Operations Lead (Shop Floor Supervisor)

MSD • Rahway, NJ

5d • Onsite

About The Position

The Modality Agnostic Chemistry Scaleup (MACS) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides pilot plant operations experience and a strong understanding of engineering fundamentals. The Process Supervisor position will report to the Associate Director, MACS Operations and will be a member of the MACS Operations Team at the Rahway, NJ facility. The process supervisor role at the Specialist level will serve as an operations team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently under construction in Rahway, New Jersey. The Specialist will serve as a team member from testing and startup through to when the MACS facility is fully operational. They will also potentially support other new and/or existing facilities across the Small Molecule Process Research & Development (SM PR&D) network. As the facility is currently under construction, the selected candidate will contribute to equipment and facility design, system commissioning/qualification, as well as other critical activity workstreams to enable facility startup. The selected candidate is expected to be a key part of an operations team and foster a culture of collaboration, learning and innovation. The incumbent will supervise and participate in daily production activities while ensuring compliance with Safety, GMP Quality, and Environmental requirements to meet MACS objectives and customer requirements. This role will also be responsible for the prioritization and assignment of daily activities for the operations staff. The position is responsible for implementing process improvement actions to meet S&E (Safety & Environmental) and GMP requirements. This position is also responsible for ensuring facility readiness for API (Active Pharmaceutical Ingredient) processing and shares accountability for the facility’s performance. Ultimately, this position is expected to work cooperatively with the MACS leadership team and cross-functional MACS partners to drive overall success and performance of the building.

Requirements

• Bachelor's degree in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline with at least 2 years of relevant experience in a process development lab, pilot plant/manufacturing facility, or other operations environment. OR 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.
• 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 (S&E) regulations.
• Experience operating/maintaining manufacturing scale, pilot scale, and/or lab scale equipment.
• Effective communication skills and a collaborative mindset.
• Experience in conflict resolution and root cause analyses.
• Ability to build effective work relationships with a varied workforce.
• Adaptable to a dynamic production environment.
• Relevant experience in a process development lab or pilot plant/manufacturing facility.
• Working in an environment with Automation Systems (DeltaV, PLC, etc.).

Nice To Haves

• GMP facility design, equipment start-up and/or qualification.
• Small molecule drug substance and/or biologics process development.
• Supporting compliance investigations and change management.
• Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA).
• Potent Compound processing and containment systems (e.g., isolators).
• Interacting with process utility systems associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc.
• 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 to meet MACS objectives and customer requirements.
• Prioritize and assign daily activities for the operations staff.
• Implement process improvement actions to meet S&E (Safety & Environmental) and GMP requirements.
• Ensure facility readiness for API (Active Pharmaceutical Ingredient) processing.
• Contribute to equipment and facility design, system commissioning/qualification, and other critical activity workstreams to enable facility startup.
• Foster a culture of collaboration, learning and innovation.
• Coordinate maintenance activities around processing activities to support reliable facility operation.
• Potentially support other new and/or existing facilities across the Small Molecule Process Research & Development (SM PR&D) network.
• Provide direct support to other areas such as: Small Scale Organics Pilot Plant (SSO) and Prep Lab Area.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

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