Manager, Operations (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. It works with non-sterile formulations, typically oral solid dosage, as well as spray-dried intermediates, liquid suspensions and bottle fills, and autoinjector assembly. The facility produces clinical and development drug product batches in a GMP piloting environment. The Oral Solids Dosage (Non-Sterile) team is seeking an evening-shift supervisor focused on spray-drying production runs, cleaning, and turnaround activities. The position will establish and manage a team of at least three operations staff, assign daily work, help troubleshoot issues, support process improvement, learn the equipment, and participate in production activities. The successful candidate will have spray-drying experience and be willing to work alongside operations staff to execute evening activities. The shift will primarily handle cleaning and equipment turnaround, including assembly and disassembly, so a strong mechanical understanding of process equipment is required. Although most batch production occurs during the day, spray-drying runs may occasionally continue into the evening, and the second-shift team will be trained to perform this production work. The role requires strong Good Documentation Practices (GDP) experience because the manager will review and approve documentation. Regular feedback and coaching are part of this shop-floor-based position. 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.
- One of the following production experience and education combinations: high school diploma plus at least 7 years of pharmaceutical production experience; or a bachelor's degree in a relevant field, or equivalent, plus 4 years of pharmaceutical production experience.
- Strong experience with Good Documentation Practices (GDP).
- Previous spray-drying experience.
- Mechanical understanding of process equipment.
Nice To Haves
- Oral solid dosage experience.
- Experience managing documentation.
- Experience with electronic batch records and documentation.
- Experience assigning work, developing and training a team, resolving issues, and coaching.
- Experience partnering with safety and mechanical team members.
Responsibilities
- Learn equipment sufficiently to become a trainer.
- Develop daily plans and assign work.
- Serve as the facility alarm first responder and perform early troubleshooting.
- Coordinate with the Mechanical team to ensure area and equipment availability.
- Post-review batch and cleaning records for GDP completion.
- Review logs.
- Manage cleaning planning, documentation, turnaround, samples, and ARL/VRL.
- Coordinate water sampling, cleaning, PPE requests, and equipment movement.
- Directly manage operating staff, including team development.
- Manage people, resolve issues, and coach staff.
- Facilitate area access requests.
- Provide function-focused management and manage process locks.
- Manage hot-work and declassification permits with the Mechanical team.
- Follow daily operations.
Benefits
- Medical, dental, and vision healthcare benefits.
- Other insurance benefits for employees and family.
- Retirement benefits, including a 401(k).
- Paid holidays.
- Vacation.
- Compassionate and sick days.
- Eligibility for an annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
