Associate Specialist Operations, Chemical Engineering Research & Development

Job Description

MACS (Modality Agnostic Chemistry Scaleup) Operations group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast‑paced environment that provides operations experience and a strong understanding of engineering fundamentals.

The MACS Operations Specialist position will report to the Associate Director, Engineering and will be a member of the MACS Operations team at the Rahway, NJ facility.

The Operations Specialist will:

• Serve as an operations team member supporting the MACS Center, a new powerful, multi‑modality (small‑molecule, macrocyclic peptides, bioconjugates) drug substance development and GMP clinical manufacturing plant under construction.
• Contribute to equipment and facility design, equipment or material testing, and system commissioning/qualification during the startup and testing phase.
• Key contributor to the Operational Readiness program, establishing procedures, documentation, and training necessary to operate and maintain a new business area after completion of the facility startup.
• Collaborate closely with development engineers, chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies.
• Once the MACS Center is operational, support equipment setups, raw material sampling and subdivisions, solution preparations, batch processing planning and execution at pilot scale, process knowledge capture, and troubleshooting equipment to advance process development, aid technology development, and supply API for clinical use and drug product development.
• Handle a variety of reagents, solvents, and active pharmaceutical ingredients during wet chemistry operations (chemical reactions, extractions, distillations, crystallizations, filtration, drying, etc.) and dry powder processing (e.g., dry milling).

• Small Scale Organics Pilot Plant (SSO):
  The SSO is a GMP manufacturing facility in PR&D. It serves as PR&D’s internal node for small‑molecule drug substance clinical manufacture and as a preferred site for the first pilot of commercial small‑molecule processes, enabling critical internal experience with scale‑up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, and training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites.
• Prep Lab Area:
  The Prep Lab generates data that contributes to process definition and provides Phase I/IIa clinical material when needed. It includes a cleanroom suite for GMP small‑scale manufacturing of potent and multi‑modality clinical materials and is being upgraded to support pipeline programs such as ADCs, PDCs, and other cross‑modality compounds that require a flexible potent compound processing space.

• Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field plus one (1) year relevant work experience.
• OR – Associate in Science, Associate in Applied Science (ideally in Process Technology), or Associate degree in a relevant technical field of study plus at least six (6) years experience.
• OR – High School Diploma/GED plus at least eight (8) years of relevant experience in Pharmaceutical, Chemical, Petrochemical or Food Processing/Manufacturing.

• Experience working on 8‑hour shifts; current operations team works a common shift, with future rotation between 1st and 2nd shift on alternating weeks as the MACS Center comes online and reaches full operations.
• Onsite presence required.