Scientist, Engineering
Merck
June 30, 2026
On-site
West Point, PA
Clinical Research and Development
Scientist, Sterile Drug Product Commercialization
On-site presence required at West Point, PA. Travel up to 10% (must be able to travel).
Responsibilities:
- Serve on DP process characterization teams; design and execute multivariate product/process development studies.
- Support DP working groups and DP activities through filing and Process Performance Qualification (PPQ), including registration stability, process characterization plans, tech transfer control strategy, PPQ readiness, PAI readiness, approval, launch, and post-launch support.
- Ensure commercialization programs meet science, quality, reliability, schedule, and cost requirements.
- Design and execute DP commercialization studies, new product introductions, and process validation at commercial sites.
- Develop fit-for-purpose scale-down models; establish and validate platform engineering/scientific models for sterile products/process commercialization.
- Innovate and drive best practices for commercial site tech transfer, facility fit, and DP control strategy (classification of process parameters/performance parameters, operating ranges, in-process controls).
- Contribute to a culture of high performance, innovation, learning, empowerment, and inclusion.
Minimum Education:
- B.S. (Chemical/Biochemical/Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related) + 2 years relevant experience; or M.S. in related field.
Required Experience/Skills:
- Excellent oral/written communication; ability to articulate process science to drive decisions, impact assessments, and study design in a multidisciplinary team.
Preferred:
- Process characterization/optimization, scale-up, and tech transfer of sterile products to pilot/commercial.
- Combination product development knowledge.
- Working knowledge of cGMPs/regulatory requirements and ICH Quality norms.
- Statistical methods (DOE, data analysis), SPC, MVA, and/or PAT.
- Analytical methods knowledge for vaccines/biologics/sterile drug products.
Required skills (includes): biochemistry/biopharmaceuticals, downstream & upstream development, process scale up/validation, GMP compliance, technical writing, technology transfer, data analysis, experimentation, interdisciplinary collaboration, platform engineering, microbiology, SPC.
Apply: Submit application at https://jobs.merck.com/us/en (deadline listed on the posting).
On-site presence required at West Point, PA. Travel up to 10% (must be able to travel).
Responsibilities:
- Serve on DP process characterization teams; design and execute multivariate product/process development studies.
- Support DP working groups and DP activities through filing and Process Performance Qualification (PPQ), including registration stability, process characterization plans, tech transfer control strategy, PPQ readiness, PAI readiness, approval, launch, and post-launch support.
- Ensure commercialization programs meet science, quality, reliability, schedule, and cost requirements.
- Design and execute DP commercialization studies, new product introductions, and process validation at commercial sites.
- Develop fit-for-purpose scale-down models; establish and validate platform engineering/scientific models for sterile products/process commercialization.
- Innovate and drive best practices for commercial site tech transfer, facility fit, and DP control strategy (classification of process parameters/performance parameters, operating ranges, in-process controls).
- Contribute to a culture of high performance, innovation, learning, empowerment, and inclusion.
Minimum Education:
- B.S. (Chemical/Biochemical/Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related) + 2 years relevant experience; or M.S. in related field.
Required Experience/Skills:
- Excellent oral/written communication; ability to articulate process science to drive decisions, impact assessments, and study design in a multidisciplinary team.
Preferred:
- Process characterization/optimization, scale-up, and tech transfer of sterile products to pilot/commercial.
- Combination product development knowledge.
- Working knowledge of cGMPs/regulatory requirements and ICH Quality norms.
- Statistical methods (DOE, data analysis), SPC, MVA, and/or PAT.
- Analytical methods knowledge for vaccines/biologics/sterile drug products.
Required skills (includes): biochemistry/biopharmaceuticals, downstream & upstream development, process scale up/validation, GMP compliance, technical writing, technology transfer, data analysis, experimentation, interdisciplinary collaboration, platform engineering, microbiology, SPC.
Apply: Submit application at https://jobs.merck.com/us/en (deadline listed on the posting).