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This senior leadership role is responsible for driving enterprise‑wide quality compliance, regulatory readiness, and risk management across regulated pharmaceutical and life sciences operations. The position plays a critical role in shaping compliance strategy, ensuring sustained inspection readiness, and protecting patient safety through robust quality systems, strong governance, and proactive engagement with global Health Authorities. Job Duties • Provide enterprise leadership for quality compliance, governance, auditing, inspection readiness, escalation, and quality risk management, • Establish and execute a global quality compliance strategy aligned with cGMP, CFR requirements, global regulatory expectations, and HCLP considerations, • Maintain sustained inspection readiness across all sites, functions, and manufacturing modalities, • Lead interactions with FDA, DEA, and other global Health Authorities and defend compliance positions during inspections and audits, • Direct internal audit programs and manage all external audits, inspections, and notified body assessments, • Oversee DEA, DSCSA, and controlled substance compliance activities, • Own and manage the quality escalation framework and Notification to Management process, • Escalate significant quality events to executive leadership using structured quality risk management principles, • Ensure development, execution, and effectiveness of CAPAs addressing systemic and recurring issues, • Oversee enterprise quality management system processes, including document control, deviation management, change control, and supplier quality, • Develop, review, approve, and maintain quality policies, procedures, and compliance documentation, • Direct post‑market surveillance, adverse event reporting, and ongoing product performance monitoring, • Lead quality analytics, trending, and statistical monitoring activities across manufacturing, suppliers, and quality systems, • Apply predictive analytics and emerging technologies, including MasSpec, to proactively identify and mitigate compliance risk, • Partner with cross‑functional teams to drive continuous improvement while maintaining compliance independence, • Build, develop, and retain high‑performing quality and compliance teams, • Bachelor’s degree in pharmacy, chemistry, biology, chemical engineering, or a related scientific discipline, • 15 or more years of progressive experience in quality assurance, compliance, or risk management within regulated pharmaceutical or life sciences environments, • Senior‑level leadership experience within GMP‑regulated organizations, • Extensive knowledge of global GMPs, CFR requirements, ICH guidelines, DEA regulations, and quality risk management principles, • Demonstrated experience serving as a lead auditor and supporting regulatory inspections, • Strong understanding of enterprise QMS design, governance, and execution, • Experience with quality data analytics, trending, and applied statistics, • Familiarity with predictive quality tools, digital quality platforms, and advanced analytical approaches, • Proven ability to lead complex, global compliance initiatives and influence executive leadership, • Excellent written, verbal, and executive‑level communication skills, • Strong negotiation, stakeholder management, and decision‑making capabilities, • Ability to operate independently at a senior leadership level, • Willingness to travel approximately 40 percent for audits and inspections

Head of Quality Control (QC) FPC of Greensboro is working with a growing Pharmaceutical manufacturing client in their search for a Head of QC in their Sacramento, CA plant. This is a sterile injectable manufacturing site. We are seeking: -sterile/aseptic manufacturing experience -10+ years of leading a QC lab -LIMS experience -ability to lead and build a team Relocation assistance is available, as well as excellent salary, benefits, and growth potential. Please contact Will Martin for more information.

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: Technician We are seeking a dedicated and experienced Technician to join our team at Nivagen. In this key role, you'll be responsible for operating and maintaining our HVAC system, BMS and EMS system ensuring they function safely, efficiently, and reliably. This position is pivotal in minimizing downtime and supporting our manufacturing operations' overall productivity and efficiency. Responsibilities: • Operate and maintain HVAC system , BMS, EMS and supporting areas observing all safety procedures and regulations., • Monitor HVAC systems to detect malfunctions and necessary maintenance., • Perform routine inspection and maintenance on HVAC systems to ensure optimal operation., • Record and maintain daily logs on HVAC operations, maintenance, and safety activities., • Coordinate with the maintenance team to implement repairs and improvements., • Adhere to all environmental policies and procedures, ensuring compliance with legal regulations., • Should have knowledge on the clean room classification , AHU zoning , pressure balancing and other operation related to AHU and its area of supply., • Preventative maintenance of HVAC systems, • Prepare the SOP / EOP for the system., • Ability to lean other system and operate them., • Follow Good documentation practices Education/Experience: • High School Diploma or equivalent, • HVAC Systems & Components: Knowledge of heating, ventilation, air conditioning, refrigeration systems, and related components (furnaces, heat pumps, etc.)., • Electrical & Mechanical Expertise: Proficiency in wiring, circuit boards, motors, and other mechanical systems used in HVAC., • Troubleshooting & Diagnostics: Ability to efficiently diagnose and resolve HVAC system issues using diagnostic tools., • Installation, Repair, & Maintenance: Skilled in installing, repairing, and maintaining HVAC components and systems., • Customer Service & Communication: Strong skills in explaining issues and maintaining professional client relationships., • Energy Efficiency & Sustainability: Awareness of energy-efficient HVAC systems and eco-friendly practices., • Safety & Compliance: Knowledge of building codes, safety regulations, and adherence to industry standards (e.g., OSHA, EPA)., • Valid driver's license and acceptable driving record, • Legally authorized to be employed in the United States (U.S. citizens or national, permanent residents), • Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius), • Able to successfully complete a drug and background check, • Pay range $25.0 - $32.0 per hour (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 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.

Head of Quality Control (QC) FPC of Greensboro is working with a growing Pharmaceutical manufacturing client in their search for a Head of QC in their Sacramento, CA plant. This is a sterile injectable manufacturing site. We are seeking: -sterile/aseptic manufacturing experience -10+ years of leading a QC lab -LIMS experience -ability to lead and build a team Relocation assistance is available, as well as excellent salary, benefits, and growth potential. Please contact Will Martin for more information.

