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 be a member of the MACS Operations team at the Rahway, NJ facility.

The MACS Center is a new, potent, multi‑modality (small molecule, macrocyclic peptides, bioconjugates) drug substance development and GMP clinical manufacturing plant under construction in Rahway, New Jersey. The Operations Specialist will support startup, testing, pilot plant operations, and, if applicable, other facilities across the Small Molecule Process Research & Development (SM PR&D) network.

• Act as an operations team member supporting the MACS Center startup and testing phase and, later, pilot plant operations.
• Contribute to equipment and facility design, equipment or material testing, system commissioning/qualification, and other critical activity work streams to enable facility startup.
• Key contributor to the Operational Readiness program: establish procedures, documentation, and training necessary to operate and maintain the new business area after startup completion.
• Foster a culture of collaboration, learning, and innovation; collaborate closely with development engineers, chemists, compliance representatives, and other team members to ensure quality and safety of clinical supplies.
• Once operational, perform equipment setups, raw material sampling, solution preparations, batch processing planning and execution at pilot scale, capture process knowledge, and troubleshoot equipment to advance process development and supply active pharmaceutical ingredient (API) for clinical use and drug product development.
• Handle reagents, solvents, and active pharmaceutical ingredients during wet chemistry operations (chemical reactions, extractions, distillations, crystallizations, filtration, drying, etc.) and dry powder processing (dry milling).
• Support, as needed, additional areas such as the Small Scale Organics Pilot Plant (SSO) and the Prep Lab for process definition, clinical material generation, and flexible potent compound processing.

• Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences, or related scientific field plus at least one (1) year relevant work experience.
• OR Associate in Science, Associate in Applied Science (ideally in Process Technology), or equivalent Associate degree 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.

• 8‑hour shifts, one common shift across the Operations team with later rotation between 1st and 2nd shift on alternating weeks as the MACS Center comes online.
• Onsite presence required five days a week; occasional overtime may be required.
• Effective interpersonal and communication skills, both verbal and written.
• Excellent organizational skills to multi‑task.
• Strong mechanical aptitude and desire to learn, contribute, and lead.
• Track record of independent problem‑solving and collaborative mindset to interface with cross‑functional teams.
• Proficiency in technical writing and use of word processing, spreadsheet, graphing, and presentation software.

• Experience working in a GMP clinical or manufacturing supply facility.
• Experience with GMP facility design, equipment start‑up, and/or qualification.
• Experience with small molecule drug substance or biologics process development.
• Experience supporting compliance investigations and change management.
• Ability to prepare or leverage Standard Operating Procedures (SOP) and cGMP documents.
• Experience operating/maintaining pilot‑scale or prep‑lab‑scale equipment.
• Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA).
• Experience with potent compound…