Associate Principal Scientist, Analytical R&D (GxP Supervisor 2nd Shift)

MSD; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Benefits package

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking an Associate Principal Scientist to supervise a GMP analytical team on 2nd shift, delivering cleaning verification, method validation, solvent release, and in-process testing for drug substance and drug product.

The role emphasizes ALCOA+ documentation, on-time testing, and cross-functional collaboration with Global Development Quality and Pharmaceutical Operations to ensure compliance and timely clinical manufacturing support.

Qualifications

• BS or MS in chemistry or related science with at least 7 years of industry experience with pharmaceutical drug substance and/or product development.
• Ph.D. in chemistry or related science with at least 3 years of industry experience with pharmaceutical drug substance and/or product development.

Responsibilities

• Serve as a scientific and operational supervisor for a team of specialists and scientists supporting cleaning verification, solvent release, and in-process testing for drug substance and drug product during 2nd shift operations.
• Support execution of GMP analytical activities such as cleaning verification, method validation and in-process testing.
• Document the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA+ principles.
• Ensure on time, right first-time analytical testing to enable clinical manufacture of drug substance and drug product.
• Provide technical and compliance oversight for lab investigations and deviations and to troubleshoot in the lab as necessary.
• Review and approval of GMP data, analytical reports, and SOPs.
• Ensure operational excellence and drive process improvements.
• Work collaboratively with internal stakeholders and partners such as Global Development Quality and Pharmaceutical Operations.

Skills

Analytical Method Development

Analytical Testing

Assay Development

Biological Assay Development

Cell-Based Assays

Chromatographic Techniques

Cleaning Validations

Drug Development

HRMS

LC-MS

Pharmaceutical Process Development

PAT

Protein Analysis

Regulatory Compliance Audits

Education

BS or MS in chemistry or related science with at least 7 years of industry experience

Ph.D. in chemistry or related science with at least 3 years of industry experience

Job description

Job Description Role Summary

Join us and experience our culture firsthand - one of strong ethics & integrity, diversified experiences, exceptional science and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The Associate Principal Scientist will serve as the scientific and operational supervisor for a team of specialists and scientists in Rahway supporting various GMP analytical activities including cleaning verification, method validation, solvent release, and in-process testing for drug substance and drug product across the entirety of our non-sterile clinical portfolio during 2nd shift operations at the Rahway site. The role will also require hands-on analytical lab support to enable the pipeline.

Primary Responsibilities

• Serve as a scientific and operational supervisor for a team of specialists and scientists supporting cleaning verification, solvent release, and in-process testing for drug substance and drug product during 2nd shift operations.
• Support execution of Good Manufacturing Practices (GMP) analytical activities such cleaning verification, method validation and in-process testing.
• Document the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA+ principles.
• Ensure on time, right first-time analytical testing to enable clinical manufacture of drug substance and drug product.
• Provide technical and compliance oversight for lab investigations and deviations and to troubleshoot in the lab as necessary.
• Review and approval of GMP data, analytical reports, and SOPs.
• Ensure operational excellence and drive process improvements.
• Work collaboratively with internal stakeholders and partners such as Global Development Quality and Pharmaceutical Operations.
• Support internal and external compliance audit activities.

Qualifications

Education Minimum Requirements

• BS or MS in chemistry or related science with at least 7 years of industry experience with pharmaceutical drug substance and/or product development.
• Ph.D. in chemistry or related science with at least 3 years of industry experience with pharmaceutical drug substance and/or product development.

Required Experience and Skills

• Excellent scientific communication skills.
• Demonstrated creativity.
• Effective interpersonal and collaborative skills.
• Demonstrated ability to lead teams to deliver high-quality results against firm deadlines.
• Ability to partner in a team environment with cross-functional interactions to drive results.

Preferred Experience and Skills

• Prior experience managing a GMP analytical lab that supports cleaning verification.
• IPC, and solvent release.
• Prior experience with lab investigations/deviations and compliance audits is a plus.

Required Skills

• Analytical Method Development
• Analytical Testing
• Assay Development
• Biological Assay Development
• Cell-Based Assays
• Chromatographic Techniques
• Cleaning Validations
• Drug Development
• High Resolution Mass Spectrometry (HRMS)
• Liquid Chromatography-Mass Spectrometry (LC-MS)
• Pharmaceutical Process Development
• Process Analytical Technology (PAT)
• Protein Analysis
• Regulatory Compliance Audits

Inclusion and Equal Opportunity

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

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: EEOC Know Your Rights EEOC GINA Supplement

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.

Learn more about your rights, including under California, Colorado and other US State Acts

Compensation and Benefits

The primary location for this posting is: USA - New Jersey - Rahway.

Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $142,400.00 - $224,100.00. This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.

Additional Locations and Compensation Information

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

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.

Recruitment Policy

Search Firm Representatives Please Read Carefully 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.

Other Employment Details

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship: Yes

Travel Requirements: 10%

Flexible Work Arrangements: Not Applicable

Shift: 2nd - Evening

Valid Driving License: No

Hazardous Material(s): n/a

Job Posting Deadline

Job Posting End Date: 11/20/2026 · *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.

About the Company

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.