Pharmaceutical Program Manager — Contract Location: Sacramento / Greater Sacramento Area, CA (On-Site Preferred) Engagement Type: Contract Consulting (6 Months, with Strong Extension Potential) Level: Mid-Level Project Manager and Senior Project Manager openings available Start: As soon as available The Opportunity A well-established contract development and manufacturing organization (CDMO) operating in the pharmaceutical and biotech space is seeking experienced Pharmaceutical Program Managers for project-based contract engagements at its California facility. This site supports small molecule drug development and manufacturing programs for a global portfolio of pharmaceutical and biotech clients. This is an embedded, on-site role — you will be fully integrated with the site team, managing active customer programs end-to-end while serving as the primary interface between the client and the internal manufacturing, quality, and R&D functions. Multiple openings exist across mid-level and senior levels, making this an opportunity for program managers at various stages of their careers. What You'll Do • Manage customer programs from kickoff through completion — own overall program scope, schedule, budget, and contractual requirements; maintain ongoing customer relationships post-project completion, • Serve as the primary customer interface — represent the organization to pharmaceutical and biotech clients; manage communications, expectations, and escalations with professionalism and technical credibility, • Coordinate cross-functional execution — integrate activities across R&D, manufacturing, quality assurance, analytical testing, procurement, and finance to ensure programs stay on track and on budget, • Support business development — contribute to proposal development and new project submissions; participate in customer visits, tours, and presentations alongside the commercial team, • Proactively manage risk — identify program risks early, assess their impact on timelines and outcomes, and implement mitigation strategies throughout the project lifecycle, • Drive schedule and issue resolution — help the project team meet milestones, resolve technical or operational problems, and keep multiple simultaneous programs moving forward, • Contribute to financial forecasting — participate in program-level forecasting of awards, margins, and sales as part of site business planning, • Upskill site team members — senior candidates in particular will help develop and coach junior program management staff on-site Who You Are Senior Level (5–8+ years of experience): • 5–8 years of pharmaceutical, biotech, or CDMO program/project management experience, • Bachelor's degree in Chemistry, Engineering, or a related science discipline (Master's or PhD with fewer years of experience also considered), • Proven track record managing complex, multi-stakeholder pharmaceutical programs — ideally in a CDMO or contract manufacturing environment, • Comfortable as the customer-facing lead; able to manage client expectations and resolve issues with confidence and clarity, • Strong cross-functional coordination skills — able to align R&D, QA, manufacturing, and commercial teams toward a common program goal, • 2–5 years of experience in pharmaceutical, biotech, or related technical program/project coordination, • Bachelor's degree in Chemistry, Engineering, or related science required, • Exposure to pharma manufacturing workflows, quality systems, or customer-facing program support, • Highly organized, detail-oriented, and comfortable managing multiple tasks simultaneously, • Strong written and verbal communication skills — able to interact effectively across all levels of management and with external customers, • Ability to manage multiple programs simultaneously without sacrificing quality or attention to detail, • Experience or comfort working in a site-based, on-site team environment Engagement Details • Location: Sacramento/Greater Sacramento area, CA — on-site presence strongly preferred; candidates within commuting distance are ideal; candidates willing to be on-site the majority of the week (e.g., from the Bay Area or nearby regions) may also be considered

Kelly® Science & Clinical is seeking a Quality Management Systems Specialist for a direct hire opportunity with a leading specialty pharmaceutical company in Sacramento, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries. Workplace: Onsite in Sacramento, CA. Position Title: Quality Management Systems Specialist, Sterile Drug Products Position Type: Direct hire Salary Range: 70,000-80,000/year Benefits: • Yearly bonus eligibility, • Our client 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 Overview Step into a vital leadership role in Sacramento’s vibrant life sciences sector. We’re seeking a proactive Quality Assurance QMS Specialist with expertise in parenteral drug products to champion our continuous improvement and compliance initiatives. Drive CAPA excellence, mentor operational teams, and play a critical part in safeguarding product quality, patient safety, and regulatory readiness. Your Impact: As a QMS Specialist, you’ll be at the forefront of our parenteral manufacturing quality system—collecting and analyzing information to identify, mitigate, and prevent quality and product issues. You’ll collaborate closely with the Site Quality Lead Team and mentor site personnel, ensuring effective root cause analysis and robust corrective and preventive actions. By cultivating best practices in deviation, change control, and CAPA, your work will directly enable superior product performance, process improvements, and regulatory success. What You’ll Do: • Lead and coach operations and cross-functional teams in Change Control, Deviation Management, and CAPA programs—building a strong culture of quality and ownership., • Drive rigorous investigations, root cause analyses, and implementation of corrective and preventive actions to eliminate recurring issues in sterile product manufacturing., • Design, manage, and sustain a site-wide CAPA program, collaborating with function owners to proactively capture both existing and potential quality risks., • Compile and present CAPA program metrics to the Site Quality Lead Team, delivering actionable insights and improvement plans., • Ensure timely and thorough completion of deviations and CAPAs, with close monitoring and rapid escalation of overdue or complex events., • Act as lead instructor, educating site teams on Change Control, Deviation Management, and CAPA best practices., • Coach lead investigators on technical writing to increase rigor, accuracy, and compliance in documented investigations., • Serve as a Subject Matter Expert and primary author for site CAPA and Deviation Management procedures and periodic reviews., • Initiate and support site-wide quality investigations, trends analysis, and technical improvement projects., • Foster a deep understanding among site personnel of how the CAPA program drives product/process improvement and compliance., • Benchmark and implement best-in-class practices in collaboration with the network deviation program mentor., • Lead and optimize the implementation of the electronic Quality Management System (eQMS) across departments. What You Bring: • Bachelor’s or Master’s degree (Life Sciences or Engineering preferred), or equivalent experience in a GMP-regulated environment, • 3+ years of experience in GMP pharmaceutical or parenteral manufacturing (Quality Assurance or Engineering roles preferred), • In-depth knowledge of cGMP, FDA regulations (21 CFR), and sterile manufacturing quality systems, • Strong proficiency with electronic QMS platforms and CAPA systems, • Demonstrated expertise in root cause investigation, deviation management, and change control, • Exceptional communication and interpersonal skills—able to explain, influence, and lead across all levels of the organization, • Ability to thrive under pressure, make sound judgments, and lead independently with minimal supervision, • Skilled at managing multiple priorities and tasks in a dynamic environment Preferred Skills: • Experience authoring technical CAPA/deviation documentation and leading process audits or regulatory inspections, • Strong organizational, time-management, and analytical abilities, • Flexibility to work variable hours and provide shift or weekend coverage as business demands, • Play a meaningful role in the growing Sacramento life sciences cluster, supported by stellar research institutions and a collaborative local biotech community, • Build your expertise and make a tangible difference in the quality and safety of high-impact injectable medications, • Thrive in a culture committed to professional growth, operational excellence, and patient-focused outcomes Ready to elevate your quality career and drive innovation at the forefront of Sacramento’s pharmaceutical industry? Apply today and lead the way in parenteral QMS excellence!

Automation Technician We are hiring an Automation Technician to support a growing pharmaceutical manufacturing operation in the Sacramento area. This is a hands-on, high-impact role where you will be responsible for keeping automated production systems running in a sterile, regulated environment. The team is looking for someone who can troubleshoot, maintain, and support equipment with minimal supervision. What You’ll Be Doing • Troubleshoot and maintain production equipment (motors, pumps, sensors, drives), • Support automation systems including PLCs, HMIs, and SCADA, • Calibrate instrumentation (pressure, temperature, flow, pH, etc.), • Perform electrical work including wiring, conduit, and panel modifications, • Support commissioning and validation activities (IQ/OQ/PQ), • Maintain clean utility systems (WFI, clean steam, HVAC, HEPA), • Read and interpret schematics, wiring diagrams, and P&IDs, • Document all work in compliance with GMP and FDA standards What we're looking for • 5–10 years of hands-on experience in manufacturing or industrial environments, • Strong troubleshooting skills across electrical, mechanical, and instrumentation systems, • Experience working with sensors, transmitters, and control systems, • Ability to read technical drawings and schematics 📩 Apply directly or message me for more details

