voice drives meaningful change. Recognition & Reward • Earn What You’re Worth: Receive a competitive salary and benefits package that reflects your impact., • Refer Talent: Get rewarded for recommending new hires through our referral program., • Stay Rewarded: Access loyalty-based benefits starting from your third year via the Unity Scheme. Global Mobility & Local Support • Navigate Global Moves: Get help with visas, permits, and international assignments., • Benefit Locally: Enjoy perks tailored to your country of residence., • Collaborate Globally: Work in a diverse, inclusive culture where global teamwork drives success

Job DescriptionMore than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. The Associate, Packaging Operations and Cold Chain Handling - Night Shift supports critical operations related to the receipt of patient materials (leukapheresis/blood), cryopreservation of cellular products, and preparation and coordination of final drug product shipments. This role will operate with a deep understanding of GMP manufacturing, cell therapy processes, and the ability to execute multiple tasks in a fast-paced environment. Night Shift Hours Worked:• 6:00pm to 6:30am or• 6:30pm to 7:00am Work Week Schedule:• Sunday, Monday, Tuesday + every other Wednesday or• Thursday, Friday, Saturday + every other Wednesday Physical Demands • Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment., • Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.Work Conditions, • Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs., • Must be comfortable regularly participating in video-based meetings., • May be required to work scheduled overtime, weekends, or holidays based on business needs.Essential Duties & Key Responsibilities, • Blood Intake & Chain-of-Identity Management:, • Receive and verify incoming apheresis materials according to SOPs and regulatory requirements., • Perform visual inspections and documentation checks to ensure proper labeling, temperature, and packaging., • Maintain strict adherence to chain-of-identity and chain-of-custody procedures., • Cryopreservation Support:, • Assist in the preparation and cryopreservation of intermediate and final cellular products., • Operate and maintain cryogenic storage equipment (e.g., controlled-rate freezers, LN2 tanks)., • Accurately complete batch records and electronic documentation systems., • Drug Product Shipment:, • Coordinate the labeling, packaging, and final release of drug product for shipment., • Prepare shipping materials, confirm shipping conditions (e.g., temperature control), and liaise with logistics partners., • Ensure real-time data entry into inventory, tracking systems and eBRs, • Perform other duties as assigned, • Work closely with Quality Assurance, Supply Chain, and Manufacturing teams to ensure timely and compliant operations., • Support deviation investigations, CAPAs, and continuous improvement initiatives as needed., • Maintain accurate and complete records in accordance with GMP and GDP standards., • Good Manufacturing Practices (GMP) Training Minimum Qualifications, • Bachelor’s degree in Life Sciences, Engineering, or related field preferred., • 1-3 years of experience in a GMP-regulated biotech or pharmaceutical environment preferred., • Strong understanding of cell therapy manufacturing processes, • Strong attention to detail, organizational skills and document accuracy., • Ability to work with biological materials and cryogenic systems, • Knowledge of regulatory compliance (FDA and GxP) a plus, • Comfortable working in a clean room and or cold environment (Liquid Nitrogen storage) Travel Requirements and Work Environment, • Domestic and international travel not required, • May involve standing for extended periods and lifting up to 25 lbs, • Shift work, weekends, or holidays may be required depending on production needs, • Exposure to human blood products and temperature-controlled storage areas, • Gowning and use of Personal Protective Equipment required Base hourly pay range: $24–$26. The annualized earnings range above reflects estimated scheduled overtime and a +10% night shift differential. Total compensation will vary based on assigned shift, overtime worked, and applicable differentials.The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

Job DescriptionSalary: $35 - 40 per hour General Position Summary: This position is responsible for maintaining equipment performance as well as seeking improvement of line structure with TPM (Total Productive Maintenance) method. This position provides technical support for production equipment. It is also responsible for all compliance including food safety/hygiene and personal safety. The Maintenance Mechanic will perform duties which support the companys operational key indicators as well as verify all operations related maintenance to ensure OSHA, Personal safety, Product quality, FDA/USDA guidance, and SQF standards and specifications are met. Essential Job Functions • Adheres to maintenance programs and policies, and monitors the implementation in the areas of processing, warehouse, packaging, maintenance, and sanitation., • Conducts trainings of machine operation to employees including production and maintenance., • Organizes tools and materials. Ensures hazardous substance in containers locked and positioned properly in maintenance area., • Acts promptly when production line is down caused by machine failure., • Leads installation and repair of equipment or coordinates equipment repairs, installation, and building conditions with vendors. Reads schematic drawings if needed., • Sets up settings of each equipment and keep them only among limited personnel., • Also documents all settings of equipment and updates when there are changes., • Communicates with vendors for equipment., • Maintains and documents records of maintenance., • Leads a safety regulatory inspection., • Follow-up on corrective actions when machinery deviation occurs., • Participate on projects for continuous improvement., • Work with HR/Safety department to improve the work environment in personal safety., • Manages parts inventory and order them when necessary., • Pays close attention to detail. Essential Job Skills & Qualifications • 4+ years of experience in food production equipment maintenance and repair., • Knowledge and experience of food industrial equipment, Preventive maintenance and startup experience preferred., • Familiar with building code and OSHA regulation in California., • Knowledgeable of applicable software systems used in the schematic drawing such as AutoCAD, PLC and Microsoft applications (i.e. Word, Excel, and Outlook)., • The ability to review documents and to identify any errors or missing information and report corrections as needed., • The ability to work without supervision., • Ability to troubleshoot electrical 24v-480v., • Knowledge of motor controls - VDFs and contactors. Regular Schedule • Monday - Friday, 10:00pm - 6:00am, • Some Saturdays

Turing invites Healthcare and FDA Regulatory Law experts to join projects that fine-tune AI models like ChatGPT. You will apply your expertise in healthcare compliance, FDA drug/device approval, Anti-Kickback Statute analysis, and HIPAA enforcement to evaluate how AI handles healthcare regulatory sc