Gene Editing Materials Analytical Program Lead

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: Gene Editing Materials Analytical Program Lead

Location: Seattle, WA or Warren,

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 Gene Editing Materials Analytical Program Lead drives the analytical technical strategy and execution of cell therapy gene-editing materials, including CRISPR-Cas (RNP) technology and non-viral gene delivery materials, to deliver CMC program milestones. The ideal candidate has a proven track record of scientific and technical proficiency, experience with analytical CMC matrix team leadership, product analytical strategy, analytical method transfer, understanding of technical capabilities of contract manufacturing organizations, contract test laboratories, and demonstrated skillset/knowledge of analytical development. This position will serve as Cell Therapy Analytical Development (CTAD) department single point of contact for technical aspects of a gene-editing material program’s analytical strategy in a matrix team supporting product release, characterization and in-process testing of the gene-editing materials for cellular drug product manufacturing.

Key Responsibilities:

• Develop actionable strategies and plans that ensure alignment with short-term and long-term program objectives developed in tandem with CTAD leadership.
• Work with external partners (CDMO, CTL, business partners), and BMS internal functions (CTAD, research, process development) to develop process and product deep understanding, and derive the analytical strategy matching with the gene-editing CMC programs needs at different development phases.
• Direct analytical strategy implementation, resources and overall project execution
• Partner with CTAD, Process Development, Quality, Manufacturing leaders to foster cross-functional collaboration and appropriate alignment
• Contribute to analytical risk identification, assessment and mitigation
• Ensure strategy/status/summary data/issues/plans for functional areas are presented at relevant meetings and governance board
• Accountable for gene-editing materials release specifications and justification of specifications
• Serve as author/reviewer for analytical sections of CMC submissions and responses to regulatory questions
• Lead analytical method transfer from Analytical Development to QC or between different QC laboratories, and collaborate with quality organization to prepare for commercial method readiness

Qualifications & Experience:

• Ph.D. or Master degree in analytical sciences or related fields with minimum 5 (for Ph. D.) or 7 (for Master and other relevant degrees) years of experience in the development and approval of cell & gene therapy products or biologics or other relevant fields.
• Strong scientific knowledge in gene editing technologies and associated key components commonly used for cell therapy manufacturing including CRISPR-Cas system and non-viral gene-delivery materials
• Extensive experiences with CMC analytical strategy and demonstrated technical proficiency.
• Experiences with successful analytical method transfer especially in complex scenarios with multiple labs involved
• Good communication skills and be able to work cross-functionally with QC, QA, analytic