Manager, Operations (Onsite)

Merck • Rahway, NJ

1d • $96,200 - $151,400 • Onsite

About The Position

The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, is a multi-modality drug product development and clinical manufacturing facility supporting research and on-site project development teams. Its Oral Solids Dosage (Non-Sterile) team works with non-sterile formulations, primarily oral solid dosage, and also spray-dried intermediates, liquid suspensions and bottle fills, and autoinjector assembly.

The role will establish and manage a new evening-shift team of three or more operations staff, focusing primarily on spray-drying production runs, cleaning, and equipment turnaround. The manager will develop daily assignments, troubleshoot operational issues, improve processes, learn and train others on equipment, and participate in shop-floor production activities. The evening shift will mostly handle cleaning and turnaround, including equipment assembly and disassembly; occasionally, spray-drying production may continue into the evening, and the team will be trained to perform that work.

The successful candidate will work alongside operations staff, bring spray-drying experience and a strong mechanical understanding of process equipment, and have substantial experience with Good Documentation Practices (GDP). The position includes reviewing and approving documentation, as well as regular staff feedback, coaching, and development. Experience with electronic batch records and documentation is a plus.

Requirements

• At least 3 years of experience managing a team in a pharmaceutical or other regulated GMP production area, such as food production.
• High school diploma and at least 7 years of experience in pharmaceutical production, or a bachelor's degree in a relevant field (or equivalent) and at least 4 years of experience in pharmaceutical production.
• Strong experience with Good Documentation Practices (GDP), including reviewing and approving documentation.
• Previous spray-drying experience.
• Strong mechanical understanding of process equipment.

Nice To Haves

• Oral solid dosage experience.
• Experience managing documentation, including electronic batch records.
• Experience assigning work and developing and training a team.
• Experience with issue resolution and coaching.
• Experience partnering with safety and mechanical team members.

Responsibilities

• Learn equipment thoroughly enough to become a trainer.
• Develop the daily plan and assign work.
• Serve as the first responder to facility alarms and perform initial troubleshooting.
• Coordinate with the Mechanical team to ensure area and equipment availability.
• Post-review batch and cleaning records for GDP completion and review logs.
• Manage cleaning plans, documentation, turnaround, samples, and ARL/VRL.
• Coordinate water sampling, cleaning, and PPE requests.
• Coordinate equipment moves.
• Directly manage operating staff, including team development, issue resolution, and coaching.
• Facilitate area access requests and provide function-focused management.
• Manage process locks and hot-work/declassification permits in coordination with the Mechanical team.
• Follow daily operations and participate in production activities.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays.
• Vacation.
• Compassionate and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager