Bristol Myers Squibb
Associate Director, Product Technical Steward, Cell Therapy Technical Operations
Bristol Myers Squibb, Madison, New Jersey, us, 07940
Associate Director, Product Technical Steward, Cell Therapy Technical Operations
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. 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. 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. 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. Regulatory & Documentation: Provide technical content for documents such as PPQ protocol or comparability assessments, author content for regulatory submissions and annual product quality review. 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. 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. Previous experience should be a combination of technical operation functions such as manufacturing, quality, MS&T (Technical operations) or Technical Development. Experience should include technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for Drug Product manufacturing and processing equipment. Compensation Overview: The starting compensation range(s) for this role are listed as $178,420 - $216,197 for Devens - MA - US and $166,740 - $202,055 for Madison - Giralda - NJ - US. Equal Employment Opportunity: BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
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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. 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. 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. 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. Regulatory & Documentation: Provide technical content for documents such as PPQ protocol or comparability assessments, author content for regulatory submissions and annual product quality review. 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. 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. Previous experience should be a combination of technical operation functions such as manufacturing, quality, MS&T (Technical operations) or Technical Development. Experience should include technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for Drug Product manufacturing and processing equipment. Compensation Overview: The starting compensation range(s) for this role are listed as $178,420 - $216,197 for Devens - MA - US and $166,740 - $202,055 for Madison - Giralda - NJ - US. Equal Employment Opportunity: BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
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