Manager, Process Operations

MSD • Rahway, NJ

3d • $117,000 - $184,200 • Onsite

About The Position

The Biologics Process Research & Development organization develops drug substance manufacturing processes for the company’s biologics pipeline, produces material for clinical trials, develops commercial processes and new technologies, and partners with Manufacturing to commercialize and launch products. This position supports the Next Generation Biologics (NGB) facility, a planned state-of-the-art, multi-product GMP facility at the company’s Rahway, New Jersey headquarters. The facility is designed to support development and pilot-scale operations, potent-material handling at small and large scales, and new technologies and cell-line platforms. The Manager, Process Operations supports the NGB Operations Leadership team and reports to the Associate Director of Production Operations.

The role leads upstream and downstream production operations, ensuring effective, compliant execution and a strong safety culture. It supports operational readiness and start-up of the facility, including equipment qualification, training, and MES implementation, and works cross-functionally on tech-transfer readiness and product-specific planning. The manager oversees production planning, develops direct reports, supports batch execution and timely lot release, and addresses operational and process issues. Off-hours, weekend, holiday, and on-call support may be required. The position is based primarily in Rahway, New Jersey, with 10% travel; flexible work arrangements are not applicable.

Requirements

• Bachelor’s degree in chemical or biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or a related discipline with at least 5 years of relevant experience; or a master’s degree with at least 3 years of relevant experience; or an associate’s degree with at least 10 years of relevant experience; or a high school diploma with at least 15 years of relevant experience.
• At least 5 years of experience in a GMP-regulated biologics drug substance manufacturing environment; single-use systems experience is preferred.
• 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.
• Ability to lift up to 25 lbs, if required.
• Required skills listed in the posting include competency management, data analysis, engineering standards, equipment maintenance, estimation and planning, impact analysis, maintenance supervision, manufacturing processes and improvements, operations management and support, packaging management, procedure writing, product formulation, production management and reports, quality management systems, regulatory compliance and requirements, root cause identification, safety standards, startup operations, and technical writing.

Nice To Haves

• Experience with facility fit assessments, new product introduction, process transfer to or from clinical sites, and clinical manufacturing.
• Experience with Veeva Quality Docs.
• Lean manufacturing and root cause analysis experience.
• Background in process engineering, upstream/downstream technical support, or biologics/vaccine manufacturing operations.
• Demonstrated ability to drive improvements and inspire others.
• Ability to use JMP, Microsoft Office, and project management software.
• Strong organizational, planning, communication, leadership, and presentation skills.
• Continuous improvement mindset and willingness to challenge the status quo.

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 one-on-ones, 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.

Benefits

• Medical, dental, and vision healthcare benefits and other insurance benefits for employees and families.
• Retirement benefits, including a 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager