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Bothell, Washington, United States
Onsite
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
Position Summary
The Senior Specialist, Manufacturing NPI and Clinical Readiness, plays a key role in enabling clinical and commercial manufacturing readiness for cell therapy products through ownership of manufacturing documentation, MES recipe readiness and automation, change control impact assessment, clinical run coordination, risk assessments, and operator training.
This role operates with increased independence and technical breadth compared to entry‑level specialist roles, serving as a senior individual contributor who drives execution quality, coordinates across functions, and ensures manufacturing processes are clearly defined, executable, and inspection‑ready.
The Senior Specialist partners closely with Manufacturing Operations, MSAT, Quality, IT/MES, Engineering, and Supply Chain to support technical transfer, manufacturing readiness, and sustained operational performance at the JUMP Bothell site.
Duties/Responsibilities
Manufacturing Documentation & Readiness
Risk Assessments, Equipment & Process Readiness
Training & Manufacturing Execution Support
Clinical Run Coordination & Readiness Huddles
Cross‑Functional Support & Continuous Improvement
Reporting Relationship
Qualifications
o Advanced working knowledge of batch record development, SOP authorship, and GMP documentation practices.
o Hands‑on experience supporting MES/electronic batch record systems in a manufacturing environment.
o Strong understanding of aseptic or sterile manufacturing principles, preferably within cell therapy or biologics.
o Demonstrated ability to independently perform and document manufacturing risk assessments.
o Experience performing change control impact assessments and authoring or executing UAT for automated manufacturing recipes.
o Demonstrated ability to coordinate cross‑functional teams and lead operational huddles in support of clinical, engineering, and validation manufacturing runs.
o Strong technical writing skills and ability to translate complex processes into clear work instructions.
o Effective communicator with the ability to train operators and collaborate across functional teams.
o Proven ability to work independently, prioritize work, and manage multiple deliverables in a regulated environment.
o Bachelor’s degree in Engineering, Life Sciences, or related
technical field preferred or relevant years of experience. High School Diploma is required.
o 3–5 years of experience in a GMP‑regulated manufacturing environment.
o Prior experience with batch records, SOPs, manufacturing execution, MES systems, and operator training strongly preferred.
o Cell therapy or biologics manufacturing experience preferred.
SCHEDULE: Sun-Tuesday alternating Wednesday 8am-8pm
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:
Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
Supporting People with Disabilities
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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: 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/
For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.comwith the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.