Associate Principal Scientist, Engineering - Vaccine, Sterile Drug Product Commercialization
Core
Lead technical process leadership and laboratory capabilities for late-stage and commercial drug product processes for vaccines, biologics, and sterile pharmaceutical products.
Role type
Senior IC Associate Principal Scientist (Vaccine/Biologics Commercialization)
Builds
Commercial vaccine and biologics drug products via scale-up, technology transfer, and process validation
Domain
Biopharmaceuticals / Vaccine Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Drug product process development, Process characterization, Scale-up, Technology transfer, Process validation, Regulatory submissions (CMC), cGMP compliance, Sterile fill-finish operations, Platform engineering, Quality by Design (QbD)
Preferred skills
DOE design and data analysis, Statistical process control (SPC), Multivariate analysis (MVA), Process analytical technologies (PAT), Data analytics, Computer modeling
Technologies
None explicitly listed as tools/frameworks
Responsibilities
Lead cross-functional vaccine drug product working groups for early and late pipeline programs; Drive process characterization, scale-up, transfer, and validation through filing and PPQ; Author and review regulatory submissions and support agency meetings; Provide mentorship and technical oversight to employees; Design and execute commercialization studies and new product introductions; Establish fit-for-purpose scale-down models and platform engineering models; Drive process optimization towards standardized platforms
Seniority
Senior, hands-on IC with strategic guidance
