Engineer II, Drug Product Development
Core
Develop sterile drug product processes and products for clinical and commercial supply, focusing on scale-up, tech transfer, and stability studies for mRNA therapeutics.
Role type
Drug Product Development Engineer
Builds
Sterile drug product manufacturing processes, scale-down models, and container closure systems for mRNA therapeutics
Domain
Biopharmaceuticals / mRNA therapeutics / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical sciences, process development, scale-up, aseptic fill/finish operations, DoE, statistical analysis, characterization techniques (microscopy, particle sizing), ELN documentation
Preferred skills
BioPharma industry experience, GMP compliance knowledge, nucleic acid chemistry knowledge
Technologies
ELN, DoE tools, analytical instrumentation
Responsibilities
Conduct studies to support scale-up and tech transfer of drug product manufacturing; Develop protocols to evaluate compatibility of drug product with processing materials and sterilization processes; Plan, organize and execute experiments using DoE; Perform routine and non-routine characterization techniques; Support manufacturing with process trouble-shooting and investigations; Develop processes to ensure long-term stability of vialed drug product
Seniority
Junior to Mid-level, hands-on IC