Pharmaceutical cGMP Production Manager

FARMAKEIO Pharmacy Network • Southlake, TX

1d • Onsite

About The Position

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.

Requirements

• Strong engineering or scientific background.
• 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.
• Operational leader who can successfully collaborate with Quality Assurance teams, troubleshoot complex processes, and drive continuous improvement on the production floor.
• Minimum of 5–7 years of progressive leadership experience in pharmaceutical manufacturing, specifically within solid dosage (tableting) operations.
• Deep technical understanding of the tablet manufacturing process (powder rheology, compression dynamics, tooling specifications, etc.).
• Expert working knowledge of cGMP, OSHA regulations, and standard operating procedures (SOPs) implementation.
• Proven track record of successfully interacting with Quality Assurance teams and participating in FDA audits.
• Strong analytical problem-solving skills (Root Cause Analysis, Fishbone, 5 Whys).
• Ability to stand or walk for extended periods on the manufacturing floor.
• Must be able to wear appropriate personal protective equipment (PPE) and cleanroom gowning for extended shifts.
• Ability to lift up to 50 lbs and work around heavy machinery and loud noises (hearing protection provided when necessary).
• No known allergies to the APIs handled in the facility.

Nice To Haves

• Bachelor’s degree in Engineering (Chemical, Mechanical, Industrial), Pharmacy, Life Sciences, or a related field.
• Experience with Lean Manufacturing or Six Sigma principles.
• Proficiency in ERP systems and electronic Quality Management Systems (eQMS).

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.
• 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.

Benefits

• Healthcare Coverage: Comprehensive health, dental, and vision insurance plans with company-subsidized premiums.
• Peace of Mind: 100% company-paid Short-Term Disability (STD), Long-Term Disability (LTD), and Life Insurance.
• Retirement Savings: A 401(k) plan featuring a 4% company match to help you build for the future.
• Work-Life Balance: Generous Paid Time Off (PTO) so you can relax, recharge, and take care of what matters most.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed