Senior Scientist, Clinical Stage Process Development & Manufacturing Support, Gene Delivery & Editing Process Development Full-time NEW

Gene Delivery & Editing Process Development Team Member

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. 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.

We are seeking an enthusiastic, self-driven individual 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, change controls, and technical support for quality events. Hands on experience operating production processes in a manufacturing environment is desirable.

Key Responsibilities:

• Lead process and technology transfers, change management, and technical process support for successful clinical stage manufacturing of gene-delivery raw materials.
• Represents department on cross-functional CMC teams with a high degree of independence. Negotiates project timelines and deliverables. Accountable for communicating changes to department and project leadership. When needed act as overall CMC lead for GDE (gene delivery and gene editing) materials and/or lead cross-functional technical teams.
• Provides high level technical guidance for clinical manufacturing site selection and process decisions. Applies a risk-based approach to strategy decisions; identifies and can communicate risks to management. Conduct due diligence to assess onboarding of new gene-delivery vendors.
• Monitor internal and external clinical manufacturing up to process performance qualification (PPQ), identifying and managing implementation of process improvements and change controls, and provide technical support for quality events for manufacturing of gene-delivery raw materials.
• Visit internal and external manufacturing sites as needed to support tech transfer activities, ensure manufacturing success as person in plant, and assist regulatory inspections.
• Develop, implement, and optimize 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.
• Author manufacturing and process development sections of regulatory filings as well as technical documents suitable for presentation to regulatory authorities.
• Up to 25% travel.

Qualifications & Experience:

• PhD. with 2+ years of experience, M.S with 4+ years of experience, or B.S. with 7+ years of experience.
• Experience in a biotechnology process development or manufacturing environment for globally regulated products, such as cell & gene therapies, vaccines, or biologics.
• Demonstrated high level of technical expertise for one or more modalities supported by department.
• Experience supporting GMP oligonucleotide synthesis and/or GMP sterile fill/finish preferred.
• Experience with PD and/or early-stage clinical manufacturing with experience in managing process development and tech transfers and providing technical support for quality events.
• Experience writing and reviewing GMP documentation.
• Demonstrated ability to develop and apply sophisticated tools for analysis of process and manufacturing data.
• Experience authoring regulatory documents and submissions.
• 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.
• Demonstrated ability to effectively work in cross-functional teams, meet deadlines, and prioritize multiple projects.
• Ability to work across multiple modalities.
• Desire and drive to increase access of cell and gene therapy products and passion for their impact on the lives of patients with serious diseases.
• Open to working in the wet-lab to support generation of data for support of tech-transfer/facility fit, change controls, investigations.

Compensation Overview: Seattle-WA: $126,570 – $153,377. The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. 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 careers.bms.com/life-at-bms/. 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.

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 a supportive culture, promoting global participation 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 an 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.