Associate Principal Scientist, Sterile Drug Product Commercialization
$142.4k - $224.1kMerck
Merck seeks an Associate Principal Scientist to lead sterile drug product commercialization for biologics and combination products. The role encompasses process scale-up, technology transfer, process validation, and regulatory submissions for late-stage and commercial programs.
Responsibilities
- Lead cross-functional biologics drug product working groups through filing and Process Performance Qualification
- Design and execute drug product development, commercialization studies, and process validation at commercial sites
- Drive establishment of process characterization plans, control strategies, and scale-down models
- Author and review regulatory submissions and CMC sections; support agency meeting preparations
- Provide technical mentorship and strategic guidance to team members on complex scientific and technical issues
Requirements
- B.S. in chemical engineering, biochemistry, or related field with 10 years relevant experience; or Master's with 8 years; or Ph.D. with 4 years
- Experience with biologics drug product process development, optimization, and characterization
- Technical expertise in sterile fill-finish manufacturing processes for large molecules
- Experience with technology transfer and scale-up to pilot and manufacturing scales
- Excellent oral and written communication skills in multi-disciplinary team settings
- Working knowledge of regulatory requirements, Quality by Design, and cGMPs for sterile products
- Familiarity with statistical methods for DOE, SPC, MVA, or PAT techniques
Vacancy posted 3 days ago
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