Manager, Manufacturing New Product Introduction and Clinical Readiness
Bristol Myers Squibb
9 days ago
Remote friendly (Bothell, WA)
United States
Operations
Position Summary:
The Manager, Manufacturing NPI and Clinical Readiness, leads and coordinates cross-functional activities to ensure successful manufacturing readiness, technical transfer, and early lifecycle execution for cell therapy products. Owns key readiness deliverables (documentation, MES, training, risk management) and drives alignment across Manufacturing Operations, MSAT, Quality, Engineering, IT/MES, and Supply Chain.
Duties/Responsibilities:
- Lead end-to-end manufacturing readiness (documentation, MES recipe readiness, training, execution support).
- Ensure batch records, SOPs, and MES workflows are technically accurate, compliant, and aligned with process design/control.
- Coordinate readiness timelines for engineering runs, clinical manufacturing, and product launches.
- Provide on-the-floor support during manufacturing campaigns and tech transfer; resolve issues.
- Co-lead technical transfer; ensure alignment of process/facility/organizational readiness.
- Serve as primary cross-functional readiness point of contact; facilitate communication and decision-making.
- Track/communicate program status, risks, and key metrics.
- Lead cross-functional risk assessments (e.g., FMEA); define/track/execute mitigations.
- Identify/escalate risks impacting safety, product quality, or timelines; ensure cGMP and inspection readiness.
- Lead/represent Manufacturing NPI in Technical Product Teams; partner with QA/QC/MSAT/Regulatory/Engineering/IT-MES.
- Apply OPEX/lean to improve efficiency, documentation quality, and manufacturing reliability; improve MES usability and execution performance.
- Mentor specialists; may lead workstream/matrixed resources.
Qualifications:
- Bachelor’s/Graduate degree in Engineering, Life Sciences, or related field (required).
- 6+ years in a GMP-regulated environment (preferably biologics/cell therapy manufacturing) (required).
- Strong sterile manufacturing technology/processing knowledge.
- Strong equipment qualification/maintenance practices and GMP facility operations knowledge.
- Strategic/analytical thinking, problem solving, rapid decision-making.
- Proven success leading complex cross-department programs.
- Excellent communication; able to influence stakeholders.
- Preferred: facility startup, technology transfer, large-scale execution; prior cell therapy/biologics experience; technical transfer/manufacturing readiness/process scale-up.
Benefits (if explicitly stated):
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; 401(k); short-/long-term disability; life insurance; and work-life benefits including Paid Time Off.
Compensation Overview (if explicitly stated):
- Bothell, WA (US): $113,930 - $138,051.
Application instruction (if explicitly stated):
- If your resume doesn’t perfectly align, you are encouraged to apply anyway.
The Manager, Manufacturing NPI and Clinical Readiness, leads and coordinates cross-functional activities to ensure successful manufacturing readiness, technical transfer, and early lifecycle execution for cell therapy products. Owns key readiness deliverables (documentation, MES, training, risk management) and drives alignment across Manufacturing Operations, MSAT, Quality, Engineering, IT/MES, and Supply Chain.
Duties/Responsibilities:
- Lead end-to-end manufacturing readiness (documentation, MES recipe readiness, training, execution support).
- Ensure batch records, SOPs, and MES workflows are technically accurate, compliant, and aligned with process design/control.
- Coordinate readiness timelines for engineering runs, clinical manufacturing, and product launches.
- Provide on-the-floor support during manufacturing campaigns and tech transfer; resolve issues.
- Co-lead technical transfer; ensure alignment of process/facility/organizational readiness.
- Serve as primary cross-functional readiness point of contact; facilitate communication and decision-making.
- Track/communicate program status, risks, and key metrics.
- Lead cross-functional risk assessments (e.g., FMEA); define/track/execute mitigations.
- Identify/escalate risks impacting safety, product quality, or timelines; ensure cGMP and inspection readiness.
- Lead/represent Manufacturing NPI in Technical Product Teams; partner with QA/QC/MSAT/Regulatory/Engineering/IT-MES.
- Apply OPEX/lean to improve efficiency, documentation quality, and manufacturing reliability; improve MES usability and execution performance.
- Mentor specialists; may lead workstream/matrixed resources.
Qualifications:
- Bachelor’s/Graduate degree in Engineering, Life Sciences, or related field (required).
- 6+ years in a GMP-regulated environment (preferably biologics/cell therapy manufacturing) (required).
- Strong sterile manufacturing technology/processing knowledge.
- Strong equipment qualification/maintenance practices and GMP facility operations knowledge.
- Strategic/analytical thinking, problem solving, rapid decision-making.
- Proven success leading complex cross-department programs.
- Excellent communication; able to influence stakeholders.
- Preferred: facility startup, technology transfer, large-scale execution; prior cell therapy/biologics experience; technical transfer/manufacturing readiness/process scale-up.
Benefits (if explicitly stated):
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; 401(k); short-/long-term disability; life insurance; and work-life benefits including Paid Time Off.
Compensation Overview (if explicitly stated):
- Bothell, WA (US): $113,930 - $138,051.
Application instruction (if explicitly stated):
- If your resume doesn’t perfectly align, you are encouraged to apply anyway.