Lead Scientist, Process Development & Commercialization
Merck
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Job summary
Merck seeks a highly motivated scientist/engineer to advance late-stage small molecule programs from development to commercialization. The Principal Scientist, Engineering leads process characterization, technology transfer to manufacturing sites, and regulatory filing support while mentoring staff across Merck's global network.
You will apply DOE, QbD, and risk management within cGMPs to ensure safe, scalable manufacturing processes and collaborate across functions to influence development
Qualifications
- Bachelor's or master's degree in chemical engineering or a related scientific discipline with 11+ years of relevant experience, or a PhD with 7+ years
- Experience leading process development, characterization, and scale-up activities in pharma manufacturing
- Experience supporting regulatory filing strategies and technology transfers to commercial sites
Responsibilities
- Lead and oversee process characterization activities to develop robust manufacturing processes
- Drive regulatory filing support, including control strategy development and process validation planning/execution
- Mentor and develop technical staff through lab execution, data analysis, and problem solving
- Collaborate with cross-functional teams to drive complex development programs and decision making
- Apply QbD, DOE, and risk management principles to ensure compliant manufacturing
- Lead technology transfer activities to commercial manufacturing sites
Skills
Education
Job description
Merck seeks a highly motivated scientist/engineer to advance late-stage small molecule programs from development to commercialization. The Principal Scientist, Engineering leads process characterization, technology transfer to manufacturing sites, and regulatory filing support while mentoring staff across Merck's global network.
You will apply DOE, QbD, and risk management within cGMPs to ensure safe, scalable manufacturing processes and collaborate across functions to influence development
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