Senior Scientist, Engineering
Core
Develop safe and robust manufacturing processes for small molecule and vaccine pipelines through process characterization, technology transfer, and validation of microbial fermentation and downstream processing.
Role type
Senior Scientist, Engineering (Bioprocess)
Builds
Manufacturing processes for small molecule and vaccine drug substances
Domain
Biopharmaceuticals / Chemical Engineering
Required skills
Microbial fermentation, Downstream processing, Process scale-up, Technology transfer, Quality Risk Management, Statistical design of experiments, cGMP compliance, Process validation, Regulatory filings, Mentoring
Preferred skills
Unit operations (crystallization, work-up), Quality by Design (QbD), Mathematical modeling, Regulatory file authoring
Technologies
Bioreactors, Chromatographic techniques, DOE tools
Responsibilities
Develop and validate manufacturing processes for late-stage projects; Optimize enzyme manufacturing process control strategies across scales; Mentor junior staff and enhance lab capabilities; Support technology transfer to commercial manufacturing; Conduct hands-on experimentation at lab and kilo lab scales; Ensure safety and quality compliance via cGMPs and GDPs.
