Senior Scientist - Process Analytical Technology (On-site)

Merck & Co.; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck & Co., Rahway, NJ, seeks a Senior Scientist to advance Process Analytical Technologies (PAT) across API process development and manufacturing. The role focuses on reaction mechanism elucidation, in-line monitoring, and impurity profiling with strong emphasis on collaborative problem solving.

You will lead PAT method development, integrate real-time analytics, and support scale-up and regulatory documentation. A chemistry background with spectroscopy expertise is essential for success.

Qualifications

• BS/MS with a minimum of 3 years of relevant industry experience; or PhD with 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.

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.

Skills

Analytical Method Development

Assay Development

Chromatographic Techniques

GMP Environments

NMR Analysis

PAT

Technical Writing

UPLC

Education

Bachelor's/Master's in Chemistry or related field

PhD in a related field

Tools

Raman spectroscopy

FTIR spectroscopy

NIR spectroscopy

NMR spectroscopy

Chromatography

Job description

Senior Scientist - Process Analytical Technologies (PAT)

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.

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.

Qualifications

Required

• 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.

Preferred

• 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.

Required Skills

• 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)

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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Salary

The salary range for this role is $117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

laboratory chemicals

Job Posting End Date

09/14/2026

*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R415024