Manager, Process Operations
$117,000–$184,200 year
On-siteRahway, New Jersey, United States
Job Summary
Lead a team executing upstream and downstream production operations, assigning daily work to ensure effective execution, accountability, and cGMP and EHS compliance. Maintain a strong floor presence during GMP operations, drive Right First Time batch execution, and troubleshoot technical issues to make timely operational decisions. Support operational readiness activities for the launch of the new GMP facility in Rahway, NJ, including equipment qualification, training curricula, staff training, and MES implementation. Provide off-hours, weekend, holiday, and on-call support as needed while authoring, revising, and approving SOPs and batch records. Coach and develop direct reports through regular 1:1s, feedback, and performance reviews to foster a strong safety culture and operational excellence.
Required Qualifications
- Bachelor's degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline
- Minimum of 5 years relevant experience
- 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
- Valid Driving License
- Ability to lift up to 25 lbs, if required
Desired Qualifications
- Experience with facility fit assessments
- New product introduction
- Process transfer to/from clinical sites
- 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
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