Lead GMP Analytical Scientist – 2nd Shift (Drug Substance/Product)

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

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.