Director, Technical Operations Technology Transfer

Bristol-Myers Squibb • Seattle, WA

106d • $212,670 - $257,706 • Hybrid

About The Position

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.

Requirements

• B.S/MS/PhD in Engineering or Biology, Chemistry, Biochemical (Life Science) with 15+ years of relevant experience in the biopharmaceutical company.
• Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs.
• Knowledge of GMP manufacturing practices and documentation requirements.
• Excellent communication skills and ability to strategically influence the direction of the company.
• Strong knowledge and engineering leadership for Drug Product manufacturing and processing equipment.
• 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.
• Experience in product/process CMC life cycle management including pre-approval, launch and post-approval stages.
• Established track record of successfully developing and/or transferring drug products within a biopharmaceutical environment.
• Detail oriented with excellent verbal and written communication skills.
• Strong interpersonal and leadership skills to work with teams in different functions and organizations.
• Ability to assess risk and develop contingency plans for process risks.
• Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities.
• Strategic thinker with excellent problem solving and conflict resolution skills.
• Experience managing a technical team is required.
• Ability to foster a strong team-first environment with the ability to lead multiple projects.

Responsibilities

• 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.
• Create master plans including manufacturing requirements, and process improvement plans as part of the technology transfer.
• Define 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.
• 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.
• 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.
• Manage and mentor team members, providing guidance on deviations, change control, regulatory and project support.
• Present complex technical topics internally and externally.

Benefits

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs including paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree