Pharmaceutical cGMP Production Manager

Responsibilities

• Direct and manage all daily activities on the production floor, including weighing, milling, blending, granulation, compression, and packaging.
• Develop and execute dynamic production schedules to meet shifting market demands.
• Monitor production metrics (yield, downtime, cycle time) and implement corrective measures to ensure efficiency and cost-effectiveness.
• Oversee the management of production equipment and tooling, including inspection, maintenance, and storage.
• Ensure all manufacturing activities strictly comply with 21 CFR Part 210 and 211, as well as specific 503B guidance.
• Ensure accurate, contemporaneous completion and review of executed batch records, logbooks, and shop floor documentation in accordance with GDP and data integrity expectations.
• Promote adherence to data integrity principles across paper and electronic systems.
• Enhance production capabilities by hiring, training, and mentoring a team of production supervisors, leads, and machine operators (production technicians).
• Foster a "Quality First" culture on the floor, encouraging the immediate reporting of near-misses and deviations without fear of retribution.
• Ensure all personnel adhere to strict gowning, personal hygiene, and safety protocols required for handling Active Pharmaceutical Ingredients (APIs) and operating heavy machinery.
• Conduct regular performance evaluations and build training matrices to ensure staff competency on complex equipment (e.g., tablet presses, fluid bed dryers).
• Partner with Facilities and Maintenance Team to ensure all production equipment is calibrated, validated, and subjected to rigorous preventative maintenance schedules.
• Troubleshoot mechanical and processing issues on the floor to minimize downtime.
• Ensure proper line clearance and cleaning validation protocols are strictly followed to prevent cross-contamination between batches.

Qualifications

• The ideal candidate will bring a strong engineering or scientific background alongside progressive leadership experience in pharmaceutical manufacturing, specifically within solid dosage operations.
• Prior experience in an FDA-registered 503B Outsourcing Facility or a strictly regulated cGMP pharmaceutical manufacturing environment is required.
• This role requires an operational leader who can successfully collaborate with Quality Assurance teams, troubleshoot complex processes, and drive continuous improvement on the production floor.