Senior Scientist – Process Analytical Technology (On-site)

MSD Malaysia; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Relocation assistance

Healthcare benefits

Job summary

Merck & Co. is seeking a Senior Scientist to lead Process Analytical Technologies (PAT) activities within Analytical Enabling Capabilities, applying mechanistic chemistry and PAT tools to support API process development from development to manufacturing.

The role emphasizes in-line/online/at-line monitoring, experimental design, and cross-functional collaboration with process chemistry teams. Expect involvement in regulatory documentation and technology transfer across facilities.

Qualifications

• B.S./M.S. in chemistry, biochemistry, biotechnology, bioengineering, chemical engineering, or related discipline with 3+ years of industry experience; Ph.D. also acceptable.
• Strong background in elucidation of organic reaction mechanisms as applied to API process development.
• Strong 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 with process chemistry teams to define mechanistic questions and translate insights into process development recommendations.
• Apply PAT to monitor reaction kinetics, intermediates, impurity profiling, and structure confirmation during API development.
• Design standardized analytical platforms enabling PAT implementation with real-time monitoring and rapid shop-floor analytics.
• Develop, validate, and implement PAT methods to monitor process parameters and product quality attributes.
• Lead scale-up activities and technology transfer of PAT applications to commercial manufacturing.
• Create integrated control strategies leveraging PAT for robust manufacturing.
• Prepare scientific documentation and regulatory submission content.

Skills

Analytical Method Development

Assay Development

Chromatographic Techniques

NMR Analysis

Process Analytical Technology

UPLC

GMP Environments

Technical Writing

Education

B.S./M.S. in chemistry or related field

Ph.D. (preferred)

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

• 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)

EligibleforERP ARD

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.

Benefits

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.

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

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.

Equal Opportunity & Diversity

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.

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.