Kelly® Science & Clinical is seeking a Document Control & Training Manager for a Direct Hire position at a leading specialty pharmaceutical company in Sacramento, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts. Salary: $80-90k Overview: In this role, you will lead and mentor teams to manage document control and GMP training programs, ensuring regulatory compliance and inspection readiness, driving digital transformation, supporting cross-functional collaboration, and fostering a culture of continuous improvement and operational excellence within a fast-growing pharmaceutical and biotech organization. Schedule: Monday-Friday, standard working hours Responsibilities: • Lead and Develop Teams: Direct, mentor, and inspire the Document Control and GMP Training teams, fostering growth, accountability, and continuous improvement., • Set Strategic Direction: Establish KPIs, objectives, and overall strategy for document control and training in alignment with organizational quality goals., • Champion Regulatory Compliance: Ensure robust document management and training programs meet global regulatory requirements (21 CFR 210/211, EU GMP) and maintain inspection readiness., • Oversee Document Lifecycle: Supervise the creation, organization, revision, archival, and retrieval of critical documents such as SOPs, Master Batch Records, and logbooks for multi-product/multi-site operations., • Manage GMP Training Programs: Oversee employee training curricula, ensuring all staff are qualified, compliant, and prepared for evolving processes or regulatory changes., • Drive Process Improvement: Proactively identify workflow bottlenecks, elevate document control best practices, and implement scalable solutions across the organization., • Lead Digital Transformation: Act as the Business System Owner for electronic document and training management systems, overseeing system configuration, validation, and integrity per regulatory standards (21 CFR Part 11)., • Support Audits and Inspections: Represent quality systems during FDA/EMA audits, regulatory inspections, and customer visits, and deliver improvement strategies to leadership., • Collaborate Cross-Functionally: Work closely with QA, Manufacturing, Regulatory, IT, and Engineering teams to drive seamless quality operations and support remediation efforts as needed., • Uphold Culture and Standards: Set clear policies and productivity benchmarks, promote ethical practices, and cultivate a strong culture of operational excellence and compliance company wide. Qualifications: • Bachelor’s degree in Science, Engineering, or related field, Master’s degree strongly preferred., • 8+ years of QA experience in a GMP-regulated environment., • 3+ years of people management experience., • Extensive knowledge of cGMP (21 CFR 210/211), EU GMP, GDP, 21 CFR Part 11, and ALCOA data integrity principles., • Demonstrated expertise as a Business System Owner for digital Document Control/Training systems., • Proven experience supporting successful regulatory inspections and customer audits., • Superior project management, change leadership, and communication skills.

• Candidates Must Reside in the Greater Sacramento, CA Area* Purpose and Scope Under limited supervision, the AMR-UO is responsible for achieving sales objectives in assigned territory through the development, maintenance, and enhancement of the business. These customers include oncologists, urologists, nurses, pharmacists, pharmacy and therapeutics groups, teaching institutions, private and federal hospitals and formulary committees. The AMR-UO is responsible for ensuring customer's clinical conviction in the product and seeing the sale through to its conclusion by providing sufficient training and ongoing customer service. The AMR-UO will develop territory business plans and work with the sales management team to maximize the impact of sales and marketing plans and tactics. Essential Duties & Responsibilities • Develop and maintain business relationships with targeted physicians, health care providers and customers focusing on the promotion of Tolmar products, • Create, maintain and increase sales within designated territory by influencing the prescribing habits of the targeted audience., • Call on health care providers and health-related organizations within assigned territory., • Strategically identify and develop relationships with non-prescribing health care providers that influence decision making in accounts such as CEOs, CFOs, Nurse Navigators, injecting nurses, Medical Assistants, office managers and personnel, etc., • Understand impact of local purchasing coalitions, Group Purchasing Organizations, IDNs and other health organizations in geography., • Provide community oncology practices, private and group urology practices and private and federal hospitals with contracting, training, technology troubleshooting and ongoing customer service., • Identify practice needs for Tolmar's proprietary Inventory Management System and manage the implementation as well as ongoing training within accounts., • Communicate and partner regularly with other AMRs to successfully manage accounts that overlap across multiple geographies., • Evaluate and monitor sales data reports weekly to manage business needs promptly and effectively., • Demonstrate advanced business acumen and granular account acumen management skills, • Communicate contract measurement details to accounts when necessary, ie quarterly or semi-annually., • Follow up on leads among offices that have expressed interest in learning more about the Company's products., • Convert potential leads to active users, and provide or arrange for necessary training of those offices., • Demonstrate thorough knowledge of products by effectively communicating appropriate clinical, technical, therapeutic, disease state and product information to customers., • Successfully promote the appropriate on-label use of approved products., • Develop and deliver informative sales presentations based on individual customer needs to maximize sales of the product portfolio., • Maintain up-to-date database to document sales call information, trends, future call objectives, sampling data and overall territory performance., • Complete routine reports and be compliant with industry, regulatory and company guidelines., • Prepare annual business plans and conduct quarterly analysis of the territory performance vs. plan., • Attend and represent the Company at trade shows and community events, as appropriate., • Attend and travel for Company meetings., • Manage usage and inventory of promotional items to be given away to offices., • Abide by Administrative Expectations as defined by AMR SOPs: Submit expense reports regularly as outlined, enter sales calls in CRM system daily or as indicated by Regional Sales Director, enter company car mileage weekly, maintain company car as required by Fleet Maintenance., • Manage promotional budget effectively and in a compliant manner., • Manage relationships internal and external of the Company to support pull through of business., • Partner with different departments in the Company as the business requires., • Abide by the Company's email and communication SOPs., • Perform various other duties as assigned., • Regular and punctual attendance is an essential function of the job. It is expected that our sales force is "in the field" calling on customers from 8:00am to 5:00pm each day. Knowledge, Skills & Abilities • Knowledge of Microsoft Office products including Outlook, Word, PowerPoint and Excel., • Excellent interpersonal, written and verbal communication skills., • Excellent analytical skills and proven strategic thinker., • Advanced Skill in organization and follow-up., • Skill in negotiation and selling techniques with demonstrated accountability in executing sales plans., • Aptitude for learning technical and scientific product relation information., • Highly motivated for success with a "can do" attitude., • Ability to work independently., • Ability to manage multiple projects both inside and outside the organization., • Ability to work with multiple interruptions and tight deadlines., • Ability to execute effective business plans for assigned territory., • Ability to develop working relationships with both internal and external customers and work as a team player with employees at all levels., • Ability to take initiative in the absence of precise direction., • Ability to demonstrate good judgment, discretion and compliance to industry ethical guidelines., • Demonstrates assertive selling techniques including asking for business on every call. Core Values Tolmar's Core Values: • Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together., • Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes., • Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace., • Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality., • Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future. Education & Experience • Bachelor's degree in science, business or related field., • Two or more years of successful business-to-business sales experience, preferably in the urology industry., • Pharmaceutical/buy-and-bill sales experience preferred, • Clinical experience helpful., • Consistent track record of exceeding sales quotas, • Ability to be approved and insured to drive company car including valid driver's license and good driving history, • Reside centrally within the territory. Working Conditions • Office environment; requiring sitting and standing., • Overnight travel is required up to 50%., • Ability to lift 50 pounds., • Travel by air as required., • Availability to work extra hours and on weekends as necessary. Compensation Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience. The pay range for this position at commencement of employment is expected to be between: • <3 years of experience with proven sales results: $115,000-$130,000, • 2-5 years of experience with proven sales results: $120,000-$140,000 About Tolmar Tolmar is proud to have earned a reputation for performance and innovation. Through a progressive company culture, Tolmar has established a legacy as a trusted name in the research, development and manufacturing of high quality topical products used in dermatology, and extended release dosing forms for products commonly used in urology and oncology. Founded in 2006, we are a private company known internationally for our advanced drug delivery capabilities and our unmatched commitment to our partners, and to the patients and provider communities we serve. Since our inception, Tolmar has produced 22 marketed products supported by 5 New Drug Applications (NDAs) and 17 Abbreviated New Drug Applications (ANDAs) across urology and oncology and dermatology. With more products forthcoming, our dedicated pipeline reflects Tolmar's future-focused approach. Tolmar offers exciting opportunities that will leverage your abilities, expand your skills, and reward your contributions in an atmosphere that encourages both personal and professional growth. Additionally, Tolmar offers competitive compensation and excellent benefits including: • Competitive and inclusive medical, dental and vision coverage options, • Flexible Spending Accounts for medical expenses and dependent care expenses, • HSA through our HDHP, • CompleteCare reimburses you and your dependents for eligible health care expenses and premium expenses incurred under alternate group health coverage, • Generous 401K match - currently match 100% of your contributions up to the first 6% of compensation and 50% from 7%-12%, but never greater than 9%, • Tolmar-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options, • Employee Assistance Plan, Legal Guidance and Funeral Planning & Concierge Services, • Adoption and family-planning benefits, Fertility and Family Forming Benefits, • Generous paid time off, including:, • Vacation, sick time and holidays, • Volunteer time to participate within your community Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the ___ notice from the Department of Labor.

