Senior Scientist, Gene Delivery and Editing Process Development , Cell Therapy Development
Core
Lead formulation and drug product development for lentiviral vectors (LVV), adeno-associated viral vectors (AAV), mRNA, and lipid nanoparticle (LNP) systems, focusing on biophysical and colloidal stability across liquid, frozen, and lyophilized presentations.
Role type
Senior Scientist, formulation and drug product development
Builds
Stable formulations for gene delivery and engineered cell therapy products
Domain
Biopharmaceuticals / Gene and Cell Therapy
Required skills
biophysical and colloidal stability expertise, freeze/thaw and cryopreservation study design, DSC/mDSC and DLS proficiency, excipient and buffer system design from first principles, lyophilization cycle development, regulatory documentation (cGMP/ICH)
Preferred skills
thermostabilization experience, particle and subvisible characterization (NTA, MFI), sterile drug product operations exposure
Technologies
DSC, mDSC, freeze-drying microscopy, DLS, NTA, MFI
Responsibilities
Design and execute stability-enabling formulation studies for viral vectors and nucleic acid products; characterize freeze-concentration, ice nucleation, and glass-transition behavior; develop excipient, buffer, and cryoprotectant systems; interpret development lab stability studies to support shelf-life claims; support technology transfer and process scale-up; author technical and regulatory reports.
Seniority
Senior, hands-on IC