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        Principal Engineer, Cell Therapy Tech Ops
- Bristol Myers Squibb (Seattle, WA)
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             Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . We are seeking a highly motivated and detail-oriented MSAT Engineer to support AAV (Adeno-Associated Virus) and gene editing manufacturing processes involving CRISPR/Cas systems and RNP (ribonucleoprotein) complexes activities at external Contract Manufacturing Organizations (CMOs). This role is critical for ensuring robust tech transfer, process monitoring, troubleshooting, and continuous improvement of AAV production processes. The ideal candidate will have hands-on experience with upstream and downstream AAV manufacturing, CRISPR/Cas9 or Cas systems, RNP formulation, electroporation, and cell therapy manufacturing, with a strong understanding of GMP operations and analytical technologies. Key Responsibilities: + **Tech Transfer & Process Support** + Lead and support tech transfers of AAV and gene editing manufacturing processes to CMOs. + Support PPQ strategy, planning, and execution for products. + Support process development and scale-up of RNP delivery methods. + Author and review process documentation including protocols, batch records, and tech transfer packages. + Collaborate with internal process development and quality teams to ensure alignment with specifications, process control strategies and CMO capabilities. + Monitor critical process parameters and ensure consistency across batches. + Analyze process data to identify trends and drive improvements in yield, efficiency, and product quality. + **Manufacturing Oversight** + Provide technical oversight during manufacturing campaigns, including on-the-floor and remote support during PPQ and routine production. + Monitor critical process parameters and performance metrics. + Troubleshoot deviations and support root cause investigations. + **Process Improvement** + Analyze manufacturing data to identify trends and opportunities for optimization. + Support implementation of process changes and scale-up activities. + Evaluate new technologies and equipment for improved process robustness. + **Documentation, Compliance & Regulatory Support** + Ensure compliance with GMP and regulatory requirements. + Support preparation of regulatory filings (e.g., IND, BLA) with process descriptions and data. + Participate in audits and inspections as a technical SME. + Contribute to regulatory filings (e.g., IND, BLA) with process descriptions and validation data. + Participate in audits and inspections as a technical SME. + **Cross-Functional Collaboration** + Act as a liaison between internal stakeholders and CMO teams. + Work closely with QA, QC, Regulatory, and Supply Chain to ensure seamless execution of manufacturing campaigns. Required Qualifications + B.S., M.S., or Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related discipline with: + **10+ years (B.S.)** , **8+ years (M.S.)** , or **5+ years (Ph.D.)** of experience in biologics or cell therapy process development, tech transfer, or GMP manufacturing support. + Demonstrated success leading **late-stage development, PPQ strategy, and commercial validation.** + Proven track record managing and influencing **external partnerships (CDMOs/CMOs)** to achieve strategic outcomes. + Strong knowledge of **ICH guidelines, control strategies, and validation lifecycle frameworks.** + Experience authoring and defending **regulatory submissions** (INDs, BLAs, variations). + Ability to influence **senior stakeholders** and align cross-functional teams on complex technical and strategic issues. + Proficiency in **data analytics and modeling tools** (e.g., JMP, R, Minitab). + Exceptional communication skills with the ability to **translate complex technical content into strategic recommendations** for leadership. Preferred Qualifications + Expertise in **cell therapy, immunotherapy, or viral vector manufacturing.** + Experience shaping and executing **global strategy** across multiple manufacturing sites. + Prior involvement in **global governance forums** or steering committees. + Familiarity with advanced statistical and QbD approaches for **process lifecycle management.** If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Seattle - WA: $164,020 - $198,759 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected] . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1596367 **Updated:** 2025-10-31 05:34:30.044 UTC **Location:** Seattle 400 Dexter-WA Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. 
 
 
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                    Principal Engineer, Cell Therapy Tech Ops
                
                - Bristol Myers Squibb (Seattle, WA)