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 Technician, Facilities/Maintenance - Night Shift is responsible for supporting the maintenance and repair of facilities and associated infrastructure across multiple production sites producing clinical and commercial drug products. This role involves utilization of a Computerized Maintenance Management System (CMMS) to execute and document preventative and corrective maintenance activities to ensure compliant and reliable operations to support production requirements to meet customer needs. 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 Job Duties and Key Responsibilities • Perform or coordinate preventive and corrective maintenance on the facility and associated infrastructure, • Coordinate onsite preventative and corrective maintenance to be completed by service providers, • Escort of service providers in restricted access areas during execution of facility and asset maintenance activities, • Review and approval of service provider documentation, and completion of tasks in the CMMS, • Maintain documentation in accordance with company standards, • Ensure that facilities and associated infrastructure are maintained to applicable regulatory and GMP requirements, • Participate in the continuous improvement of facility standards, specifications, procedures, and business processes, • Other duties as assigned, • Respond to emergency maintenance requests during off-hours as neededEducation & Experience Requirements, • High school diploma or GED required, associate’s degree or certification in facility maintenance preferred, • 2 years of experience in GMP manufacturing facility, preferably cell therapy, biotechnology or pharmaceutical, • Experience in use of a CMMS system for managing execution of maintenance activities, • Experience in execution of preventative and corrective maintenance of a GMP manufacturing facility and associated infrastructure, • Experience coordinating onsite maintenance activities completed by service providersPersonal Qualities & Physical Demands, • Ability to multitask and manage multiple responsibilities simultaneously; able to prioritize, • Demonstrates strong work ethic and problem-solving skills, • Willing to support sites after-hours on an as needed or on-call basis, • Strong people skills and ability to communicate effectively, • Ability to gown and work in cleanroom areas, • Ability to work in a collaborative manner, independently and as part of a team, • Ability to work in a fast-paced start-up environment while following documented procedures and instructions.

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 Facility Coordinator 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. The Facility Coordinator works closely with other departments to support the overall goals of the organization. This will be an onsite role (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: 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:, • 3-5 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. You will also be eligible to receive pre-IPO equity, 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.

This Jobot Job is hosted by: Amanda Preston Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $110,000 - $135,000 per year A bit about us: We are a global leader in scientific testing, inspection, and advisory services, supporting the world’s most innovative pharmaceutical and biotechnology organizations. Our teams partner with clients across the product lifecycle, from early development through commercialization, delivering high-quality, data-driven solutions that support regulatory compliance and patient safety. With a strong reputation for technical excellence and a collaborative, client-focused approach, we provide an environment where scientific expertise and innovation come together to solve complex challenges in regulated industries. Why join us? This is an opportunity to work at the intersection of pharmaceuticals and medical devices, supporting cutting-edge combination product programs that directly impact patient outcomes. You will collaborate with cross-functional teams and leading organizations in the industry while contributing to high-visibility, regulatory-critical initiatives. We offer a dynamic environment where you can expand your technical expertise, take ownership of meaningful projects, and play a key role in shaping best practices across combination product development and quality systems. Job Details We are seeking a highly motivated engineer or scientist with experience in combination products and/or medical devices to support design control, risk management, and regulatory compliance activities. This individual will play a key role in ensuring that development programs meet global regulatory standards while advancing innovative drug-device products. Key Responsibilities Lead design control and risk management activities for combination product development programs, ensuring all deliverables are properly authored, reviewed, and maintained to support clinical and commercial milestones Support and facilitate risk management activities with external design partners and manufacturing sites Ensure all development activities align with applicable quality and regulatory standards, both internal and external Provide input into design validation activities, including human factors and usability engineering assessments Evaluate external design partners and suppliers to ensure quality systems, facilities, and processes meet development and production requirements Support investigations related to device design and manufacturing for clinical and commercial products Contribute to the development of regulatory submission content for device and combination product programs Participate in internal and external audits of quality management systems Identify opportunities for continuous improvement within combination product systems and processes Collaborate across cross-functional teams to support broader organizational initiatives Qualifications Bachelor’s, Master’s, or PhD in a relevant scientific or engineering discipline (e.g., Chemistry, Biology, Biomedical Sciences, Mechanical Engineering, Materials Science, Chemical Engineering, or related field) Experience within pharmaceutical combination products and/or medical device industries Strong knowledge of applicable regulations and standards including ISO 13485, ISO 14971, ISO 9001, 21 CFR 820, 21 CFR Part 4, and EU MDR Experience with design controls and device risk management processes Familiarity with Human Factors Engineering and Usability Engineering principles Working knowledge of standards such as EN 62366, EN 60601, and EN 62304 Understanding of device assembly and manufacturing processes Experience performing complex data analysis to support engineering and quality decisions Familiarity with Good Manufacturing Practices (GMP) Skills and Competencies Strong project management capabilities with the ability to provide technical leadership High attention to detail with a focus on accuracy and quality Ability to manage multiple priorities and work across concurrent projects Capable of working independently with minimal supervision Strong collaboration skills within cross-functional teams Excellent communication skills, both written and verbal Proficiency in standard business software (Word, Excel, PowerPoint) Ability to quickly learn and apply established procedures in a consistent and reliable manner Interested in hearing more? Easy Apply now by clicking the "Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. 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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 Manager, Manufacturing Science and Technology (MSAT) is responsible for leading Manufacturing Science and Technology process engineers, across several shifts, within the commercial manufacturing site. This role oversees the day-to-day MSAT operations to support clinical and commercial production, deviations, product impact assessments, change controls, CAPAs, risk assessment, tech transfer and continuous improvement of manufacturing processes and technologies to ensure product quality, efficiency and compliance with regulatory standards.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:, • Lead a small team of engineers and technical experts, • Provide leadership and guidance in technical decision-making related to manufacturing operations, • Manage review and approval of quality records owned or supported by MSAT, • Implement process improvements based on data analysis and scientific principles, • Lead efforts in production excellence to support commercial scalability and compliance, • Support the transfer of processes from R&D into GMP manufacturing facilities, • Collaborate with cross functional teams to trouble shoot and resolve technical issues Minimum Qualifications:, • B.S. in Engineering, Chemistry, Pharmacy or related scientific discipline required, • 6+ years of industry experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries, • 3+ years of people leadership experience, • Prior experience in regulated, GMP manufacturing operations, • Strong communication and problem-solving skillsPreferred Qualifications:, • Masters or PhD in Chemical Engineering, Biochemistry or Biology is preferred, • 2 to 4 years of leadership experience preferred

