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 used in gene delivery and cell therapy, 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 viral vectors and nucleic acid/LNP products
Domain
Biopharmaceuticals / Gene Therapy / Cell Therapy
Required skills
Biophysical and colloidal stability expertise, Freeze/thaw and cryopreservation study design, DSC/mDSC and freeze-drying microscopy proficiency, Dynamic light scattering (DLS) analysis, Excipient and buffer system design from first principles, Regulatory documentation and cGMP/ICH guidelines knowledge
Preferred skills
Lyophilization cycle development, Thermostabilization or cold-chain reduction experience, Particle and subvisible characterization (NTA, MFI), Sterile drug product operations and fill/finish exposure
Technologies
DSC, mDSC, Freeze-drying microscopy, DLS, NTA, MFI
Responsibilities
Design and execute formulation studies for viral vector and nucleic acid/LNP products, Lead freeze/thaw and cryopreservation studies and lyophilization cycle development, Apply biophysical characterization to elucidate degradation mechanisms, Develop and justify excipient and buffer systems, Design and interpret development lab stability studies, Support technology transfer and process scale-up
Seniority
Senior, hands-on IC