Manager, Process Operations
Merck
August 14, 2026
On-site
Rahway, NJ
Operations
Job Responsibilities:
- Lead a team executing upstream and downstream production operations.
- Assign daily work; ensure effective execution, accountability, and compliance.
- Drive cGMP and EHS compliance; maintain strong safety culture and GMP floor presence.
- Ensure team qualification, training completion, and MyLearning compliance.
- Support operational readiness for launch of a new GMP facility.
- Participate in interviews and hiring; coach and develop direct reports via 1:1s, feedback, and performance reviews.
- Drive Right First Time (RFT) batch execution and operational excellence.
- Review documentation in real time to support timely lot release.
- Troubleshoot technical/process issues; make timely operational decisions.
- Initiate deviations, perform initial impact assessments, and support investigations.
- Author, revise, and approve SOPs, batch records, work instructions, and memos.
- Provide off-hours/weekend/holiday/on-call support as needed.
- Support start-up activities (equipment qualification, training curricula, staff training, MES implementation).
- Oversee production planning.
- Partner cross-functionally for operational readiness for tech transfer, including quality risk assessments.
- Collaborate across the network to share best practices and promote operational consistency.
Required Education/Experience:
- Bachelor’s in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related + 5+ years relevant experience; or Master’s + 3+ years relevant experience.
Required Skills/Experience:
- 5+ years in GMP-regulated biologics drug substance manufacturing (preferably single-use systems).
- Prior experience leading operations teams.
- Strong GMP (upstream/downstream) knowledge; working knowledge of cGMP, Quality Systems, and EHS.
- Ability to train employees; experience writing SOPs/technical documents.
- Working knowledge of DeltaV, MES, and SAP.
- Strong troubleshooting/decision-making and attention to detail.
Preferred Skills/Experience:
- Facility fit assessments; new product introduction; process transfer/clinical manufacturing.
- Veeva Quality Docs; lean manufacturing/root cause analysis.
- Tools: JMP, Microsoft Office, project management software; strong leadership/communication.
Benefits:
- Eligible for annual bonus and long-term incentive (if applicable). Comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.
- Lead a team executing upstream and downstream production operations.
- Assign daily work; ensure effective execution, accountability, and compliance.
- Drive cGMP and EHS compliance; maintain strong safety culture and GMP floor presence.
- Ensure team qualification, training completion, and MyLearning compliance.
- Support operational readiness for launch of a new GMP facility.
- Participate in interviews and hiring; coach and develop direct reports via 1:1s, feedback, and performance reviews.
- Drive Right First Time (RFT) batch execution and operational excellence.
- Review documentation in real time to support timely lot release.
- Troubleshoot technical/process issues; make timely operational decisions.
- Initiate deviations, perform initial impact assessments, and support investigations.
- Author, revise, and approve SOPs, batch records, work instructions, and memos.
- Provide off-hours/weekend/holiday/on-call support as needed.
- Support start-up activities (equipment qualification, training curricula, staff training, MES implementation).
- Oversee production planning.
- Partner cross-functionally for operational readiness for tech transfer, including quality risk assessments.
- Collaborate across the network to share best practices and promote operational consistency.
Required Education/Experience:
- Bachelor’s in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related + 5+ years relevant experience; or Master’s + 3+ years relevant experience.
Required Skills/Experience:
- 5+ years in GMP-regulated biologics drug substance manufacturing (preferably single-use systems).
- Prior experience leading operations teams.
- Strong GMP (upstream/downstream) knowledge; working knowledge of cGMP, Quality Systems, and EHS.
- Ability to train employees; experience writing SOPs/technical documents.
- Working knowledge of DeltaV, MES, and SAP.
- Strong troubleshooting/decision-making and attention to detail.
Preferred Skills/Experience:
- Facility fit assessments; new product introduction; process transfer/clinical manufacturing.
- Veeva Quality Docs; lean manufacturing/root cause analysis.
- Tools: JMP, Microsoft Office, project management software; strong leadership/communication.
Benefits:
- Eligible for annual bonus and long-term incentive (if applicable). Comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.