Manager, Operations (Onsite)
Merck
Summary
The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey. This team works with non-sterile formulations, typically oral solid dosage though also including spray dried intermediates, liquid suspension/bottle fills, and autoinjector assembly. This team produces clinical and development drug product batches in a GMP piloting facility supporting our research division and on-site project development teams.
Job description
The Oral Solids Dosage (Non-Sterile) team at the FLEx Center in Rahway is looking for an evening shift supervisor to focus on spray drying production runs as well as cleaning and turnaround activities. This will be a new shift. The successful candidate would stand-up and manage a team of 3 or more operations staff. This includes daily assignments, helping troubleshoot issues, improving the facility through process improvement, learning the equipment, and participating in production activities. We are looking for a candidate with previous spray drying experience who is willing to work alongside operations staff to execute on activities each evening. The evening shift will be mostly cleaning and turnaround (assembly/disassembly) so a good mechanical understanding of process equipment will be required. While most batch production will occur on days, on occasion spray drying runs may require continuing into the evening, and the 2nd shift team would all be trained for execution on this production activity. Strong experience in working with Good Documentation Practices (GDP) is required, as the successful candidate will be a reviewer and approver. Regular feedback and coaching is a part of this position as it will be based on the shop-floor. Experience with electronic batch records and documentation is a plus.
Key Responsibilities
- Learns equipment well enough to become a trainer.
- Develops daily plan and assignments.
- Facility alarm first responder and early troubleshooting.
- Coordinates with Mechanical team for area/equipment availability.
- Post-reviews batch records and cleaning records for GDP completion.
- Reviews logs.
- Manages cleaning planning, documentation, turnaround, samples, ARL/VRL.
- Coordinates water sampling, cleaning, PPE requests.
- Coordinates equipment moving.
- Direct manager of operating staff including development of team.
- People management, issue resolution, and coaching.
- Facilitates area access requests.
- Functional focused management.
- Manages process locks.
- Hot work/declassification permit management with mechanical team.
- Follows the daily operations.
Requirements
- At least 3 years of experience managing a team in a pharmaceutical or regulated (e.g. food) GMP production area
- High school diploma + At least 7 years of experience in pharmaceutical production, OR Bachelors Degree in a relevant field, or equivalent + 4 years of experience in pharmaceutical production
Preferred Requirements
- Oral solid dosage experience
- Spray drying experience
- Experience managing documentation
- Assignments of team
- Development and training of team
- Issue resolution and coaching
- Partnership with safety and mechanical team members
Requirements
- At least 3 years of experience managing a team in a pharmaceutical or regulated (e.g. food) GMP production area
- High school diploma + At least 7 years of experience in pharmaceutical production, OR Bachelors Degree in a relevant field, or equivalent + 4 years of experience in pharmaceutical production
- Strong experience in working with Good Documentation Practices (GDP)
- Good mechanical understanding of process equipment
- Previous spray drying experience
- Batch Production Records
- Leadership
- Operational Activities
- People Leadership
- Pharmaceutical Manufacturing
- Process Equipment
- Production Scheduling
- Shop Floor Management
- Solid Dosage Forms
- Spray Drying
Benefits
- Medical, Dental & Vision
- Retirement benefits
- 401(k)
- Paid holidays
- Vacation
- Compassionate and 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.