Senior Scientist, Gene Delivery and Editing Process Development , Cell Therapy Development

Bristol-Myers Squibb Co

Seattle (WA)

On-site

USD 124,000 - 150,000

Full time

5 days ago
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Benefits offered by this job

Wellbeing and disability protection
Flexible Time Off (FTO)
11 paid holidays
Stock options

Job summary

Bristol-Myers Squibb Co in Seattle seeks a Senior Scientist to lead formulation and drug product development for LVV, AAV, mRNA, and LNP systems, emphasizing stability across liquid, frozen, and lyophilized forms. You will design robust excipient systems, perform stability studies, and collaborate with process development and manufacturing teams.

Responsibilities include DTAs on cryopreservation, lyophilization, and regulatory documentation, with cross-functional communication to internal and

Qualifications

  • Demonstrated biophysical and colloidal stability expertise for biologic/advanced-modality products.
  • Experience with freeze/thaw and frozen-state stability and cryopreservation.
  • Proficiency with core techniques (DSC/mDSC, DLS, freeze-drying microscopy).
  • Ability to design buffer, cryoprotectant, and surfactant systems from first principles.
  • Experience with regulatory documentation and cGMP guidelines.
  • Strong scientific writing and data communication skills.

Responsibilities

  • Design and execute formulation and drug product development studies for LVV, AAV, and mRNA/LNP products across liquid, frozen, and lyophilized formats.
  • Lead freeze/thaw, cryopreservation, and lyophilization cycle development; study stability-related parameters.
  • Develop and justify excipient and buffer systems from first principles.
  • Maintain electronic lab notebook and communicate progress to teams.
  • Support tech transfer, process scale-up, and sterile fill/finish activities.
  • Build relationships with CMOs/CROs for external collaboration.
  • Draft technical reports and contribute to regulatory filings.
  • Maintain a safe work environment.

Skills

Biophysical stability
Cryopreservation
Lyophilization
DSC/mDSC
DLS
Data analysis & communication

Education

Ph.D. in Pharmaceutical Sciences/related field
M.S./B.S. in related discipline with substantial experience

Tools

DSC/mDSC
Freeze-drying microscopy
DLS
NTA/MFI

Job description

Position Summary

The Senior Scientist will lead formulation and drug product development for critical reagents and drug product — including lentiviral vectors (LVV), adeno-associated viral vectors (AAV), mRNA, and lipid nanoparticle (LNP) systems—used in gene delivery, gene editing, and engineered cell therapy programs. The role focuses on the biophysical and colloidal stability of these products across liquid, frozen, and lyophilized presentations, with particular emphasis on freeze/thaw behavior, cryopreservation, lyophilization, and thermostabilization strategies that reduce cold-chain burden. The incumbent will design and execute stability-enabling formulation studies, develop robust excipient and buffer systems, and support the transition of formulations from early development through clinical and commercial manufacturing, working closely with process development, analytical, and manufacturing partners and communicating data and timelines to internal and external stakeholders.

Duties/Responsibilities

Design and execute formulation and drug product development studies for viral vector (LVV, AAV) and nucleic acid/LNP (mRNA) products across liquid, frozen, and lyophilized presentations. Lead freeze/thaw and cryopreservation studies and lyophilization cycle development; characterize freeze-concentration, ice nucleation, glass-transition (Tg′) and collapse behavior, and their impact on titer, potency, particle size/PDI, and aggregation. Apply biophysical and colloidal characterization to elucidate degradation and instability mechanisms and to guide formulation decisions (e.g., DSC/mDSC, freeze-drying microscopy, DLS). Develop and justify excipient, buffer, cryoprotectant, and surfactant systems from first principles rather than by platform default. Design and interpret development lab stability studies to support phase-appropriate shelf-life and storage claims. Maintain accurate experimental documentation using an electronic laboratory notebook; summarize and present scientific data and communicate progress to project teams. Support technology transfer, process scale-up, and sterile drug product and fill/finish activities, partnering with internal subject-matter experts to build and apply GMP process knowledge. Develop and maintain relationships with external collaborators and service providers (CMOs, CROs) required to produce advanced-modality materials. Author technical reports and contribute to regulatory documentation, staying abreast of evolving global regulations and industry practices for cell and gene therapy products. Maintain a safe work environment in accordance with policies, procedures, and regulations.

Qualifications

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by management. Specific Knowledge, Skills, Abilities: Required – core biophysical and stability expertise: Demonstrated expertise in the biophysical and colloidal stability of biologic or advanced-modality products, including the mechanisms of aggregation, phase behavior, surface adsorption, and excipient-driven stabilization. Hands-on experience with freeze/thaw and frozen-state stability, including the ability to distinguish and address bulk drug-product freeze/thaw versus cell/vector cryopreservation. Working proficiency with core biophysical techniques such as DSC/mDSC and/or freeze-drying microscopy (Tg′, collapse temperature) and dynamic light scattering (DLS), with sound judgment on which technique answers which stability question. Ability to design and justify buffer, cryoprotectant, and surfactant systems from scientific first principles. Preferred/Development Supported: Hands-on lyophilization cycle development (collapse temperature, primary/secondary drying, cake structure, residual moisture, reconstitution), as opposed to general familiarity with lyophilization. Thermostabilization or cold-chain-reduction experience (e.g., moving a product toward lyophilized, refrigerated, or ambient-stable storage). Particle and subvisible characterization (e.g., NTA, MFI, particle size/PDI, encapsulation efficiency); further depth can be developed in-role. Exposure to sterile drug product operations and fill/finish (filtration, aseptic processing, container/closure), or clear readiness to develop this expertise with training and subject-matter-expert support. General technical and professional: Familiar with statistical approaches for study design (e.g., DOE, ANOVA, TOST) and able to communicate data analysis conclusions rigorously to internal and external audiences. Experience with regulatory documentation, submissions, and cGMP/ICH guidelines. Ability to communicate clearly and concisely through oral presentation and technical writing, including development reports and regulatory filings. General: General lab work including lifting up to 25 pounds.

Education/Experience/Licenses/Certifications: Ph.D. in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical/Biomedical Engineering, or equivalent; or M.S./B.S. in a related discipline. Ph.D. with 3+ years, M.S. with 6+ years, or B.S. with 10+ years of relevant formulation / drug product development experience. We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview: Seattle - WA: $124,190 - $150,483 The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits: Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability). U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year. Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays. Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year\'s Day. U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities 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.

Candidate Rights BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: 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/

Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.comwith the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account. R1606367 : Senior Scientist, Gene Delivery and Editing Process Development , Cell Therapy Development Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

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