MACS Sr. Process Supervisor
$117k - $184.2kMSD Malaysia
Job Overview The Modality Agnostic Chemistry Scaleup (MACS) group within the Chemical Engineering Research & Development (CERD) Department seeks a highly motivated Process Supervisor to support pilot plant operations and engineering fundamentals. The role reports to the Associate Director, MACS Operations and is based at the Rahway, NJ facility. Responsibilities Senior Specialist – Process Supervisor will serve as an operations team member for the new potent, multi-modality drug substance development and GMP clinical manufacturing plant currently under construction. The supervisor will supervise daily production activities, ensure compliance with Safety, GMP Quality, and Environmental requirements, prioritize and assign daily activities for the operations staff, implement process improvement actions, and support facility readiness for API processing. The role also collaborates with MACS leadership and cross‑functional partners to drive overall success and performance of the building. Additional Supported Areas Small Scale Organics Pilot Plant (SSO) – Good Manufacturing Practice (GMP) manufacturing facility serving as an internal node for small molecule drug substance clinical manufacture and first pilot of commercial small molecule processes. Prep Lab Area – Generates data that contributes to process definition and provides Phase I/IIa clinical material when needed. Education and Minimum Experience • Bachelor’s degree in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or 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 High school diploma with at least 10 years of relevant experience in a process development lab or pilot plant/manufacturing facility. Required Experience and Skills 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 (cGMPs), Good Documentation Practices (GDPs), and Safety & Environmental (S&E) 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. Adaptable to a dynamic production environment. Relevant experience in a process development lab or pilot plant/manufacturing facility. Ability to rotate between 1st and 2nd shift on a weekly basis. 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 (DeltaV, PLC, etc.). Preferred Experience and Skills 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 process utility system associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc. Experience with quality systems notifications, Root Cause Analysis (RCA), Corrective Action Preventative Action (CAPA), quality change controls, and/or safety Management of Change (MOC). Salary and Benefits The salary range for this role is $117,000.00 – $184,200.00 . The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities to 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. #J-18808-Ljbffr
$117k - $184.2k
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