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

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.

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.

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…