Associate Principal Scientist, Sterile Drug Product Commercialization
Core
Lead technical process leadership and laboratory capabilities for late-stage and commercial drug product processes for biologics and combination products, focusing on process scale-up, technology transfer, and validation.
Role type
Senior IC Associate Principal Scientist (Biologics Commercialization)
Builds
Sterile biologics drug products for commercial launch
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
Bioprocessing, Commercialization, Drug Product Manufacturing, Manufacturing Process Validation, Manufacturing Scale-Up, Process Improvements, Product Commercialization, Protein Purifications, Regulatory Submissions, Technical Transfer, Technology Transfer
Preferred skills
Potent and sterile drug product operations, Late-stage commercialization, Quality by Design, cGMPs, Statistical methods (DOE, SPC, MVA), Data Analytics, Computer Modeling
Technologies
None explicitly listed as tools/frameworks
Responsibilities
Lead cross-functional biologics drug product working groups through filing and PPQ; Ensure commercialization programs meet science, quality, reliability, schedule, and cost requirements; Drive strategic initiatives for efficient commercialization; Provide mentorship and technical oversight to employees; Develop process and product development plans; Design and execute DP development and commercialization studies; 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 continuous process optimization towards standardized platforms.
Seniority
Senior, hands-on IC with mentorship responsibilities