Pharmaceutical cGMP Production Manager

Job Title: Production Manager

Reports to: Site Manager / Chief Operating Officer

Hours: 8:30am-5:00pm

Full Time or Part Time: Full-Time

The Production Manager will oversee the daily manufacturing operations for our compounded pharmaceutical production lines. This role requires a leader who can thrive in a highly dynamic production environment while maintaining unyielding adherence to cGMP standards and FDA 503B regulations. You will bridge the gap between traditional compounding flexibility and industrial-scale pharmaceutical compliance, ensuring that production targets are met without ever compromising quality.

You will work closely with the Quality Unit to build a culture of continuous improvement, proactive risk management, and exact documentation.

• 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.

• Partner with Quality on the revision, implementation, and continuous improvement of master batch records and manufacturing instructions.

• Collaborate with the Chief Quality Officer (CQO) and Quality Assurance team to investigate deviations, implement Corrective and Preventive Actions (CAPAs), and resolve non‑conformances.

• Lead or support manufacturing investigations related to deviations, atypical events, and batch failures, ensuring timely root cause analysis and implementation of effective corrective actions.

• Monitor recurrence trends and implement sustainable process improvements to reduce repeat events.

• Ensure a state of continuous "audit readiness" for federal and state inspection walkthroughs.

• 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.

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.

• Bachelor’s degree in Engineering (Chemical, Mechanical, Industrial), Pharmacy, Life Sciences, or a related field (preferred).

• Minimum of 5–7 years of progressive leadership experience in pharmaceutical manufacturing, specifically within solid…