Manager, Manufacturing New Product Introduction and Clinical Readiness
Bristol Myers Squibb
📍 Bothell, Washington, US0💼 Tempo pieno🕐 19 giorni fa
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Descrizione
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 .
Position Summary
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.
Duties/Responsibilities
Manufacturing Readiness & Technical Execution
• 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.
Technical Transfer & Program Coordination
• 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.
Risk Management & Compliance
• 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.
Cross-Functional Leadership
• 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.
Continuous Improvement & Operational Excellence
• 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.
Team Leadership & Development
• 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.
Qualifications
Specific Knowledge, Skills, Abilities:
• 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.
• Experience in facility startup, technology transfer, or large-scale program execution preferred.
Education/Experience/ Licenses/Certifications
• 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.
• Prior experience in cell therapy or biologics manufacturing preferred.
• Experience with technical transfer, manufacturing readiness, or process scale-up preferred.
BMSCART
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
Bothell - WA - US: $113,930 - $138,051
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/.
Benefits
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
• 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.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
• Eligibility Disclosure: T he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees i
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