Senior Specialist -Engineering

Job Description

The Modality Agnostic Chemistry Scaleup (MACS) Operations team within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast‑paced environment with a high degree of technical and project management responsibility. This Senior Specialist position will report to a MACS Facility Lead (Associate Director, Engineering) as part of the core engineering team supporting the MACS facility.

The incumbent will hold a process engineering role, serving as both an individual contributor and a technical mentor to support the MACS facility – a new, potent, multi‑modality (small molecule, macrocyclic peptides, bioconjugates) drug substance development and GMP clinical manufacturing pilot plant currently under construction in Rahway, New Jersey. The engineer will demonstrate a mindset of safety and quality compliance, including following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDocP).

As the MACS facility is currently under construction, the selected candidate will contribute to equipment and facility design, system commissioning/qualification, and other critical activity work streams to enable facility startup and subsequent batch processing. The candidate will be a key part of a team of process/facility engineers and foster a culture of collaboration, learning, and innovation. They will collaborate closely with development engineers, chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, and ultimately to enable flexibility and speed of the Company's pipeline.

This role may support facility operations, process development activities, compliance investigations/change management, author GMP documentation, and manage/lead engineers in any of the Company's enabling facilities.

• Leverage depth and breadth of scientific, technical, and operational experience to support facility startup and long‑term operations.
• Author and review documentation required for facility startup, non‑GMP and GMP operations.
• Perform Cleaning and Containment Verification (CCV) for the suite of specialized equipment for MACS potent processing – including managing the CCV strategy, providing shop‑floor support for testing, and working with key partners in Analytical, Quality, and Safety for testing.
• Develop and implement Industrial Hygiene strategy and controls – in partnership with Safety & Environmental.
• Provide mentorship and oversight for the extended team to progress facility needs.

• Small Scale Organics Pilot Plant (SSO):
  The SSO is a GMP manufacturing facility in the Process Research and Development (PR&D) organization, serving as a node for small‑molecule drug substance clinical manufacture and furthering internal experience with GMP scale‑up, new technologies, and seamless tech transfer.
• Prep Lab Area:
  The Prep Lab generates data that contributes to process definition and provides Phase I/IIa clinical material when needed. It is upgrading to support pipeline programs such as Antibody Drug Conjugates (ADCs), Peptide Drug Conjugates (PDCs), and other cross‑modality compounds requiring flexible potent compound processing.

• Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences, or related scientific field with a minimum of 5 years relevant experience;
• Master’s degree with 4 years of relevant experience; or
• PhD with 1 year of relevant experience.

• Experience in GMP clinical supply facility.
• 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.
• Familiarity with U.S. and EU GMP and Safety compliance regulations.
• Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA).
• Ability to convert new drug substance process needs into executable steps and procedures to enable acquisition.