Assoc Prin. Scientist, Analytical R&D (2nd Shift: Lead)
Merck
July 02, 2026
On-site
Rahway, NJ
Clinical Research and Development
Associate Principal Scientist 2nd Shift GMP Supervisor, Pharmaceutical Analytical Sciences (Fully onsite, 2nd shift 3pm–11:30pm).
Primary Responsibilities:
- Serve as scientific and operational supervisor for specialists/scientists supporting cleaning verification, solvent release, and in-process testing for drug substance and drug product (non-sterile clinical portfolio) during 2nd shift.
- Support GMP analytical activities including method validation and release testing.
- Document experiments (execution, procedures, results, conclusions) following ALCOA+ principles.
- Ensure on-time, right-first-time analytical testing to enable clinical manufacture.
- Provide technical/compliance oversight for lab investigations and deviations; troubleshoot as needed.
- Review/approve GMP data, analytical reports, and SOPs.
- Drive process improvements and operational excellence.
- Collaborate with Global Development Quality and Pharmaceutical Operations; support internal/external compliance audits.
Qualifications:
- BS/MS in chemistry or related science with at least 7 years industry experience in pharma drug substance/product development; or Ph.D. with at least 3 years.
Required Skills:
- Scientific communication; creativity; interpersonal/collaboration; ability to lead teams to meet deadlines; cross-functional partnership.
Preferred Skills:
- Prior experience managing a GMP analytical lab for cleaning verification, IPC, and solvent release; experience with investigations/deviations and compliance audits.
Required Skills (keywords): Analytical Method Development, Analytical Testing, GMP Compliance, Operational Excellence, Manufacturing Operations, Team Leadership, Science Communication, Cross-Functional Teamwork.
Apply: https://jobs.merck.com/us/en (Workday Jobs Hub for current employees).
Primary Responsibilities:
- Serve as scientific and operational supervisor for specialists/scientists supporting cleaning verification, solvent release, and in-process testing for drug substance and drug product (non-sterile clinical portfolio) during 2nd shift.
- Support GMP analytical activities including method validation and release testing.
- Document experiments (execution, procedures, results, conclusions) following ALCOA+ principles.
- Ensure on-time, right-first-time analytical testing to enable clinical manufacture.
- Provide technical/compliance oversight for lab investigations and deviations; troubleshoot as needed.
- Review/approve GMP data, analytical reports, and SOPs.
- Drive process improvements and operational excellence.
- Collaborate with Global Development Quality and Pharmaceutical Operations; support internal/external compliance audits.
Qualifications:
- BS/MS in chemistry or related science with at least 7 years industry experience in pharma drug substance/product development; or Ph.D. with at least 3 years.
Required Skills:
- Scientific communication; creativity; interpersonal/collaboration; ability to lead teams to meet deadlines; cross-functional partnership.
Preferred Skills:
- Prior experience managing a GMP analytical lab for cleaning verification, IPC, and solvent release; experience with investigations/deviations and compliance audits.
Required Skills (keywords): Analytical Method Development, Analytical Testing, GMP Compliance, Operational Excellence, Manufacturing Operations, Team Leadership, Science Communication, Cross-Functional Teamwork.
Apply: https://jobs.merck.com/us/en (Workday Jobs Hub for current employees).