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

The Operations Specialist supports the Modality Agnostic Chemistry Scaleup (MACS) Center during its construction, startup, and operation phases. Key duties include:

• Contributing to equipment and facility design, testing, and commissioning/qualification.
• Participating in the Operational Readiness program to establish procedures, documentation, and training for the new business area.
• Collaborating closely with development engineers, chemists, and compliance representatives to ensure the quality and safe delivery of clinical supplies.
• Assisting with equipment setups, raw material sampling, solution preparations, batch processing planning and execution at pilot scale.
• Capturing process knowledge and troubleshooting equipment to advance process development and supply Active Pharmaceutical Ingredient (API) for clinical use.

• Small Scale Organics Pilot Plant (SSO) – works within the PR&D organization to support GMP manufacturing of small molecule drug substances and pilot scale technology development.
• Prep Lab Area – generates data for process definition and produces Phase I/IIa clinical material; includes a cleanroom suite for GMP small‑scale manufacturing of potent and multi‑modality clinical materials.

• Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a related scientific field plus one year of relevant work experience.
• Associate’s degree in Process Technology or a relevant technical field plus at least six years of relevant experience.
• High School Diploma/GED plus at least eight years of relevant experience in pharmaceutical or related manufacturing.

• Working 8‑hour shifts, with onsite presence five days a week and potential overtime as business needs arise.
• Effective interpersonal and communication skills, both verbal and written.
• Excellent organizational skills and the ability to multi‑task.
• Strong mechanical aptitude and independent problem‑solving mindset.
• 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 and/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 with Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA).
• Experience with potent compound processing and containment systems (e.g., isolators) or clean‑room facilities.
• Experience overseeing process utility systems in a large drug substance pilot plant (e.g., WFI, vacuums, chillers).
• Experience in environments with automation systems (DeltaV, PLC, etc.).
• Operations experience in a pilot plant or manufacturing environment.
• Familiarity with cGMP administration, Good Documentation Practices (GDP), and S&E regulations.
• Lean Six Sigma Training / Certification.

We offer a comprehensive package of benefits including medical, dental, vision, and other insurance for the employee and family, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days. Detailed information is available after application review.

The salary range for this role is $71,900.00 – $. The specific salary will be based on education, experience, qualifications, and other factors. Successful candidates may be eligible for annual bonus and long‑term incentive plans.

As an Equal Employment Opportunity Employer, we provide equal opportunities for all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, see the EEOC Know Your Rights and EEOC GINA supplement resources available through federal guidance.