Executive Director, Cell Therapy Analytical Development F NEW

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 .

SUMMARY:

We are searching for a highly collaborative, people-focused leader who will be accountable for the global network of Cell Therapy Analytical Development. This individual will drive innovation and implement end to end practices for leading cell therapy drug product and viral vector analytical development and attribute sciences, integrating with the global CT Quality network strategy. This person will be accountable for holistic CT Analytical Development strategy and will drive enterprise collaboration with relevant areas in partnership with Process Development.

ROLES & RESPONSIBILITIES:

• Lead all Cell Therapy Drug Product analytical development activities and teams across multiple sites and across the different cell therapy approaches (autologous, edited, and allogeneic)
• Partner and collaborate with Cell Therapy Drug Product Process, Vector Process, Quality and CT Technical Operations to execute on overall CT DP strategy; partner with R&ED on patient attribute analyses.
• Develop and implement cost effective and cost competitive assays for all cell therapy DP approaches, including associated raw materials & product residuals
• Develop phase appropriate FIH assays to enable speed on portfolio delivery; execute GMP characterization testing in support of clinical studies
• Lead Product Sciences in support of clinical and commercial specification setting and complex commercial investigations
• Define and harmonize global strategies for developing, characterizing and enabling validation of CT DP assays, specifications, product science approaches to patient correlative analyses, raw material testing for both early and late-stage assets as applicable
• Evolve data lake and predictive data science in collaboration with IT and R&ED
• Develop and lead implementation of CT DP analytical strategy aligned with the Quality and Operations network, R&ED strategy and commercial considerations for CT
• Oversee GMP testing associated with FIH DP manufacturing and support extended characterization analyses for the end-to-end portfolio (including LCM)
• Provide technical oversight of DP assay related investigations at internal and external manufacturing sites as required.
• Partner with Quality and Cell Therapy Technical Operations on novel technologies, analytical approaches and associated IP helping to protect and create value for the BMS portfolio of CT & gene therapy assets
• Build high performing teams that excel at working in matrices across BMS. Attract, hire, manage and develop world class scientific, technical and engineering talent and create and environment where they can thrive.
• Create strong partnerships to continually evaluate and evolve the department’s strategic plan to ensure alignment with business objectives while balancing cost, time and speed.
• Drive engagement with the broader external CT community and influence direction of the field
• Serve as a member of the Cell Therapy Development leadership team, participating in portfolio review and project governance meetings and providing guidance for best practices and direction for continuous improvement.
• Contribute to, review and approve regulatory CMC submissions to ensure their quality and technical content
• Reports to Vice President of Cell Therapy Development

REQUIREMENTS:

• PhD preferred in Immunology, biochemistry, life sciences, pharmaceutical sciences, biochemical engineering, or other related field
• Minimum of 15 years of relevant experience
• Experience leading teams of people across multiple geographic locations (~25 % travel required)
• Demonstrated experience in developing and establishing analytical strategies required for early, late, and commercial stage cell therapy and viral vector processes & assays
• Experience with integration of control strategies with understanding of attribute sciences & method development/validation and specification setting
• Broad understanding of T-cell biology and product attribute sciences
• Experience with multiple analytical techniques used to characterize and quantify CT Drug Product, viral vector, and gene editing reagents
• Experience with analytical method development & validation of CT assays
• Ability to work across all CT approaches (autologous, allogeneic, gene-edited)
• Experience partnering with CMC teams to define and deliver tech strategy required for product licensure.
• Understanding of ICH guidelines
• Experience with partnering externally on product and technology development
• Understanding of enterprise network strategy and development execution impact on P&L

The starting compensation for this job is a range from $245,000 USD – $325,000 USD, 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

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 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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