Biologics Process Operations Manager

Merck; Rahway (NJ); On-site; USD 117,000 - 184,200; Full time

Benefits offered by this job

Medical benefits

401(k) retirement plan

Paid holidays

Job summary

Merck & Co., Inc. in Rahway, NJ, seeks a Manager, Process Operations to lead upstream/downstream production, drive cGMP/EHS compliance, and support tech transfer for a new GMP facility within the NGB hub. The role reports to the Associate Director of Production Operations.

Ideal candidates have 5+ years in GMP biologics manufacturing, and experience leading teams, SOPs, and equipment qualification. This on-site role offers a comprehensive benefits package and annual bonus eligibility.

Qualifications

• Bachelor’s degree in chemical/biochemical eng, pharma sciences, chemistry, biology with 5+ years exp.
• Or Master’s degree with 3+ years exp in relevant field.

Responsibilities

• Lead a team executing upstream and downstream production operations.
• Assign daily work and ensure effective execution, accountability, and compliance.
• Drive cGMP and EHS compliance and promote a strong safety culture.
• Maintain a strong floor presence during GMP operations and support critical tasks as needed.
• Ensure team qualification, training completion, and MyLearning compliance.
• Support operational readiness activities for launch of the new GMP facility.
• Participate in interviews and hiring activities as needed.
• Coach and develop direct reports through regular 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 and process issues and 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, and on-call support as needed.
• Support start-up activities including equipment qualification, training curricula, staff training, and MES implementation.
• Oversee production planning and associated activities.
• Partner cross-functionally to support operational readiness for tech transfer programs, including product-specific planning and quality risk assessments.
• Collaborate across the network to share best practices and promote operational consistency.

Skills

Analytical Testing

Data Analysis

Deviation Management

Equipment Qualification

GMP Compliance

Lean Manufacturing

Microbiology

Molecular Microbiology

Process Design

PHA

Process Optimization

Production Management

Production Operations

Production Planning

Root Cause Analysis

Technical Leadership

Education

Bachelor’s degree in chemical/biochemical engineering, pharma sciences, chemistry, biochemistry, biology, microbiology or related with 5+ years exp

Master’s degree with 3+ years exp in relevant field

Tools

DeltaV

MES

SAP

Job description

Merck & Co., Inc. in Rahway, NJ, seeks a Manager, Process Operations to lead upstream/downstream production, drive cGMP/EHS compliance, and support tech transfer for a new GMP facility within the NGB hub. The role reports to the Associate Director of Production Operations.

Ideal candidates have 5+ years in GMP biologics manufacturing, and experience leading teams, SOPs, and equipment qualification. This on-site role offers a comprehensive benefits package and annual bonus eligibility.