Director, Technical Operations Technology Transfer

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. 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.

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. Read more: careers.bms.com/working-with-us.

Position Summary

The Director, DP Tech Transfer owns the technology transfer of the late-stage (pivotal) and or commercial assets including ownership of the tech transfer plan, final report, key technical transfer documentation, and changes. This leadership role will provide technical, process leadership and ownership of the cell therapy manufacturing process transfer for clinical and commercial products.

• Provide leadership on strategic initiatives including tech transfers, process validation, technical reports, data analysis, process monitoring, change control, and product comparability.
• Drive cross collaboration and technical expertise with Development groups and commercial site on transfer of the late-stage (pivotal) DP process for clinical pipeline assets ensuring commercial readiness.
• Provide technical and process leadership for the cell therapy technology transfer of late-stage (pivotal) and commercial products including establishing requirements for the commercial and pivotal manufacturing processes, leading technical transfers to manufacturing and between sites
• Develop process qualification, process control, and comparability strategies, supporting the authoring of technical sections of major regulatory documents, and contributing to the overall CMC and commercial strategy
• Effectively collaborate with internal manufacturing sites, external CDMOs, and other BMS functions such as process and analytical development, quality, regulatory, and supply chain. Additionally, the role may include supervisory responsibilities for a junior technical team.

Key Responsibilities

• Strategic Planning and Technical Ownership: Own the technology transfer of commercial or late-stage (pivotal) assets including ownership of the tech transfer plan, final report, key technical transfer documentation, and changes.
• Develop and execute strategic initiatives including tech transfer, process validation, technical reports, data analysis, process monitoring, change control, and product comparability. This includes creating master plans including manufacturing requirements, and process improvement plans as part of the technology transfer and help define the post-approval life cycle management plans to ensure successful and timely execution working across functional groups.
• Provide technical input and requirements for the design of future clinical and commercial manufacturing facilities. Own key strategic initiatives such as developing best practices, tech transfer processes, playbooks, and dashboards.
• Cross-Functional Collaboration: Collaborate with Manufacturing, Process Development, Analytical R&D, Quality Operations, and MSAT to ensure comprehensive Tech Transfer oversight. Participate in relevant internal and joint governance meetings.
• Regulatory & Documentation: Author and review sections of regulatory dossiers, briefing books, and communications to health authorities concerning Tech Transfer approach. Prepare responses for information requests from regulatory bodies.
• Team Leadership: Manage and mentor team members, providing guidance on deviations, change control, regulatory and project support. Present complex technical topics internally and externally. 

Qualifications & Experience

• B.S/MS/PhD in Engineering or Biology, Chemistry, Biochemical (Life Science) with 15+ years of relevant experience in the biopharmaceutical company with most of that experience demonstrating progression of technical leadership responsibilities and scope. 
• Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs. Knowledge of GMP manufacturing practices and documentation requirements. Should have excellent communication skills an