Senior Associate Scientist, Gene Delivery & Editing Process Development

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: Senior Associate Scientist, Gene Delivery & Editing Process Development

Location: Seattle, WA

Cell Therapy is one of the most groundbreaking new forms of cancer treatment 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.

We are seeking an enthusiastic, self-driven Senior Associate Scientist to join the Gene Delivery & Editing Process Development team. Our team develops the end-to-end processes and technologies to deliver the critical raw materials used in the manufacturing of engineered T cells, including viral vectors. This team member will play a key role in the tech transfer and support of clinical manufacturing (up to process performance qualification (PPQ)) of gene-delivery raw materials such as: DNA, RNA, Enzymes, RNPs, viral vectors, and cell lines. The ideal candidate will have experience with process development and/or early-stage clinical manufacturing including proficiency in supporting tech transfers, deviations, change controls, and OOS investigations. Hands on experience operating production processes in a manufacturing environment is desirable.

Key Responsibilities:

• Support process and technology transfers, change management, and technical process support for successful clinical stage manufacturing of gene-delivery raw materials such as: DNA, RNA, Enzymes, RNPs, viral vectors and cell lines.
• Monitor internal and external clinical manufacturing up to process performance qualification (PPQ), identifying and managing implementation of process improvements and change controls, managing process deviations and out of specification investigations through approved quality systems for manufacturing of gene‑delivery raw materials
• Visit internal and external manufacturing sites as needed to support OOS investigations, tech transfer activities, and regulatory inspections
• Support the development and implementation of early-stage tech transfer plan to streamline transition from PD to clinical manufacturing teams
• Identify technical gaps in the form of risk assessments and work with PD colleagues to de-risk tech transfer, scale up/scale down and improve clinical vector processes throughout the clinical development period
• Provide technical documentation supporting manufacturing and process development sections of regulatory filings
• Up to 25% travel

Qualifications & Experience:

• M.S. with 2+ years of experience or B.S. with 3+ years of experience in process development or commercial manufacturing  
• Experience in a biotechnology process development or manufacturing environment for globally regulated products, such as cell & gene therapies, vaccines, or biologics
• Experience with PD and/or early-stage clinical manufacturing with experience in managing process development, tech transfers, Deviations and OOS investigations.
• Experience writing and reviewing GMP documentation
• Experience using statistical software (ex. JMP) for analysis of process and manufacturing data
• Experience with cGMP and ICH guidelines
• Proven ability to work in a fast-paced, multi-product, matrixed environment spanning groups at different geographical locations
• Ability to communicate clearly and concisely through oral presentation and technical writing, including development reports and regulatory filings
• Demonstrated ability to effectively work in cross-functional teams, meet deadlines, and prioritize multiple projects
• Desire a