Senior Scientist – Process Analytical Technology (On-site)
Merck
August 31, 2026
On-site
Rahway, NJ
Operations
Senior Scientist - Process Analytical Technologies (PAT)
Responsibilities:
- Provide technical leadership for systematic assessment and deployment of in-line, on-line, and at-line PAT methods for API and biologics drug substance development.
- Partner with process chemistry teams to define mechanistic questions, design hypothesis-driven studies, and translate insights into process development recommendations.
- Use PAT for reaction monitoring, kinetic assessment, intermediate identification, impurity profiling, and structure confirmation.
- Design and develop standardized analytical platforms for real-time monitoring and rapid shop-floor analytics.
- Develop, validate, and implement PAT methods to monitor/control process parameters and product quality attributes.
- Lead scale-up and technology transfer of PAT applications to commercial manufacturing.
- Create integrated control strategies leveraging PAT to enable robust, highly capable manufacturing.
- Prepare/maintain scientific documentation and validation packages; contribute content for regulatory submissions.
- Interact with global regulatory agencies to support acceptance of PAT-based control and release strategies.
Qualifications:
Required:
- B.S./M.S. in chemistry/related field with 3+ years industry experience; or Ph.D. with 0+ years.
- Strong organic reaction mechanism elucidation background for API process development.
- Optical spectroscopy (Raman, FTIR, NIR), NMR, chromatography, and chemometrics.
Preferred:
- Peer-reviewed scientific contributions.
- Experience in pharmaceutical/fine chemical process development, mechanistic understanding, optimization, scale-up troubleshooting, control strategies, robustness studies.
- Strong collaboration across functions and with external partners.
Required Skills:
- Analytical Method Development, Assay Development, Chromatographic Techniques, GMP Environments, NMR Analysis, Process Analytical Technology (PAT), Technical Writing, UPLC.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee).
Responsibilities:
- Provide technical leadership for systematic assessment and deployment of in-line, on-line, and at-line PAT methods for API and biologics drug substance development.
- Partner with process chemistry teams to define mechanistic questions, design hypothesis-driven studies, and translate insights into process development recommendations.
- Use PAT for reaction monitoring, kinetic assessment, intermediate identification, impurity profiling, and structure confirmation.
- Design and develop standardized analytical platforms for real-time monitoring and rapid shop-floor analytics.
- Develop, validate, and implement PAT methods to monitor/control process parameters and product quality attributes.
- Lead scale-up and technology transfer of PAT applications to commercial manufacturing.
- Create integrated control strategies leveraging PAT to enable robust, highly capable manufacturing.
- Prepare/maintain scientific documentation and validation packages; contribute content for regulatory submissions.
- Interact with global regulatory agencies to support acceptance of PAT-based control and release strategies.
Qualifications:
Required:
- B.S./M.S. in chemistry/related field with 3+ years industry experience; or Ph.D. with 0+ years.
- Strong organic reaction mechanism elucidation background for API process development.
- Optical spectroscopy (Raman, FTIR, NIR), NMR, chromatography, and chemometrics.
Preferred:
- Peer-reviewed scientific contributions.
- Experience in pharmaceutical/fine chemical process development, mechanistic understanding, optimization, scale-up troubleshooting, control strategies, robustness studies.
- Strong collaboration across functions and with external partners.
Required Skills:
- Analytical Method Development, Assay Development, Chromatographic Techniques, GMP Environments, NMR Analysis, Process Analytical Technology (PAT), Technical Writing, UPLC.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee).