Senior Scientist – Process Analytical Technology (On-site)

MerckRahway, NJ
$117,000 - $184,200Onsite

About The Position

We are seeking a Senior Scientist to join the Process Analytical Technologies (PAT) team within Analytical Enabling Capabilities at our company. As a member of the PAT team, you will integrate with a motivated and inclusive team of expert scientists passionate about PAT tools application from process development to routine manufacturing. This role offers an exciting opportunity to contribute strong mechanistic organic chemistry expertise to support small molecule active pharmaceutical ingredient (API) process development, with a particular emphasis on reaction mechanism elucidation, reaction monitoring, and impurity understanding.

Requirements

  • B.S./M.S in chemistry, biochemistry, biotechnology, bioengineering, chemical engineering, or a related discipline with a minimum of 3 years of relevant industry experience; or Ph.D. and 0+ years.
  • Strong technical background in elucidation of organic reaction mechanisms as applied to API process development.
  • Strong technical background in optical spectroscopy (Raman, FTIR, NIR), NMR, chromatography, and chemometrics.
  • Analytical Method Development
  • Assay Development
  • Chromatographic Techniques
  • GMP Environments
  • Nuclear Magnetic Resonance (NMR) Analysis
  • Process Analytical Technology (PAT)
  • Technical Writing
  • Ultra Performance Liquid Chromatography (UPLC)

Nice To Haves

  • Proven track record of scientific contributions (peer-reviewed publications or equivalent technical outputs).
  • Experience supporting pharmaceutical or fine chemical process development, including mechanistic understanding, process optimization, scale-up troubleshooting, control strategy development, and robustness studies.
  • Strong collaborative and interpersonal skills; ability to work across functions and with external partners.

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 programs.
  • Partner closely with process chemistry teams to define mechanistic questions, design hypothesis-driven studies, and translate mechanistic insights into actionable process development recommendations.
  • Apply PAT to support reaction monitoring, kinetic assessment, intermediate identification, impurity profiling, and structure confirmation during API process development.
  • Design and develop standardized analytical platforms to enable PAT implementation, including real-time monitoring and rapid shop-floor analytics.
  • Develop, validate, and implement PAT methods (in-line, on-line, at-line) to monitor and control process parameters and product quality attributes.
  • Lead scale-up activities and technology transfer of PAT applications to commercial manufacturing.
  • Create integrated control strategies that leverage PAT platforms to enable robust, highly capable manufacturing processes.
  • Prepare and maintain scientific documentation and validation packages for PAT methods; contribute content for regulatory submissions.
  • Interact with global regulatory agencies as needed to support acceptance of PAT-based process control and release strategies.

Benefits

  • medical, dental, vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days
  • annual bonus
  • long-term incentive

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What This Job Offers

Job Type

Full-time

Career Level

Senior

Education Level

Ph.D. or professional degree

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