Director, Sterility Assurance, Cell Therapy Technical Operations

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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.

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Title: Director Sterility Assurance, Cell Therapy Technical Operations

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

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 Director of Sterility Assurance, Cell therapy technical Operations reports to the Executive Director, Drug Product Cell Therapy Technical Operations within the Cell Therapy Development and Operations (CTDO) organization. This Technical Leadership role will provide technical oversight to drug product and vector sites as the global SME covering all aspects of sterility assurance for commercial cell therapy products manufactured globally via internal and external manufacturing sites.

This role will serve as the Global SME and will develop global technical standards for cell therapy sterility assurance and deploy the standards to site MS&T at internal and external sites. The Sterility assurance team will be accountable for developing sterility assurance standards, process qualification strategy and framework to support clinical and commercial manufacturing across the CT network. The Team is accountable for implementation of this guidance and strategies in a consistent manner across products and sites and ensuring that these standards are reflected in the quality system.

The Cell Therapy Lead will also cover life cycle management and implementation of new technologies and strategies with respect to sterility assurance providing SME guidance of support to CT manufacturing sites for routine manufacturing and major investigations. The roles will also provide guidance and support for all aspects of regulatory submission, inspections, IR responses process, equipment and supporting elements of manufacturing validation for all cell therapy products in the portfolio, internal and external manufacturing processes/facilities for viral vector and drug product. The person will own the accountability for the Sterility function by providing oversight of all the validation activities, including providing SME assessment for proposed process life-cycle changes. The lead will serve as the Global Point of Contact for sites and will work with the sights to provide sterility assurance guidance and oversight.

This person will also support sterility assurance activities needed during design and build of new manufacturing plants and new product introductions ensuring compliance with the global health authority expectations.

Key Responsibilities
Lead, develop and implement scientifically sound and fit for purpose validation standards and procedures based on current regulations, industry standards and industry best practices for cell therapy.

• Create, maintain, deploy global cell therapy sterility assurance technical standards via quality system.
• Promote innovative and efficient approaches to sterility assurance incorporating risk-based elements and considerations unique to cell therapy production.
• Serve as global consultant for sterility assurance investigations, regulatory inspections/submission/IR responses.
• Support CMC authoring for relevant sections related to sterility assurance.
• Develop and deploy global standards with respect to Aseptic process simulation (APS), sterile filtration, clean room classification.
• Promote harmonization and best practices for all aspects of contamination control including but not limited to gowning, EM, disinfection, facility flow.
• Develop and provide guidance for contamination response, Microbial hold studies, disinfectant efficacy
• Drive innovation in sterility assurance for cell therapy supporting the implementation of new technologies and contamination control strategies (filtration, VHP, etc.)
• Accountable for development and life cycle management of risk assessments, regulatory gap assessment
• Support Network, collaborate with site SME's for
  • Technical review for site-level protocol and reports
  • Technical review for CMO documentation
  • Microbial control strategies for new products
  • Oversight of major contamination investigations
  • Tech transfer (startup activities)
• Maintain and develop BMS expertise in sterility assurance via involvement in external industry groups (Ex. PDA)
• Act as Cell Therapy liaison to BMS Micro center of excellence
• Facilitate cell therapy harmonization for existing manufacturing sites and adoption of industry best practices.

Qualifications & Experience

• B.S/MS.S/Ph. D in Chemical Engineering or Life Science with 10+ years of relevant experience in the biopharmaceutical company with most of that experience demonstrating progression of leadership responsibilities and scope.
• Previous experience should be a combination of technical operation functions such as manufacturing, quality, MS&T or Technical Development. At least 8 years of direct experience in GMP environment is necessary.
• The leader should have the ability to define the right processes for the team's maturity level, balancing agility and discipline. Career track record and industry reputation should be competitive at the highest level among industry peers.
• Leader should have demonstrated skill to lead large, complex technical organizations with global scope and build people, processes, and technology in a growing organization. In particular, recruiting and developing strong technical talent in these diverse areas of scope mentioned above will be a key consideration.
• Strong leadership track record especially in the areas of leading in a global and matrix environment, working cross functionally and developing strong technical talent
• Leader should have excellent communication skills and be able to strategically influence the direction of the company in the scope areas mentioned above. This leader will exemplify strong leadership values and be an internal and external facing ambassador of the company in the stated areas of scope in this function.
• Experience leading regulatory inspections regarding validation and extensive knowledge of regulations, current industry practices, and experience with interpretation and application of guidelines and regulations.
• Experience with Quality Management System.
• 2-3 years of experience in cell therapy process development and or manufacturing, preferred.
• Combination of experience in process development, MSAT and quality, 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 $182,000 - $228,000 (if based in Summit, NJ), $189,000 - $236,000 (if based in Devens, MA) and $194,000 - $242,000 (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.

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