Associate Director, Product Technical Steward, Cell Therapy Technical Operations

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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.

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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.

Key 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.
• Key Deliverables: 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 
• Regulatory & Documentation: 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.
• Cross Functional Leadership: 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. 

Qualifications & Experience:

• 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 influen