MACS Sr. Process Supervisor

Job Description

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 environment 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.

As the process supervisor at the Senior Specialist level, you will serve as an operations team member supporting the MACS Center for a new potent, multi‑modality (small molecule, macrocyclic peptides, bioconjugates) drug substance development and GMP clinical manufacturing plant currently under construction. Your key responsibilities include:

• Supporting equipment and facility design, system commissioning/qualification, and critical activity work streams to enable facility startup.
• Supervising and participating in daily production activities while ensuring compliance with safety, GMP quality, and environmental requirements.
• Prioritizing and assigning daily activities for operations staff.
• Implementing process improvement actions to meet safety and environmental and GMP requirements.
• Ensuring facility readiness for API processing and sharing accountability for facility performance.
• Collaborating with MACS leadership and cross‑functional partners to drive overall success and performance.

In addition to supporting current capital projects, the Senior Specialist may provide direct support to the following areas:

• Small Scale Organics Pilot Plant (SSO) – a GMP manufacturing facility in the Process Research and Development (PR&D) organization that serves as an internal node for small‑molecule drug substance clinical manufacture and as a preferred site for pilot of commercial small‑molecule processes.
• Prep Lab Area – a facility that generates data for process definition and provides Phase I/IIa clinical material, with ongoing upgrades to support pipeline programs such as ADCs and PDCs.

• Bachelor’s degree in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or a related engineering/scientific discipline with at least 5 years of relevant experience in a process development lab, pilot plant/manufacturing facility, or other operations environment.
• OR at least 10 years of relevant experience with a high school diploma 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, Good Documentation Practices, and safety and environmental 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 diverse workforce.
• Adaptability to a dynamic production environment.
• Relevant experience in a process development lab or pilot plant/manufacturing facility.
• Ability to work both 1st and 2nd shift on a weekly basis during equipment qualification and operations.
• Desire and willingness to learn, contribute, and lead.
• Experience coordinating maintenance activities around processing activities to support reliable facility operation.
• Experience working in an environment with automation systems (Delta
  
  V, PLC, etc.).

• Experience with GMP facility design, equipment start‑up, and/or qualification.
• Experience with small‑molecule drug substance and/or biologics process development.
• Experience supporting compliance investigations and change management.
• Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA).
• Experience with potent compound processing and containment systems (e.g., isolators).
• Experience interacting with…