MSAT Scientist II, Upstream
Core
Lead upstream cGMP manufacturing and technology transfer for viral vectors and gene therapies, ensuring robust, scalable production processes.
Role type
Senior IC manufacturing sciences scientist (upstream biopharma)
Builds
Late-stage clinical and commercial viral vector products
Domain
Biopharmaceuticals / Cell and Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
upstream biopharmaceutical manufacturing, process development, adherent mammalian cell culture (HEK), GMP compliance, process validation, technology transfer, risk assessment, CAPA implementation, process control strategy, PPQ execution, equipment qualification
Preferred skills
cell and gene therapy vector production, late stage/commercial technology transfer, single-use bioreactor technology (Cellstacks, Hyperstacks, iCellis), project management
Technologies
Stirred Tank Bioreactors, single use Bioreactors, Cellstacks, Hyperstacks, iCellis
Responsibilities
Lead technology transfer for upstream cGMP manufacturing; collaborate on process transfer and scale-up; author process definition, risk assessment, and PPQ protocols; monitor process performance and investigate deviations; support engineering in equipment selection and qualification; develop testing strategies with QC/QA.
Seniority
Mid-Senior, hands-on IC
