Director, Technical Operations Technology Transfer
Karuna Therapeutics
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 and be able to strategically influence the direction of the company in the scope areas mentioned above.
- Strong knowledge and engineering leadership for Drug Product manufacturing and processing equipment, manufacturing support and technology transfer. 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. This position will require up to 20% travel.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: 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 include 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. Other perks like tuition reimbursement and a recognition program.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
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