MSAT Scientist
Core
Conduct process investigation, optimization, and scale-up studies for cell and gene therapy manufacturing while ensuring data integrity and supporting tech transfer.
Role type
MSAT Scientist (Process Development)
Builds
Manufacturing processes for cell and gene therapy products
Domain
Biopharmaceuticals / Cell and Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process optimization, scale-up study, GMP compliance, QbD, statistical analysis, tech transfer, CAPA handling, validation study design
Preferred skills
BLA experience, cell and gene therapy industry experience, 211/985 university background, overseas work experience
Technologies
Chromatography resin, reusable filter members, mixing systems, cleaning systems
Responsibilities
Prepare TTP and conduct gap analysis for tech transfer, ensure integrity of tech data and documentation, conduct process investigation and scale-up studies, handle troubleshooting and deviations during manufacturing, participate in validation studies (resin, filter lifetime, mixing, cleaning, yield), attend GMP audits and regulatory filings
