Principal Scientist, Engineering - Sterile Drug Product Commercialization, Biologics
Core
Lead technical process leadership and laboratory capabilities for late-stage and commercial drug product processes for biologics, focusing on scale-up, technology transfer, and process validation.
Role type
Principal Scientist, Biologics Commercialization
Builds
Sterile biologics drug products and combination products for commercial launch
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biologics process development, Scale-up and technology transfer, Process validation (PPQ), Regulatory submission authoring, Process characterization, Sterile fill-finish operations, Cross-functional team leadership, Strategic initiative driving, Mentorship, New product introduction planning
Preferred skills
Potent and sterile drug product operations, Quality by Design (QbD) principles, Statistical process control (SPC) and DOE, Process analytical technologies (PAT), Digital applications in manufacturing
Technologies
None explicitly listed beyond general tools implied in skills
Responsibilities
Execute oversight of biologics product and process design, development, and commercial validation; Lead cross-functional working groups through filing and PPQ; Drive strategic initiatives for efficient commercialization; Provide mentorship and technical guidance on non-routine issues; Develop process and product development plans; Design and execute commercialization studies and validation at commercial sites; Establish fit-for-purpose scale-down models and platform engineering; Innovate best practices for tech transfer and control strategy; Influence CMC regulatory strategy and author regulatory submissions; Drive process optimization towards standardized platforms.
Seniority
Principal, hands-on IC with strategic mentorship