Partner with manufacturing teams to define clear objectives, select fit-for-purpose statistical tools, and design/analyze experiments for process optimization and validation
Job Summary
Partner with manufacturing teams to define clear objectives, select fit-for-purpose statistical tools, and design/analyze experiments for process optimization and validation.
Analyze stability and shelf-life studies, establish ongoing monitoring using SPC and CPV, and troubleshoot OOS/OOT results.
Develop reproducible, auditable analyses and prepare clear statistical content for CMC documentation, assisting with regulatory queries.
Matching Summary
Partner with manufacturing teams to define clear objectives, select fit-for-purpose statistical tools, and design/analyze experiments for process optimization and validation.
Salary
Base: $126,500.00 - $199,100.00; Bonus/Equity: Annual bonus and long-term incentive, if applicable; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation, sick days
Skills & Requirements
Must-have
Design of Experiments (DoE)
Statistical Process Control (SPC)
ICH guidance
Bayesian statistical framework
SAS, R, JMP, Minitab
Nice-to-have
Critical thinking and domain knowledge
Scientific partnership
Risk and sensitivity analysis
Original and creative thinking
Key Requirements
10 years BS or 5 years MS in statistics or related field
Industrial statistics coursework/experience
Pharmaceutical vaccine manufacturing experience
CMC activities experience
Proficient in live virus potency and recombinant protein analytics