Operations Supervisor (2nd shift) - Spray Drying and Oral Solid Dosage Turnaround

Job Description

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.

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.

This position is 100% on-site and evening (2nd) shift. This position will start on days for an initial period of time for training and onboarding before the team flips to evening shift. Occasion weeks on ‘days assignment’ may occur to facilitate training needs throughout a given year.

• 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

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