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 Education/Experience: • Doctor of Pharmacy (Pharm.D.) degree from an accredited institution, • 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., • 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, • 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, • 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 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. 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 Manager, Commercial Manufacturing oversees the daily operations within our GMP manufacturing facility. This individual will manage the production of cell-based therapies, ensuring adherence to regulatory guidelines, standard operating procedures (SOPs), and quality standards. The successful candidate will play a pivotal role in delivering patient batches with a high degree of safety, quality and reliability while mentoring and guiding a team of Supervisors and support Cell Therapy Production Associates, Oncology. 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:, • People leadership: Supervise and manage manufacturing staff including supervisor and operators to ensure timely execution of production batches. Coach and develop talent and train team members on SOPs, aseptic techniques, and safety protocols., • Execution of Manufacturing Activities: Responsible for coordinating production execution activities to meet production schedules and deliver products to quality standards, reliably and on time. Manage deviations, corrective and preventative actions and change controls and drive continuous improvements in manufacturing execution., • Compliance & Quality Assurance: Ensure all manufacturing execution activities comply with industry standards and regulations (e.g., GMP, ISO). Work closely with the quality team to ensure that batch manufacturing meets product quality and safety requirements. Drive needed corrective and preventive actions., • Continuous Improvement Culture: Foster a culture of continuous improvement within the organization, encouraging employees to contribute ideas, solve problems, and implement solutions that drive improvement in execution. Drive manufacturing improvements in communication, manufacturing flow and batch execution., • Cross-Functional Collaboration: Work closely with MSAT, engineering, quality, and supply chain teams to drive daily activities and ensure execution to manufacturing schedules. Facilitate communication between teams to ensure execution to safety, quality and reliability of batch production., • Employee Safety: Promotes a safety-first culture reinforcing a mindset of safety as integral to product quality and patient outcomes. Ensure employee compliance with safety regulations. Enforce the use of personal protective equipment (PPE), sterile gowning protocols, and ergonomic practices., • May require shift, weekend, or holiday coverage to support manufacturing and patient treatment timelines.Minimum Qualifications:, • Bachelor's degree in a relevant field such as Biotechnology, Engineering, Manufacturing or Operations Management; advanced degree preferred., • 3-5 years of experience in GMP cell therapy, biologics, or pharmaceutical manufacturing environment, • 2-4 years in a people leadership or supervisory role., • Deep understanding of aseptic processing, closed system operations and cell therapy techniques., • Excellent analytical, problem-solving, and decision-making skills., • Organizational, interpersonal and communication skills. Preferred Qualifications: • Masters or PhD in Chemical Engineering, Biochemistry or Biology is preferred, • 5+ years of leadership experience preferred, • Experience in Cell therapy manufacturing preferred, • Experience with regulatory inspections and cGMP compliance preferred.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. You will also be eligible to receive pre-IPO equity, 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. Summary of Position: The Calibration Technician is responsible for inspecting, testing, calibrating, and maintaining measurement and test equipment to ensure accuracy and compliance with industry standards and company quality requirements. The Calibration Technician works closely with other departments to support the overall goals of the organization.Key Responsibilities: • Perform calibration, adjustment, and repair of equipment used in GMP Production and Quality Control Lab testing (mechanical, electrical, electronic, and dimensional)., • Maintain calibration records in accordance with quality standards (ISO, ANSI, NIST, etc.)., • Utilize and maintain a Computerized Maintenance Management System (CMMS) to accurately track, plan, and document asset calibration, repairs, and inventory, ensuring data integrity for regulatory compliance., • Troubleshoot equipment performance issues and recommend corrective actions., • Ensure all Calibration Standards meet required tolerances and specifications., • Author and update calibration procedures., • Assist with internal and external audits., • Maintain a clean and organized calibration lab., • Coordinate with production and engineering teams to minimize downtime.Qualifications:, • Associate degree or technical certification in Electronics, Engineering Technology, or related field (or equivalent experience)., • 4 years of calibration experience in a GMP environment, preferably in the cell therapy, biotechnology or pharmaceutical manufacturing facility., • Strong knowledge of measurement principles and standards (ISO 9001, ISO/IEC 17025 preferred)., • Experience with Calibration Standards such as multimeters, temperature sensors pressure gauges, torque tools, tachometers, calipers, and other precision instruments., • Experience with GMP regulatory standards, and documenting work per GDP requirements., • Ability to read technical drawings and schematics., • Strong attention to detail, documentation, communication, and interpersonal skills., • Proficiency in Microsoft Office, maintenance management, and calibration management software., • Familiarity with NIST traceability requirements., • Strong problem-solving and analytical skills., • Ability to work independently and as part of a team., • The position requires on-site presence and typically involves regular hours but may require on-call availability and after-hours presence for planned or unplanned work, or emergency response., • Gowning for cleanroom access., • Ability to lift up to 40 lbs.

