Operations Lead (Shop Floor Supervisor)
Merck
Summary
The Modality Agnostic Chemistry Scaleup (MACS) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides pilot plant operations experience and a strong understanding of engineering fundamentals. The Process Supervisor position will report to the Associate Director, MACS Operations and will be a member of the MACS Operations Team at the Rahway, NJ facility.
Job description
Responsibilities
- Serve as an operations team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center, a new potent, multi-modality drug substance development and GMP clinical manufacturing plant.
- Contribute to equipment and facility design, system commissioning/qualification, and other critical activity workstreams to enable facility startup.
- Supervise and participate in daily production activities while ensuring compliance with Safety, GMP Quality, and Environmental requirements.
- Prioritize and assign daily activities for the operations staff.
- Implement process improvement actions to meet Safety & Environmental (S&E) and GMP requirements.
- Ensure facility readiness for API processing and share accountability for the facility's performance.
- Work cooperatively with the MACS leadership team and cross-functional partners to drive overall success and performance of the building.
- Potentially support other facilities such as the Small Scale Organics Pilot Plant (SSO) and Prep Lab Area.
Education Minimum Requirement
Bachelor's degree in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline with at least 2 years of relevant experience in a process development lab, pilot plant/manufacturing facility, or other operations environment. OR High school diploma with at least 6 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.
- Supervising a team of shop floor personnel in an operations environment.
- Understanding of and experience with cGMPs, GDPs, and 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 varied workforce.
- Adaptable to a dynamic production environment.
- Relevant experience in a process development lab or pilot plant/manufacturing facility.
- Must be able to rotate between 1st and 2nd shift on a weekly basis.
- Desire and willingness to learn, contribute and lead.
- Coordinating maintenance activities around processing activities to support reliable facility operation.
- Working in an environment with Automation Systems (DeltaV, PLC, etc.).
Desired Experience and Skills
- GMP facility design, equipment start-up and/or qualification.
- Small molecule drug substance and/or biologics process development.
- Supporting compliance investigations and change management.
- Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA).
- Potent compound processing and containment systems (e.g., isolators).
- Interacting with process utility systems associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc.
- Quality systems notifications, Root Cause Analysis (RCA), Corrective Action Preventative Action (CAPA), quality change controls, and/or safety Management of Change (MOC).
Requirements
- Bachelor's degree in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline with at least 2 years of relevant experience in a process development lab, pilot plant/manufacturing facility, or other operations environment; OR High school diploma with at least 6 years of relevant experience
- Mechanical aptitude and familiarity with chemical process development and process equipment
- Supervising a team of shop floor personnel in an operations environment
- Understanding of and experience with cGMPs, GDPs, and 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 varied workforce
- Adaptable to a dynamic production environment
- Relevant experience in a process development lab or pilot plant/manufacturing facility
- Must be able to rotate between 1st and 2nd shift on a weekly basis
- Desire and willingness to learn, contribute and lead
- Coordinating maintenance activities around processing activities to support reliable facility operation
- Working in an environment with Automation Systems (DeltaV, PLC, etc.)
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Holidays
- Vacation
- Compassionate Leave
- Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.