Associate Director Process Validation - Gene Deliver Commercial Network; Manufacturing Science and Technology

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.

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.

Position Summary

Come, join the BMS Cell Therapy Development & Operations (CTDO) Division, and be a part of the team building leading cell therapy platforms to serve our patients with novel cellular immunotherapies. The Viral Vector Commercial Network Manufacturing Science and Technology (MS&T) group plays a critical role in technology transfers, process validation, CMC life cycle management, technical oversight of external manufacturing partners, process engineering and establishing manufacturing standards to enable a robust and scalable global cell therapy manufacturing network.

We are looking for an Associate Director for our Viral Vector Commercial Network MS&T group. The successful candidate will lead efforts related to vector manufacturing technologies from process performance qualification to GMP manufacturing. The Associate Director will be responsible for overseeing the lifecycle management, process robustness initiatives, process monitoring, manufacturing technical support, including cross-departmental collaboration to enable facility fit of new technologies, development of process documentation (Batch Records, Forms, etc.), training of personnel, change control ownership, and other quality system related deliverables as well as development and support of PPQ strategies and commercial manufacturing. This person will collaborate across all CMC functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities. The Associate Director will play a key role in product lifecycle management, including strategic development, characterization, commercialization, and evolution of cell therapy products. This position reports to the Senior Director of the Viral Vector Commercial Network MS&T group.

Key Responsibilities

• Lead MS&T activities at the viral vector manufacturing site to establish uninterrupted commercial vector manufacturing and supply.
• Leads, Manages, and Coaches process engineers.
• Develop and implement validation policies to define robust process validation program within the cell therapy product lifecycle.
• Participate in generation and approval of PPQ enabling deliverables generated during late-stage process development and characterization.
• Author CMC content for regulatory filings and participate in formal agency meetings.
• Coordinate responses to health authority questions on process validation that require a coordinated response or implementation across cell therapy manufacturing.
• Establish the foundation for technical process leadership for routine commercial batches and on time closure of all quality system records such as deviations, CAPAs and change controls.
• Lead the development, understanding, and management of tools/templates to monitor vector manufacturing process performance and lead the understanding and improvement of process capability.
• Deliver the implementation and execution of process control strategies, including execution of process risk assessments and continued process verification (CPV) thereby ensuring the manufacturing process is in a state of control.
• Ensuring compliance with internal standards and regulatory requirements for process and production related investigations.
• Develop and maintain strong relationships with the manufacturing site and their vendors.
• Ensure permanent inspection readiness and actively support regulatory inspections.
• Lead and deliver on harmonization across the cell therapy manufacturing network.
• Share operational best practices and process learning with the rest of the manufacturing network.

Qualifications & Experience

• Biochemical, Chemical, Biomedical Engineering or Cell Biology/Immunology discipline with
  • B.S. with 14 years of relevant experience
  • M.S with 12 years of relevant experience
  • Ph.D. with 8 years of relevant experience
• Experience with cellular therapies is desired but not required.
• Prior management experience desired.
• 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.
• Flexibility to work within manufacturing schedules and ability to travel to manufacturing site.
• Ability to work in a self-driven, performance/results oriented, fast paced matrix environment. Excellent communication, writing, sense of urgency, teamwork, and presentation skills.
• 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.
• Strong interpersonal skills required to work with teams in different functions and organizations.
• Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.
• Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab) strongly suggested.
• Detail oriented with excellent verbal and written communication skills.

Travel 20-30% of the time is possible.

The starting compensation for this job (for Washington State) is a range from $149,000-$188,000 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 website https://careers.bms.com/working-with-us

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.

BMSCART

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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.