Associate Scientist Engineering
Merck
Associate Scientist supporting vaccine and sterile drug product commercialization within manufacturing. Responsibilities include process development, technology transfer, regulatory submissions, and commercialization studies from development through commercial launch.
Responsibilities
- Support cross-functional teams from process development through Process Performance Qualification and regulatory filing
- Design, author, and execute drug product commercialization studies and technical documents
- Develop scale-down models and establish control strategies for commercial site technology transfer
- Manage project timelines and ensure commercialization programs meet quality, safety, and cost requirements
- Contribute to best practices and innovation in sterile product manufacturing and process validation
Requirements
- Bachelor's degree or higher in Chemical Engineering, Biochemical Engineering, or related field
- Excellent oral and written communication skills
- Ability to articulate process science concepts to cross-functional teams
- Experience with large molecule drug product process characterization and scale-up
- Working knowledge of cGMP regulations and ICH Quality standards
- Familiarity with statistical methods for DOE, SPC, and process analytical technologies
Vacancy posted 1 day ago
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