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Senior Field Application Scientist at Cell Signaling Technology, serving as a technical liaison for EMEA customers in cell therapy. Delivering expert support, ensuring regulatory compliance, and driving market success in biopharmaceuticals.
About the role
- Associate Director developing harmonized CQV strategies across Cell Therapy network for equipment and systems. Ensuring regulatory compliance and optimal validation processes across internal and external manufacturing sites.
Responsibilities
- Establish strategy and deliver optimized and harmonized CQV approaches across the Cell Therapy network.
- Work collaboratively with Cell Therapy network Digital Plant and BMS enterprise qualification L2 to synthesize guidance in standards for qualification of equipment with internal computer systems.
- Oversight of Cell Therapy equipment validation execution across network, ensuring lifecycle management of the standardized approach.
- Responsible for ensuring all regulatory and GxP compliance items related to Validation are satisfied, maintaining all sites in an inspection-ready status.
Requirements
- B.S., M.S., or Ph.D. in Mechanical Engineering, Chemical Engineering, or related scientific/engineering discipline.
- 15+ years w/ B.S. or 12 years w/ M.S. or 8 years w/ Ph.D. of experience in biologics or cell therapy GMP manufacturing support.
- Strong understanding of CMC regulatory requirements, DS & DP manufacturing, and analytical testing.
- Excellent strategic thinking, problem-solving, decision-making, and communication skills.
- Strong knowledge of ICH guidelines, control strategies, and validation lifecycle frameworks.
- Ability to effectively utilize project management and Lean Six Sigma tools is a plus.
- Excellent interpersonal, collaborative, team building, and communication skills.
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. 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.
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