Senior Director, Cell-Based Assay Analytical Development

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Title: Senior Director, Cell-Based Assay Analytical Development

Location: Seattle, WA

This critical senior position will be responsible for growing the capabilities required to provide technical stewardship for cell-based analytical method development that will be employed for clinical and commercial cell therapy pipeline programs. As the head of this group, the candidate will also cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to organizational opportunities and challenges.

This role will report to the Head of the Cell Therapy Analytical Development (CTAD) within Cell Therapy Development (CTD). The incumbent will be responsible for leading a diverse team focusing on providing technical stewardship for cell-based based analytical methods required to support release and characterization for cell therapy products. This role will partner closely with colleagues in Research, CTAD, and CTDO to ensure seamless transition of methods to enable clinical stage manufacturing that are then scaled and implemented for commercial supply. This position will be based in Seattle, WA.

Key Responsibilities:

• Lead a high performing team by developing and retaining talent, ensuring the development and implementation of training required to fully qualify staff for establishing and maintaining capable and controlled processes. Lead and develop a strong winning culture, fostering teamwork and commitment to excellence through transparent communication and staff engagement.
• Partner with colleagues in Research to transfer in relevant biological understanding and analytical methods as appropriate as programs transition into the clinical phase of development.
• Lead the strategy for cell-based potency assay development, innovation, and implementation
• Partner closely with colleagues to develop, transfer and validate analytical methods in a clinical and commercial QC environment. This will initially involve working closely with peers in CTAD and the global quality organization to move methods through different phases of development and into commercialization, and ensure appropriate technical governance is established.
• Establish processes and capabilities to provide technical stewardship of cell-based methods to support broad cell therapy pipeline programs including establishing method performance monitoring capability and method troubleshooting/ out of conformance event resolution. This will involve partnering closely with internal testing functions, cell therapy process development teams, manufacturing and QC functions to establish processes to monitor test method performance and continuous improvement initiatives.
• Build analytical technical expertise and capabilities required to drive life-cycle management technical agendas to support analytical characterization and comparability capabilities
• Champion the culture of quality and ensure that all activities and documentation comply with regulatory requirements. Understand and implement processes, controls, and methods that align with Global Health Authority regulatory expectations. Drive operational excellence, flawless execution and continuous improvement.
• Representative of CTAD to define product specifications and justifications to support various regulatory submissions including IND and BLA.

Qualifications & Experience:

• Master’s or Ph.D. in biology, immunology, or related field
• >15 years progressive experience in a key leadership role in cell-based analytical development, with hands-on experience on assay development and product control strategy development, preferably in cell therapy
• Leadership experience to manage assay development function and capability to build and grow a technical function.
• Deep understanding of analytical method development and quality control that support manufacturing activities; direct experience in method development used for cell and gene therapies along with viral delivery and/or non-viral delivery is advantageous. Key technical expertise on cell-based assay development.
• A proven ability to work seamlessly across teams and develop excellent relationships and partnerships with peers.
• Provide motivational leadership of a cohesive high-performing team within a global, highly matrixed environment with the ability to articulate vision and successfully drive execution
• Demonstrated understanding of the principles and applications associated with product release, characterization and process control methods for biological, cellular, and genetic therapies.
• Expert level knowledge of regulatory requirements for biological and cell therapy product development through preIND to BLA
• Strong knowledge of cGMP and GSP requirements
• A strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
• Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprise-wide
• Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them
• Resilient and able to work well in a demanding, fast paced environment
• Keeps current on professional knowledge, expertise and best practice
• Demonstrated experience establishing and managing technology development and technical governance structures.

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 $220,000 – $275,000 , 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 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 adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

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