Aseptic Control Principal Scientist, MSAT
Core
Principal Scientist leading aseptic control strategies for sterile and low bioburden processing of cell and gene therapy, small molecule, and combination medical device programs.
Role type
Principal Scientist, Aseptic Control
Builds
Sterile drug products and drug substances for commercialization
Domain
Biopharmaceuticals / Cell and Gene Therapy / Aseptic Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Aseptic processing technologies, Microbial control strategies, Risk assessment, Root cause analysis, cGMP compliance, Facility monitoring programs, Filter integrity testing, Contamination event resolution, Regulatory submission support, Process design for aseptic filling
Preferred skills
Experience with multiple modalities (sterile dosage forms, devices), Industry consortia participation, Strategic thinking
Technologies
GMP facilities, Aseptic filling equipment, Environmental monitoring systems
Responsibilities
Define strategies for microbial control of gowning and facility monitoring, Support manufacturing investigations involving aseptic processing, Design risk-based approaches to control bioburden, Support regulatory submissions and pre-approval inspections, Design new technologies for aseptic filling in novel device platforms, Establish post-approval performance monitoring capabilities
Seniority
Principal, technical leadership
