Drug Product Development Scientist - Viral Vector
Core
Design, execute, and optimize scalable Lentiviral Vector (LVV) drug product formulation and fill & finish processes for clinical and commercial scales.
Role type
Drug Product Development Scientist (Viral Vector)
Builds
Lentiviral Vector drug products for ex vivo and in vivo applications
Domain
Biotechnology / Gene and Cell Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
UFDF, formulation development, particle characterization, automated drug product filling, container closure, stability studies, DOE design, cGMP compliance, CMC documentation
Preferred skills
Tech transfer to CDMOs, preclinical to commercial scale process design, regulatory filing experience
Technologies
UFDF, automated filling systems, stability testing equipment
Responsibilities
Develop new platform LVV formulations; design and support fill and finish activities at pilot and clinical scales; develop scale-down models for tech transfer; execute process characterization studies; implement next-generation formulation technologies; author protocols and CMC content for regulatory submissions
Seniority
Mid-level, hands-on IC