Operations Lead (Shop Floor Supervisor)
About The Position
The Modality Agnostic Chemistry Scaleup (MACS) group within the Chemical Engineering Research & Development (CERD) Department is seeking an operations professional for its new potent, multimodality drug-substance development and GMP clinical manufacturing facility under construction in Rahway, New Jersey. The role supports the MACS Center from testing and startup through full operations and may also support other new or existing facilities across the Small Molecule Process Research & Development network, including the Small Scale Organics Pilot Plant and Prep Lab. During construction and startup, the position contributes to equipment and facility design, system commissioning and qualification, and other activities needed to prepare the facility for operation. The role supervises and participates in daily production, prioritizes and assigns work to operations staff, and helps ensure compliance with Safety and Environmental requirements and GMP quality standards. It supports facility readiness for active pharmaceutical ingredient processing, implements process improvements, and shares accountability for facility performance. The position works with MACS leadership and cross-functional partners to support the facility’s objectives and customer requirements, while fostering collaboration, learning, and innovation. The position requires weekly rotation between first and second shift as the building transitions toward equipment qualification and operations. The employee may coordinate maintenance around processing activities and work with automation systems such as DeltaV and PLCs. The role reports to the Associate Director, MACS Operations. The posting lists an annual salary range of $87,300–$137,400 for the primary Rahway location, with eligibility for an annual bonus and long-term incentive if applicable.
Requirements
- Bachelor's degree in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or a related engineering or scientific discipline, with at least 2 years of relevant experience in a process development lab, pilot plant/manufacturing facility, or other operations environment; alternatively, a high school diploma with at least 6 years of relevant experience in a process development lab or pilot plant/manufacturing facility.
- Mechanical aptitude and familiarity with chemical process development and process equipment.
- Experience supervising a team of shop-floor personnel in an operations environment.
- Understanding of and experience with current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), and Safety and Environmental (S&E) regulations.
- Experience operating or maintaining manufacturing-scale, pilot-scale, and/or laboratory-scale equipment.
- Effective communication skills and a collaborative mindset.
- Experience with conflict resolution and root cause analyses.
- Ability to build effective work relationships with a varied workforce and adapt to a dynamic production environment.
- Ability to rotate between first and second shifts weekly as the building transitions toward equipment qualifications and operations.
- Willingness to learn, contribute, and lead.
- Experience working with automation systems such as DeltaV and PLCs.
- Required skills listed: cGMP Guidelines, Competency Management, Corrective Action Management, Electronic Batch Records, Manpower Planning, Manufacturing Processes, Pilot Plant Operations, Process Engineering, Root Cause Identification, Root Cause Investigations, and Troubleshooting.
Nice To Haves
- Experience with GMP facility design, equipment startup, and/or qualification.
- Small-molecule drug-substance and/or biologics process development experience.
- Experience supporting compliance investigations and change management.
- Experience with Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA).
- Experience with potent-compound processing and containment systems such as isolators.
- Experience interacting with process utility systems associated with a large drug-substance pilot plant, including WFI generation and distribution, process chillers, and vacuum systems.
- Experience with quality-systems notifications, Root Cause Analysis (RCA), Corrective Action Preventative Action (CAPA), quality change controls, and/or safety Management of Change (MOC).
Responsibilities
- Supervise and participate in daily production activities while ensuring compliance with Safety, GMP Quality, and Environmental requirements.
- Prioritize and assign daily activities for operations staff.
- Contribute to equipment and facility design, system commissioning and qualification, and other workstreams supporting facility startup.
- Ensure facility readiness for API processing and share accountability for facility performance.
- Implement process improvement actions to meet Safety and Environmental and GMP requirements.
- Work cooperatively with MACS leadership and cross-functional partners to advance facility performance and meet objectives and customer requirements.
- Coordinate maintenance activities around processing activities to support reliable facility operation.
- Support other new or existing facilities across the Small Molecule Process Research & Development network as required.
Benefits
- Medical, dental, and vision healthcare benefits and other insurance benefits for employees and their families.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, and compassionate and sick days.
- Eligibility for an annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
