Senior Director, CTTO Tech Transfer

Posted:
8/13/2024, 5:00:00 PM

Location(s):
Summit, New Jersey, United States ⋅ Massachusetts, United States ⋅ Washington, United States ⋅ Devens, Massachusetts, United States ⋅ New Jersey, United States ⋅ Seattle, Washington, United States

Experience Level(s):
Senior

Field(s):
Operations & Logistics

Workplace Type:
Hybrid

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 rich in diversity. 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.

Title: Senior Director, Cell Therapy Technical Operations Tech Transfer

Location: Seattle, WA, Devens, MA or Summit, NJ

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Senior Director, Cell Therapy Technical Operations Tech Transfer provides technical and process leadership and ownership of the cell therapy manufacturing process for commercial products. This is a key technical role within BMS’s cell therapy technical operations division as we expand the growth of our approved commercialized autologous cellular biologics products to overcome tumor evasion and potentially eradicate cancer cells. This role will assume primary technical leadership for the manufacturing process of drug product for one or more CAR T programs. This includes establishing the requirements for the commercial manufacturing process, coordinating technical transfers to manufacturing and between sites, developing 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.

The scope of the role includes providing ongoing technical oversight to manufacturing, defining and driving a long-term process improvement lifecycle plan and ensuring successful execution of the technical strategy. The role will work cross-functionally across technical operations and most closely with external IDMOs, and other functions within BMS such as process and analytical development, quality, regulatory, manufacturing and supply chain counterparts in coordinating the technology transfer of commercial programs. The role may assume supervisory responsibility for a junior technical team. This role will be a member of the Cell therapy CMC team. The incumbent will help drive the technology transfer, validation, qualification and comparability strategies and be viewed as a technical thought leader internally and externally in cell therapy drug product manufacturing technology.

Key Responsibilities:

  • Own the technology transfer of the commercial assets including ownership of the tech transfer plan and final report
  • Develop product technical strategies including manufacturing requirements, process improvement plans as part of the technology transfer and also help define the post approval life cycle management plans and ensure successful and timely execution working across functional groups.
  • Provide technical leadership on strategic initiatives including tech transfers, process validation, technical reports, data analysis, process monitoring, change control, and product comparability.
  • Collaborate with Technical Development groups on lifecycle improvements for the commercial products.
  • Provide technical content for significant documents such as tech transfer plan/report, PPQ or comparability assessments, author content for regulatory submissions, present technical strategies during major health authority interactions and inspections.
  • Perform and support data monitoring of manufacturing processes to understand successful tech transfer, process capability and to increase robustness and sustainability.
  • Function as a subject matter expert for autologous T cell therapies and manufacturing technologies.
  • Provide technical input and requirements for design of future clinical and commercial manufacturing facilities.
  • Serve as a mentor to staff in the technical teams.
  • Present complex technical topics internally and externally.

Qualifications & Experience:

  • B.S., M.S. or Ph.D in Engineering or life science with >16 years of relevant technical experience in technical development, manufacturing science or other disciplines in technical operations.
  • Strong understanding of bioprocess unit operations, especially cell culture.
  • Excellent written and verbal communication skills. Ability to convey complex technical issues to diverse audiences including internal teams, external partners, and health authorities.
  • Demonstrated experience developing and/or transferring drug products within a pharmaceutical environment.
  • Proficient in project management and team leadership skills, with a thorough understanding of critical unit operations involved in drug product manufacturing.
  • Experience in technical supervision, coaching and mentoring or leading small matrixed teams of people or scientific projects.
  • Evidence of strong communication skills and of building good relationships with cross functional team members and customers.
  • Established scientific professional with track record of technical and cultural leadership and globally-recognized accomplishments that include advancing projects. Influences site and global strategy. Visible contributions to external scientific community, including regulatory settings.
  • Experience in product/process CMC life cycle management including pre-approval, launch and post-approval stages.
  • Strong analytical, problem-solving, and critical thinking skills.
  • Sound experience of data handling and applied statistics.
  • Experience with Quality Management System (e.g. Deviations, CAPAs, Change Management)
  • Previous experience in managing technical interactions with CMOs, manufacturing of cell therapies, or product life cycle management is highly desirable
  • Previous experience in managing direct technical staff is preferred.

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.

The starting compensation for this job is a range from $206,000 - $258,000 (if based in Summit, NJ), $214,000 - $268,000 (if based in Devens, MA) and $220,000 - $275,000 (if based in Seattle, WA), plus incentive cash and stock opportunities (based on eligibility). 


The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.


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 our BMS 
Career Site. 


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. 

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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.

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 an inclusive culture, promoting diversity 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 a diverse 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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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