Associate Director, Product Technical Steward, Cell Therapy Technical Operations

Bristol Myers Squibb•Devens, MA

2d•$166,740 - $216,197•Hybrid

About The Position

The Associate Director, Product Technical Steward, Cell Therapy Technical Operations (CTTO) is highly cross-functional and challenging, involving leadership across all sites of Drug Product manufacture for the designated product. In this role the Technical Steward will: Develop strategy for the product franchise by representing Drug Product on product strategy teams and leading a cross-functional team that manages the Drug Product technical project portfolio. Be the primary owner of the Drug Product process, and leads or participates in process validation, regulatory filings, regulatory inspections and responses, technology transfers, troubleshooting, change management, process monitoring and robustness, continuous improvement, and other initiatives. Interact regularly with product development to ensure process readiness for commercialization, assess resources required, communicating progress and risks, and presenting timelines and strategies for endorsement. Represent the Drug Product manufacturing process in regulatory interactions such as inspections and other meetings. Work with Drug Product manufacturing site teams to troubleshoot manufacturing issues and develop process improvements. Collaborate closely with analytical, quality, regulatory, operations, development, supply chain, program strategy, third-party manufacturing, and manufacturing sciences to drive the franchise strategy. The position requires resolution of complex problems through strong leadership of cross-functional teams to meet product quality, schedule, and cost objectives.

Requirements

B.S/MS/PhD in Chemical Engineering or Biology, Chemistry, Biochemical (Life Science) with 12+ years of relevant experience in the biopharmaceutical company with most of that experience demonstrating progression of technical leadership responsibilities and scope.
Previous experience should be a combination of technical operation functions such as manufacturing, quality, MS&T (Technical operations) or Technical Development.
Should have excellent communication skills and be able to strategically influence the direction of the company in the scope areas mentioned above.
Experience should include technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for Drug Product manufacturing and processing equipment, manufacturing support and technology transfer.
Ability to define the right processes for the team’s maturity level, balancing agility and discipline.
Prior experience in leading cGMP investigations utilizing formal Root Cause Analysis tools strongly preferred.
Ability to assess risk and develop contingency plans for process risks.
Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities.
Detail oriented with excellent verbal and written communication skills.
Strong interpersonal and leadership skills to work with teams in different functions and organizations.
Experience leading regulatory inspections regarding tech transfer, validation and extensive knowledge of regulations, current industry practices.
Should have demonstrated the skill to lead large, complex technical organizations with a global scope and build processes, and technology in a growing organization.
Proven project management skills (organization, collaboration, multi-tasking, and communication), attention to detail, and the ability to perform well in a team-based environment are required

Nice To Haves

2-3 years of experience in cell therapy process development and or manufacturing.
Combination of experience in process development, MS&T and quality, experience with manufacturing automation systems/platform.

Responsibilities

Strategic Planning: Defines strategy for the product franchise by representing Drug Product on product strategy teams and leads a cross-functional technical team that creates and governs the Drug Product technical project portfolio for the designated product.
Technical Oversight: Collaborate with process development and analytical development to ensure early pipeline assets have a robust process.
Primary owner of the Drug Product process for the designated product.
Technical content and strategy across tech transfers, process validation, technical reports, data analysis, process monitoring, change control and implementation, product comparability and escalated support of technical/scientific process and analytical issues
Provide technical content for documents such as PPQ protocol or comparability assessments, author content for regulatory submissions and annual product quality review, present technical strategies during major health authority interactions and inspections.
Collaborates closely with analytical, quality, regulatory, operations, development, supply chain, strategy, third party manufacturing and manufacturing sciences roles to drive the brand strategy and prevent supply disruptions.
Lead efforts focusing on alignment and harmonization of manufacturing process across multiple sites.
Oversees implementation of lifecycle management projects and responsible for gaining consensus on change implementation strategies that ensure robust Drug Product supply.

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.

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