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

Bristol Myers Squibb•Seattle, WA

9d•Onsite

About The Position

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.

Requirements

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.
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 lab work including lifting up to 25 pounds.
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.

Nice To Haves

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.

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.

Benefits

wellbeing support
retirement and financial protection benefits
insurance offerings (medical, dental, vision, life and disability)
Flexible Time Off (FTO)
11 paid company holidays
160 hours of paid vacation annually
3 optional holidays
paid sick leave
up to two paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
annual Global Shutdown between Christmas Day and New Year's Day