Associate Director, Product Steward Technical Lead
- Summit, NJ
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS's continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.
Product Steward / Technical Product Team (TPT) Lead
We are looking for a Vector Product Steward / Technical Product Team (TPT) Lead to join our Vector and Gene Delivery team in the Global Manufacturing & Technology group here at Bristol Myers Squibb.
Come, join the BMS Cell Therapy Development and Operations (CTDO) Division, and be a part of the team building leading cell therapy platforms to serve our patients with novel cellular immunotherapies.The Global Manufacturing Science and Technology (GMS&T) Division of CDTO plays a critical role in technology transfers, process validation, CMC life cycle management, technical oversight of external and internal manufacturing partners, process engineering and establishing manufacturing standards to enable a robust and scalable global cell therapy manufacturing network.
We are looking for a Product Steward / TPT Lead to join our Vector and Gene Delivery MS&T group in Global MS&T to serve as the lead for vector manufacturing for one of our commercial CAR-T products. The position is located in Summit, NJ.
The TPT Leader is a key member of the Global Operations (GO) Team and is responsible to develop and deliver on the CMC strategy while ensuring that the strategy aligns with the overall brand and functional strategies. The TPT success will be measured by maintaining supply continuity, meeting customer service targets, successfully achieving regulatory approval of the technical agenda elements, and achieving process robustness milestones. The TPT Leader will also work closely with various internal governance committees to agree upon project prioritization and resulting timelines to assure that the technical teams are resourced to meet their objectives.
The Product Steward / TPT Lead role is highly cross functional and challenging, involving leadership across all sites of viral vector manufacture for the designated product.The Product Steward / TPT Lead develops strategy for the product franchise by representing viral vector on product strategy teams, and leading a cross-functional team that manages the viral vector technical project portfolio. The Product Steward / TPT Lead interacts regularly with site and corporate leadership in assessing resources required, communicating progress and risks, and presenting timelines and strategies for endorsement.The Product Steward / TPT Lead represents the viral vector manufacturing process in regulatory interactions such as inspections and other meetings.
The Product Steward / TPT Lead is the primary owner of the viral vector process, and leads or participates in large-scale process validation, regulatory filings, regulatory inspections and responses, technology transfers, troubleshooting, change management, process monitoring and robustness, continuous improvement, and other initiatives.The Product Steward / TPT Lead works with viral vector manufacturing site teams to troubleshoot manufacturing issues and develop process improvements using scale-down models of vector manufacturing.The Product Steward / TPT Lead collaborates closely with others in analytical, quality, regulatory, operations, development, supply chain, program strategy, global validation, third-party manufacturing, and manufacturing sciences roles to drive the franchise strategy.The position requires resolution of complex problems through strong leadership of cross-functional teams to meet quality, schedule, and cost objectives. This position is an Associate Director / Director level position that reports to the Senior Director of Vector and Gene Deliver MS&T.
- Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related experience in biologics upstream manufacturing:
- Minimum of at least a
- B.Sc/B.Eng with 14+ years or
- M.Sc/M.Eng degree with 12+ years or
- Ph.D. degree with 10+ of experience
- The primary owner of the viral vector process for the designated product.
- Develop product technical strategies including manufacturing requirements, process improvement plans, post approval life cycle management plans and ensure successful and timely execution working across functional groups.
- Provides technical leadership on strategic initiatives including tech transfers, process validation, technical reports, data analysis, process monitoring, change control, product comparability and escalated support of technical/scientific process and analytical issues.
- Defines strategy for the product franchise by representing viral vector on product strategy teams and leads a cross-functional technical team that creates and governs the viral vector technical project portfolio for the designated product
- Provide technical content for significant documents such as PPQ or comparability assessments, author content for regulatory submissions, present technical strategies during major health authority interactions and inspections.
- Collaborates closely with others in analytical, quality, regulatory, operations, development, supply chain, strategy, third party manufacturing and manufacturing sciences roles to drive the brand strategy.
- Lead efforts focusing on alignment and harmonization of manufacturing process across multiple sites.
Qualifications & Experience
- The candidate must have demonstrated verbal, written, and communication skills including ability to present complex information clearly and concisely, with a successful proven history of working with technical teams.
- Experience should include technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for viral vector manufacturing and processing equipment, manufacturing support and technology transfer.
- Strong knowledge of viral vector upstream (cell culture, transfection) and downstream (clarification, chromatography, tangential flow filtration) unit operations
- Demonstrated leadership skills, and the ability to interact with and lead diverse groups and teams are essential.
- 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.
- Prior experience in leading cGMP investigations utilizing formal Root Cause Analysis tools strongly preferred.
- Prior experience with SOPs, cGMPs and the know how to work within a regulatory environment required.
- Prior experience facilitating/participating in Risk Assessments preferred
If you want to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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