Associate Principal Scientist, Sterile Drug Product Commercialization
Core
Lead lab operations and capability build for late-stage and commercial sterile drug products (vaccines, biologics) while supporting technology transfer and process scale-up.
Role type
Associate Principal Scientist (Lab Excellence Lead / Tech Transfer Lead)
Builds
Sterile drug products (vaccines, biologics, combination products) for commercial launch
Domain
Biopharmaceuticals / Bioprocessing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biologics process optimization, Technology transfer, Manufacturing scale-up, New Product Introduction (NPI), Regulatory requirements, Mentorship, Protein purifications, Vaccine development
Preferred skills
Sterile drug product fill-finish practices, Late-stage commercialization experience, cGMPs, Quality by Design, Lean-Six Sigma
Technologies
None explicitly listed as tools/frameworks
Responsibilities
Lead lab operations and drive safety/compliance culture; Support technology transfer as Sending Unit Lead for NPI; Drive process optimization for standardized platforms; Provide technical oversight and strategic guidance to team members; Ensure commercialization programs meet science, quality, and cost requirements; Develop and validate fit-for-purpose scale-down models.
Seniority
Senior, hands-on IC with strategic oversight