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. You will also be eligible to receive pre-IPO equity, 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. 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 Associate, Cell Therapy Handling and Cryopreservation 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. 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.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 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. You will also be eligible to receive pre-IPO equity, 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 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. 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

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: SAP Master Data and Support Analyst (Full Time) The SAP Master Data and Support Analyst ensures accurate, complete, and consistent master data in SAP for PAI and provides SAP support to users. Reporting to the Director-SAP, they maintain and update SAP master data records, collaborate with cross-functional teams to ensure data quality, analyze and identify data issues, and provide support on usage of different modules in SAP. They contribute to improved usage of SAP by supporting internal stakeholders and continuously improving our processes. Responsibilities: • Create and manage the process of creation and collection of master data (excluding customer and vendor master), • Enforce the process for master data creation and changes, • Coordinate the process of collection of master data for materials, recipes/ BOMs, and verification by data owners, • Review the finalized master data and get sign-off from data owners before the setup in SAP, • Execute changes to SAP master data following business approvals, • Perform mass updates as needed with business approvals, • Conduct periodic review of master data (typically monthly), to ensure accuracy and completeness, • Work with business units and process experts to resolve master data issues, • Provide SAP support to users to resolve issues in production (including compounding and packaging), warehouse material movement, and customer service activity. It is critical to provide timely support to users, to understand the nature of the issue, whether it is a user error, a master data issue, or a bug that is affecting usage., • Conduct SAP training regularly for existing employees and new employees, by maintaining an SAP training calendar for modules in SAP MM, WM, QM and PP areas., • Update, assist, and/or write SOPs that are required to help the users to properly use the system Participate in projects and initiatives across multiple functional areas relating to improvements in the usage of SAP, and how master data is managed * Ensure data quality, compliance, and consistency of master data across business systems, * Provide technical and functional expertise in SAP master data, and train users Education/Experience: • Degree in IT, Computer Science, or similar level of experience and knowledge, • SAP Configuration experience in modules (MM/WH/PP) is a distinct advantage, • Strong ability to work independently and manage one's time, and be a collaborative team member., • 2+ years' experience in master data management, preferably in manufacturing/ pharma,, • Strong Microsoft Office suite skills, able to understand and investigate topics related to multiple business areas., • Knowledge of production, warehousing, quality, serialization and EDI, and supporting different functions in some capacity is highly desirable., • Experience and knowledge of different master data elements like BOMs, recipes, Quality info records, purchasing info records, etc., • Strong analytical and problem-solving skills, • This position requires the individual be organized, detail-oriented, and self-motivated. Standard office equipment is used., • High level of attention to detail, particularly in identifying quality deviations and documenting production processes, • Strong understanding of GMP, FDA regulations, and other relevant pharmaceutical industry standards 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 $70,304 - $85,000 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 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 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 Inc., 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 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., • 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)., • Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius), • Cleanroom and sterile production areas with controlled environments., • Competitive salary, • 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 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. Position Summary:The Specialist, EHS is responsible for supporting the development, implementation, and maintenance of environmental, occupational health, and workplace safety programs and policies to ensure compliance with local, state, and federal regulations and multiple sites. Location: Sacramento, CA (on-site). This role is primarily based at our "Sac02" commercial manufacturing facility on Metro Air Parkway (3–4 days per week), with regular time at our nearby "Sac01" site on Business Drive (1–2 days per week). Occasional travel to our Bay Area (Menlo Park) headquarters may be required (1–2 days per month).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.Key Responsibilities, • Ensure compliance with Cal/OSHA, EPA, DTSC, CDPH and other applicable regulatory standards, • Conduct safety audits, inspections, and risk assessments to identify and mitigate safety, health, and environmental risks. Coordinate implementation of identified corrective actions or improvements., • Lead safety committees and represent EHS interests in cross-functional meetings and project teams., • Develop, coordinate, and deliver EHS training programs for employees (HazCom, LOTO, PPE, emergency response, etc.), • Investigate near-misses, incidents, and injuries, and recommend and track corrective actions. Manage associated documentation and reporting requirements., • Develop, maintain and update EHS policies, procedures, and documentation, • Manage environmental programs including waste management, air emissions, and wastewater compliance, • Manage the proper handling, storage, disposal, documentation, and regulatory compliance of biohazardous and hazardous wastes, • Track and report safety metrics and environmental data, • Support emergency preparedness and response planning, • Collaborate with leadership to drive continuous improvement in safety performance, • Maintain EHS documentation, including SDSs, permits, and reporting., • Lead or support emergency response plans, drills, and preparedness activities.Qualifications, • Bachelor’s degree in Environmental Science, Occupational Health & Safety, Industrial Hygiene, or related field preferred., • 5 years of EHS experience in a GMP environment, preferably in a cell therapy, biotechnology or pharmaceutical manufacturing facility., • Working knowledge of Cal/OSHA, EPA, DTSC, CDPH and other relevant regulations, • Excellent leadership, communication, and interpersonal skills., • Excellent project and time management skills with the ability to manage multiple priorities in a fast-paced environment, • Strong analytical, attention to detail, and problem-solving skills, and ability to make sound decisions, • Certifications such as OSHA, HAZWOPER, CSP or CHMM are a plus., • This 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.

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 Engineer, MSAT works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions. 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.Essential Duties & Key Responsibilities:, • Performs ongoing monitoring of existing commercial products and processes, • Generate metrics and reports for process monitoring and continuous process verification, • Support process improvements and changes including electronic batch record creation and modifications, • Performs Out of Trend Investigations based on trends from process monitoring, • Provides troubleshooting support for manufacturing events, equipment performance and material issues, • Performs root cause analysis to isolate cause of events and determine appropriate corrective actions, • Authors and owns change controls, technical protocols, reports and activities to support process improvements, • Writes and ensures proper execution of validation protocols and testing in line with required life cycle management activities, • Leads design, project management and execution of MSAT projects, introduction of new materials, and equipment at multiple GMP facilities, • Assess potential impact of supplier changes, material changes, Drug product labels, Drug Product packaging and cold chain transport changes and excursionsMinimum Qualifications:, • B.S. in Engineering or similar fields, • 3+ years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries, • Prior experience in regulated, GMP manufacturing operations, • Experience with data analysis and trending using JMP or other statistical software, • Follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition Preferred Qualifications:, • Experience in biotechnology and cell therapy manufacturing preferred, • Experience with commercial packaging, labeling, and cold chain strongly preferred

