Biologics Process Operations Lead — GMP & Startup Ready

MSD

Rahway (NJ)

On-site

USD 117,000 - 184,000

Full time

14 days+

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Job summary

Merck & Co., Inc. in Rahway, NJ, seeks a senior leader to direct upstream/downstream biologics production operations. You will drive cGMP compliance, staff development, and RFT performance while supporting tech transfers for a multi-product GMP facility.

The role requires 5+ years in GMP biologics with single‑use systems experience and strong technical leadership for a fast-paced environment.

Qualifications

Bachelor’s degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 5 years relevant experience, or a Master’s degree with minimum 3 years of relevant experience.
Minimum 5 years of experience in a GMP-regulated biologics drug substance manufacturing environment, preferably with single-use systems.
Prior experience leading operations teams and monitoring performance.
Strong understanding of GMP manufacturing environments, including upstream and downstream processing.
Working knowledge of cGMP, Quality Systems, and EHS requirements.
Ability to train employees in technical, compliance, safety, and environmental procedures.
Experience writing SOPs and technical documents.
Working knowledge of DeltaV, MES, and SAP.
Strong troubleshooting, decision-making, and attention to detail skills.
Demonstrated initiative and ability to work effectively in a fast‑paced environment.

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

Fast-Paced Environments

GMP Compliance

Lean Manufacturing

Microbiology

Molecular Microbiology

Pharmaceutical Sciences

Process Design

Process Hazard Analysis (PHA)

Process Optimization

Production Management

Production Operations

Production Planning

Root Cause Analysis (RCA)

Technical Leadership

Education

Bachelor’s degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 5 years relevant experience, or a Master’s degree with minimum 3 years of relevant experience