Manager, Process Operations

About the Role

The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical, and Early Development to rapidly develop processes for different biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.

This role will support the Next Generation Biologics (NGB) facility, which will be a premier, state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. This facility will be fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It can meet all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot scale, small and large scale potent material handling, and the ability to integrate new technologies and cell-line platforms.

The Manager, Process Operations, will support the NGB Operations Leadership team, reporting to the Associate Director of Production Operations.

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.

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.

Experience & Skills

• 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.

Preferred Experience & Skills

• Experience with facility fit assessments, new product introduction, process transfer to/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 tools such as 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.
• Ability to lift up to 25 lbs, if required.

Pay

The salary range for this role is $117,000.00 - $184,200.00. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays, vacation, and compassionate and sick days

Schedule

Flexible work arrangements available. Off-hours, weekend, holiday, and on-call support required as needed.