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. You will also be eligible to receive pre-IPO equity, 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 DescriptionAre You Ready?CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard—through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our Purpose We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. Our Foundational Principles- At CAI, we are committed to living our values—both professionally and personally:- We act with integrity- We serve each other- We serve society- We work for our future- We are relentless in our dedication to excellence, pushing boundaries and redefining industry standards. We thrive at the intersection of wisdom, technology, and humanity—always focused on how it will be done, not how it used to be done. Key Responsibilities1. Technical Responsibilities- Develop documentation for CQV activities- Write and execute protocols (field verification)- Develop summary reports at client sites2. Areas of Focus- Pharmaceutical facilities- Utilities- Equipment3. Project & Team Management- Plan and coordinate work- Direct small teams in document development and/or execution Qualifications and Experience- Bachelor’s degree in a science or engineering field (or equivalent experience)- 2–4 years’ experience in commissioning and qualification in a regulated industry- Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus- Preferred experience in:- Facilities and equipment startup- Walk-downs and troubleshooting- Utilities (WFI, RO, HVAC)- Upstream/downstream processing- Purification, recovery- Building automation- Pharmaceutical manufacturing processes Critical CompetenciesInfluence Strategy- Pursues initiatives aligned with organizational strategy- Identifies strategic, innovative solutions- Anticipates emerging customer/market needs Satisfy the Customer- Understands and anticipates customer needs- Delivers high-quality solutions and service- Proactively maintains satisfaction and loyalty Plan for Success- Aligns business strategies with actionable plans- Anticipates risks and builds contingency plans- Secures resources for goal achievement Pursue Execution- Prioritizes time and resources effectively- Holds self and others accountable- Acts to overcome obstacles and improve quality Tailor Communication- Communicates clearly and professionally- Adjusts style to fit the audience- Explains technical concepts effectively Build Partnerships- Builds networks across functions- Encourages collaboration and breaks down silos- Involves stakeholders in decisions Influence Others- Builds support with sound rationale- Gains buy-in from decision makers- Encourages innovative thinking Develop Self and Others- Enhances interpersonal relationships- Models integrity and company values- Seeks out growth and breakthrough opportunities#LI-MV1Average base salary range - not including benefits, and potential overtime and Cost of Living Adjustment. CAI Benefits:•Comprehensive Health Insurance coverage•24 days of Paid Time Off•ESOP/401K - 15% Company Contribution (US Only)•Company paid Life Insurance•Company paid Long Term DisabilityWe are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO). We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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. 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., • 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., • 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 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 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., • 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., • 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., • 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., • Oversee design, execution, and monitoring of stability studies in compliance with ICH guidelines., • 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., • 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. 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., • Pay range: Competitive Salary Range 150k - 165k 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 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 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: Training and Document Control Manager The Training and Document Control Manager provides strategic and operational leadership for the Document Control and GMP Training functions within the Quality Management System (QMS). This role ensures the organization maintains an inspection-ready, compliant, and scalable document management and training program aligned with cGMP (21 CFR 210/211), EU GMP, and applicable global regulatory requirements. The Manager serves as a key Quality Systems leader, partnering cross-functionally to drive process standardization, digital system optimization, change management, and continuous improvement initiatives while fostering a strong quality culture. Responsibilities: * Leadership & Strategic Oversight • Lead and mentor the Document Control and Training teams, fostering accountability, transparency, and professional growth., • Establish department objectives, performance metrics, and continuous improvement initiatives aligned with Quality strategy., • Act as a strategic partner to Quality Leadership in both short-term execution and long-term QMS planning., • Drive inspection readiness and serve as a visible leader during regulatory inspections and customer audits., • Oversee the global Document Control program to ensure compliance, scalability, and data integrity., • Ensure proper organization, lifecycle management, archival, and retrieval of controlled documents., • Lead the review, approval, and processing of SOPs, Master Batch Records, Protocols and reports, Forms and templates, • Ensure timely issuance of document numbers, logbooks, batch records, and quality record identifiers., • Maintain workflow oversight to drive on-time document review and approval., • Evaluate and improve document control processes to support multi-product and multi-site operations., • Manage and enhance the site GMP Training Program to ensure regulatory compliance and workforce competency., • Ensure training curricula align with controlled document changes and organizational change management., • Partner with functional leaders to ensure appropriate assignment and completion of role-based training., • Monitor training compliance metrics and address overdue or non-compliant training events., • Serve as Business System Owner (BSO) for electronic Document Management and Training Systems (e.g., ComplianceWire, eInfoTree)., • Oversee system configuration, metadata management, access controls, and periodic reviews., • Support QMS system enhancements, validation (CSV), and digital transformation initiatives., • Lead requirement-gathering sessions for system improvements and scalability., • Ensure alignment with cGMP, GDP, 21 CFR Part 11, EU GMP, and applicable regulatory standards., • Support regulatory inspections, internal audits, and customer audits related to document control and training., • Provide QMS metrics and reports to support Management Review., • Collaborate cross-functionally (QA, Manufacturing, Regulatory, IT, Engineering) to ensure consistent quality process execution., • Support remediation activities, including high-volume SOP updates under accelerated timelines., • Directly manage and develop Document Control and Training personnel., • Set performance goals and conduct regular performance evaluations., • Develop policies, procedures, and productivity standards., • Allocate resources and prioritize workload to meet business needs., • Foster cross-functional collaboration and effective communication across departments., • Bachelor's degree in Science, Engineering, or related technical discipline (Master's degree preferred)., • Minimum 8–10 years of experience in Quality Assurance within a GMP-regulated pharmaceutical or biotech environment., • 3–5 years of direct people leadership experience., • In-depth knowledge of:, • cGMP (21 CFR Parts 210/211), • EU GMP, • Good Documentation Practices (GDP), • 21 CFR Part 11, • ALCOA and Data Integrity, • Demonstrated experience as Business System Owner for electronic Document Control and/or Training systems., • Experience supporting regulatory inspections and audits., • Strong organizational, analytical, and strategic planning skills., • Excellent written and verbal communication skills., • Strong understanding of pharmaceutical regulations, including FDA, EMA, GMP, and ICH guidelines, • Proficient in data analysis with the ability to interpret complex quality data and identify trends, • High level of accuracy and attention to detail, particularly in documentation and data analysis, • Demonstrated ability to conduct root cause analysis and implement effective CAPAs, • Excellent written and verbal communication skills, with the ability to prepare clear and concise reports and documentation, • Familiarity with QMS software and other relevant tools used in quality management and data analysis, • The role involves working in both office and manufacturing environments, requiring adherence to safety protocols and GMP standards, • Occasional travel may be required for audits, supplier evaluations, or training, • Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles' radius) Additional Information: • Flexibility is required as work hours and start times may vary to provide coverage on different shifts to meet business needs., • Overtime and weekend work may be required., • Pay range Competitive, • 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 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. 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 MSAT Process Engineer works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions. We are multiple positions across the following schedules: 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., • 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.Responsibilities, • Performs ongoing monitoring of existing commercial products and processes, • Generate metrics and reports for process monitoring and continuous process verification, • Support process improvements and changes including electronic batch record creation and modifications, • Investigates process events and implements corrective and preventive actions, • Provides troubleshooting support for manufacturing events, equipment performance and material issues, • Performs root cause analysis to isolate cause of events and determine appropriate corrective actions, • Authors, executes and owns change controls, technical protocols, reports and activities to support improvements, • Writes and ensure proper execution of validation protocols and testing in line with required life cycle management activities Education & Experience Requirements, • B.S. in Engineering or similar fields, • 3+ years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries, • Prior experience in regulated, GMP manufacturing operations, • Experience in biotechnology and cell therapy manufacturing preferred, • Strong communication and problem solving skills, with a desire to improve upon established processes This position is eligible for 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. You will also be eligible to receive pre-IPO equity, 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 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: Quality Assurance QMS Specialist - Parenteral At Nivagen as a Quality Assurance QMS Specialist - Parenteral, you will be responsible for supporting the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with regulatory requirements and industry standards. This role involves analyzing quality data, managing documentation, coordinating audits, and driving continuous improvement initiatives to ensure the highest standards of product quality and regulatory compliance within the pharmaceutical industry. Responsibilities: * Responsible for collecting and analysing information to identify actual and potential product and quality problems, to work with the Site Quality Lead Team to take appropriate and effective corrective and preventive actions, and to verify and validate the effectiveness of CAPA. • Leads, mentors, and coaches operations and support personnel on the Change control, deviation management system, and CAPA program., • To drive complete root cause investigations and ensure assignment of corrective and preventive actions to eliminate the root causes of a detected issue or other undesirable situation to prevent recurrence., • Create and maintain the CAPA program, through working cross-functionally with all area/function owners to include data sources that identify existing as well as potential problems., • Compile and present CAPA program health metrics to the Site Quality Lead Team with proposed actions., • Monitor deviation and CAPA performance to ensure investigations and associated CAPA are completed promptly., • Act as a site instructor for Change Control, Deviation Management, and CAPA courses., • Coaches lead investigators on technical writing., • Authors periodic reviews and acts as Subject Matter Expert for site CAPA and Deviation Management procedures., • Supports and initiates deviations, trends, or other technical investigations, as applicable., • Engages site personnel in the relationship between the CAPA program and resulting product and process improvement and enhanced product and process understanding., • Works with the network deviation program mentor to benchmark and replicate best practices., • Effective implementation of the electronic Quality Management system (eQMS) across organisations. Qualifications: Education/Experience: • A Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, or Related Sciences from an accredited institution is preferred, • Strong understanding of pharmaceutical regulations, including FDA, EMA, GMP, and ICH guidelines, • Proficient in data analysis with the ability to interpret complex quality data and identify trends, • High level of accuracy and attention to detail, particularly in documentation and data analysis, • Demonstrated ability to conduct root cause analysis and implement effective CAPAs, • Excellent written and verbal communication skills, with the ability to prepare clear and concise reports and documentation, • Familiarity with QMS software and other relevant tools used in quality management and data analysis, • The role involves working in both office and manufacturing environments, requiring adherence to safety protocols and GMP standards, • Occasional travel may be required for audits, supplier evaluations, or training, • Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles' radius) Additional Information: • Flexibility is required as work hours and start times may vary to provide coverage on different shifts to meet business needs., • Overtime and weekend work may be required., • 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 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. 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, Production Project Support supports the execution and documentation of business process improvements, change controls, CAPA initiatives, and the development and maintenance of Standard Operating Procedures (SOPs). This role works cross-functionally with production, quality assurance, engineering, and continuous improvement teams to ensure timely and compliant execution of changes and improvement projects within a regulated manufacturing environmentPhysical 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, • Assist in the identification, documentation, and implementation of business process improvements to enhance efficiency, quality, and cost-effectiveness., • Coordinate data collection and analysis to support root cause investigations and improvement initiatives., • Support the preparation, tracking, and execution of change control documentation in compliance with quality and regulatory standards., • Ensure all impacted stakeholders are involved in the review and approval of changes., • Maintain accurate records of change implementation and outcomes., • Support the execution and documentation of corrective and preventive actions, including follow-up activities., • Assist in CAPA investigations by compiling data, organizing cross-functional meetings, and tracking completion of action items., • Ensure CAPA documentation meets internal and regulatory expectations., • Draft, revise, and maintain SOPs in collaboration with subject matter experts., • Ensure SOPs reflect current best practices and regulatory requirements., • Facilitate training rollout and ensure personnel are informed of updated procedures., • Track progress of ongoing production-related projects and report on milestones, issues, and risks., • Schedule and facilitate cross-functional meetings as needed to support project deliverables., • Maintain accurate and organized project documentation., • On-site presence required, especially during critical project phases or production support., • May involve gowning and working in classified cleanroom environments, including no jewelry, makeup, etc., • Occasional off-hours or weekend work depending on project needs.Minimum Qualifications, • Bachelor’s degree in Life Sciences, Engineering, or related field., • 2+ years of experience in a GMP-regulated biotech or pharmaceutical environment., • Strong understanding of cell therapy, biotech or pharmaceutical manufacturing processes, • Proven track record of successfully implementing improvement projects, • Excellent communication, leadership, and organizational skills.Preferred Qualifications, • Project management knowledge is a plus., • PMP Certification or equivalent formal project management training is preferred, • Familiarity with Lean Six Sigma or operational excellence methodologies is a plus, • Knowledge of FDA, EMA, and global regulatory expectations for advanced therapy medicinal products is preferred.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. You will also be eligible to receive pre-IPO equity, 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 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. Education/Experience: • Experience in assisting in preparing reports and writing documents., • 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 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 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: QMS Associate As a QMS Associate at Nivagen, you are responsible for coordinating and supporting the lifecycle management of deviations within the Quality Management System (QMS). This role ensures timely documentation, investigation support, root cause analysis facilitation, and CAPA tracking in compliance with cGMP, FDA regulations, and internal quality standards. The Associate works cross-functionally with Manufacturing, Engineering, QC, and Validation teams to ensure quality events are appropriately investigated, documented, and closed within established timelines. Responsibilities: • Manage the intake, triage, and processing of deviations within the electronic Quality Management System (eQMS)., • Perform initial impact and risk assessments to determine deviation classification and required investigation level., • Coordinate cross-functional investigations to ensure timely root cause analysis and documentation., • Support the development, tracking, and effectiveness verification of Corrective and Preventive Actions (CAPAs)., • Ensure deviations are investigated and closed within established timelines and escalate overdue records as necessary., • Review investigation reports for completeness, technical accuracy, regulatory compliance, and data integrity., • Identify recurring trends and support periodic reporting on quality metrics., • Participate in Quality Risk Assessments (e.g., FMEA) related to deviations and product impact evaluations., • Support regulatory inspections and internal audits by providing deviation records and investigation summaries., • Maintain compliance with cGMP (21 CFR Parts 210/211), data integrity principles, and company quality procedures., • 0–3 years of experience in pharmaceutical, biotech, or regulated manufacturing environments., • Basic knowledge of cGMP and FDA regulations (21 CFR)., • Familiarity with deviation management, CAPA systems, and root cause analysis tools preferred., • Strong understanding of sterile manufacturing processes, aseptic techniques, environmental monitoring, and contamination control principles., • Experience with TrackWise electronic Quality Management Systems preferred., • Strong analytical and problem-solving skills., • Excellent written and verbal communication skills., • Strong attention to detail and organizational skills., • Understanding of risk management principles (ICH Q9)., • Exposure to investigation methodologies (5-Why, Fishbone, Fault Tree Analysis)., • Ability to interpret manufacturing, laboratory, and validation data., • Experience supporting FDA inspections or internal audits., • The role involves working in both office and manufacturing environments, requiring adherence to safety protocols and GMP standards, • Occasional travel may be required for audits, supplier evaluations, or training, • Pay range $70,304 - $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 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 Associate, Cell Therapy Handling and Cryopreservation - 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

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 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 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.

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