Manager, Manufacturing New Product Introduction and Clinical Readiness

Bristol Myers Squibb • Bothell, WA

9h • Hybrid

About The Position

The Manager, Manufacturing NPI and Clinical Readiness, is responsible for leading and coordinating cross-functional activities to ensure successful manufacturing readiness, technical transfer, and early lifecycle execution for cell therapy products. This role bridges technical execution and program leadership by owning key readiness deliverables (documentation, MES, training, and risk management) while driving alignment across Manufacturing Operations, MSAT, Quality, Engineering, IT/MES, and Supply Chain. The Manager operates with a high degree of independence, serving as a functional lead for discrete programs or workstreams, ensuring processes are scalable, inspection-ready, and aligned with clinical and commercial manufacturing objectives.

Requirements

• Bachelor’s or Graduate degree in Engineering, Life Sciences, or related field required.
• 6+ years of experience in a GMP-regulated environment, preferably in biologics or cell therapy manufacturing.
• Strong technical knowledge of sterile manufacturing technology and processing techniques.
• Strong understanding of equipment qualification, maintenance practices, and GMP facility operations.
• Strong strategic and analytical thinking, problem solving, and rapid decision-making skills.
• Proven success in leading complex programs or projects across multiple departments.
• Excellent communication skills, with the ability to influence and align stakeholders.

Nice To Haves

• Prior experience in cell therapy or biologics manufacturing preferred.
• Experience with technical transfer, manufacturing readiness, or process scale-up preferred.
• Experience in facility startup, technology transfer, or large-scale program execution preferred.

Responsibilities

• Lead end-to-end manufacturing readiness activities for assigned programs, including documentation, MES recipe readiness, training, and execution support.
• Ensure batch records, SOPs, and MES workflows are technically accurate, compliant, and aligned with process design and control strategies.
• Coordinate readiness timelines across functions to support engineering runs, clinical manufacturing, and product launches.
• Provide on-the-floor support during key manufacturing campaigns and tech transfer phases to ensure successful execution and rapid issue resolution.
• Support and co-lead technical transfer activities, ensuring alignment of process, facility, and organizational readiness across stakeholders.
• Act as a primary point of contact for cross-functional readiness activities, facilitating communication, issue resolution, and decision-making.
• Track and communicate program status, risks, and key metrics to stakeholders and leadership.
• Lead cross-functional risk assessments (e.g., FMEA) and ensure mitigation strategies are defined, tracked, and executed.
• Identify and escalate risks that may impact safety, product quality, or manufacturing timelines.
• Ensure all readiness activities align with cGMP expectations and inspection readiness standards.
• Lead or represent Manufacturing NPI within Technical Product Teams, driving execution of technical plans and readiness strategies.
• Partner with QA, QC, MSAT, Regulatory, Engineering, and IT/MES to resolve technical and compliance issues.
• Influence decisions through technical expertise and data-driven recommendations.
• Apply OPEX and lean principles to improve process efficiency, documentation quality, and manufacturing reliability.
• Identify opportunities for process optimization and scalability during technical transfer and early lifecycle manufacturing.
• Contribute to initiatives improving MES usability, documentation robustness, and execution performance.
• Provide guidance and mentorship to senior specialists and specialists, supporting technical development and execution consistency.
• May lead workstream teams or matrixed project resources to deliver program objectives.
• Promote a safety-first and quality-driven culture across all activities.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager