Operations Lead (Shop Floor Supervisor)

MSD•Rahway, NJ

1d•$87,300 - $137,400•Onsite

About The Position

The Modality Agnostic Chemistry Scaleup (MACS) group within the Chemical Engineering Research & Development Department is seeking an operations professional for its new potent, multimodality drug-substance development and GMP clinical manufacturing facility in Rahway, New Jersey. The position will be part of the MACS Operations Team and report to the Associate Director, MACS Operations. The facility is under construction, and the selected candidate will contribute to equipment and facility design, system commissioning and qualification, and other activities needed for startup. The role will support the facility from testing and startup through full operation and may also support other facilities in the Small Molecule Process Research & Development network. At the Specialist level, the position will supervise and participate in daily production activities, ensure compliance with Safety & Environmental and GMP requirements, and help meet facility objectives and customer requirements. The role prioritizes and assigns daily work for operations staff, implements process improvements, supports facility readiness for active pharmaceutical ingredient processing, and shares accountability for facility performance. The successful candidate will work collaboratively with MACS leadership and cross-functional partners to support safe, reliable operations and a culture of learning, collaboration, and innovation. The position may also support the Small Scale Organics Pilot Plant and Prep Lab. The pilot plant supports GMP clinical manufacture and first pilot production of small-molecule processes, while the Prep Lab generates process-definition data and, when needed, Phase I/IIa clinical material. The Prep Lab also supports scale-up and flexible processing of potent and cross-modality compounds.

Requirements

Bachelor's degree in Chemical Engineering, Materials Science or 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 or 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 & Environmental 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.
Adaptability to a dynamic production environment.
Ability to rotate between first and second shifts weekly as required during the facility transition.
Willingness to learn, contribute, and lead.
Ability to coordinate maintenance activities around processing activities.
Experience working with automation systems such as DeltaV and PLCs.
Skills in cGMP guidelines, competency management, corrective action management, electronic batch records, manpower planning, manufacturing processes, pilot plant operations, process engineering, root-cause identification and investigations, and troubleshooting.

Nice To Haves

Experience with GMP facility design, equipment startup, and/or qualification.
Experience in small-molecule drug-substance and/or biologics process development.
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 at a large drug-substance pilot plant, including WFI generation and distribution, process chillers, and vacuum systems.
Experience with quality-system notifications, Root Cause Analysis (RCA), Corrective Action Preventative Action (CAPA), quality change controls, and/or safety Management of Change (MOC).

Responsibilities

Contribute to facility and equipment design, system commissioning and qualification, and other facility-startup workstreams.
Serve as an operations team member from facility testing and startup through full operation.
Supervise and participate in daily production activities while ensuring compliance with Safety & Environmental, GMP Quality, and environmental requirements.
Prioritize and assign daily activities for operations staff.
Implement process-improvement actions to meet Safety & Environmental and GMP requirements.
Ensure facility readiness for active pharmaceutical ingredient processing and share accountability for facility performance.
Coordinate maintenance activities around processing to support reliable facility operation.
Collaborate with MACS leadership and cross-functional partners to support the overall success and performance of the facility.
As required, provide support to other facilities and areas, including the Small Scale Organics Pilot Plant and Prep Lab.
Rotate between first and second shifts on a weekly basis as the facility transitions toward equipment qualification and operations.