Production Manager, Compounding Operations

Remedy • Houston, TX

1d

About The Position

The Production Manager, Compounding Operations, oversees daily production activities across sterile and non-sterile compounding operations. The role ensures efficient workflows, accurate batch scheduling, consistent production output, and compliance with quality and regulatory requirements. Working closely with pharmacy leadership, compounding pharmacists, technicians, and Quality Assurance, the manager optimizes production capacity, streamlines processes, and supports growing patient demand. This is a hands-on leadership role focused on operational efficiency, team performance, and continuous improvement across multiple compounding lines.

The position plans and coordinates production schedules, staffing, equipment, and materials; leads compounding production teams; supports training and performance management; and partners with Quality Assurance and licensed pharmacy leadership to maintain compliant, safe operations. It also develops performance measures, improves production processes, supports equipment and capability implementation, and helps build scalable systems as operations grow.

Requirements

• Bachelor's degree in Operations Management, Pharmaceutical Sciences, Engineering, Chemistry, or a related field, or equivalent relevant experience.
• At least 5 years of experience in pharmaceutical manufacturing, compounding pharmacy operations, or a similarly regulated production environment.
• At least 2 years of experience managing production teams, supervising manufacturing operations, or leading complex production workflows.
• Experience with batch scheduling, production planning, resource allocation, and workflow optimization.
• Working knowledge of pharmaceutical production processes, quality systems, SOPs, and GMP principles.
• Familiarity with USP <795>, <797>, and <800> requirements and their application to compounding operations.
• Demonstrated ability to manage production schedules, meet operational targets, and improve efficiency in a regulated environment.
• Experience partnering with Quality Assurance and technical teams to resolve production issues and maintain compliance.
• Strong leadership, organizational, analytical, and problem-solving skills.
• Ability to work independently, prioritize competing demands, and thrive in a fast-paced, growing operation.
• Ability to stand, walk, and move throughout pharmacy production areas for extended periods.
• Ability to lift up to 35 lbs.
• Ability to work in controlled production and cleanroom environments, including appropriate gowning, PPE, and facility safety protocols.
• Ability to follow cleanroom, hygiene, and contamination-control requirements and work with appropriate engineering and PPE controls where pharmaceutical ingredients and hazardous drugs may be present.
• Must pass fit-testing for respiratory protection where applicable.

Nice To Haves

• Direct experience managing sterile and non-sterile compounding operations in a 503A pharmacy or 503B outsourcing facility.
• Experience in an FDA-registered pharmaceutical manufacturing or outsourcing facility operating under cGMP.
• Familiarity with specialized pharmaceutical manufacturing equipment, including Korsch tablet presses, hot-melt extrusion (HME), pharmaceutical 3D printing, LMX mixers, and capsule fillers.
• Experience scaling production operations, implementing new equipment, or launching additional production lines.
• Knowledge of Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.
• Experience with electronic batch records, pharmacy management systems, manufacturing execution systems (MES), or production reporting tools.
• Experience supporting regulatory inspections, deviation investigations, and CAPA initiatives.

Responsibilities

• Oversee daily production across sterile and non-sterile compounding lines to ensure safe, efficient, and timely execution.
• Develop and manage batch production schedules based on prescription demand, staffing, equipment capacity, and material availability.
• Coordinate production priorities and workflows to meet operational targets and turnaround times.
• Monitor throughput, batch completion, yields, and operational bottlenecks; optimize equipment utilization, labor allocation, and other production resources.
• Partner with pharmacy leadership to forecast production needs and develop capacity plans as volume increases.
• Ensure production follows approved master formulation records, batch instructions, and standard operating procedures.
• Coordinate equipment readiness, preventative maintenance, and production downtime with appropriate teams.
• Provide day-to-day leadership and oversight of sterile and non-sterile compounding production teams.
• Manage staffing schedules, workload distribution, and production priorities; establish performance expectations and monitor productivity, quality, and procedural adherence.
• Support onboarding, training, competency development, performance management, and team expansion.
• Promote accountability, collaboration, patient safety, and continuous improvement.
• Partner with Quality Assurance and licensed pharmacy leadership to support compliance with USP <795>, <797>, and <800>, state Board of Pharmacy regulations, and facility SOPs.
• Ensure production documentation, batch records, equipment logs, and related operational records are accurate and complete.
• Monitor adherence to cleaning, sanitation, environmental control, and safety procedures.
• Identify and promptly escalate production deviations, quality concerns, and out-of-specification results.
• Support investigations, root cause analysis, and corrective and preventive actions related to production processes.
• Assist with internal audits, regulatory inspections, and ongoing inspection readiness.
• Coordinate required quality checks and approvals before product release while maintaining appropriate separation between production responsibilities and independent quality oversight.
• Identify and implement improvements to throughput, downtime, waste, workflows, scheduling practices, and operational procedures.
• Establish and track key performance indicators, including batch completion rates, turnaround times, schedule adherence, labor utilization, and production efficiency.
• Analyze production performance and recommend ways to increase capacity without compromising quality.
• Partner with pharmacy leadership, Quality Assurance, and technical teams to resolve operational challenges.
• Support implementation of new compounding equipment, technologies, and production capabilities.
• Help develop scalable production systems and processes for continued growth across sterile and non-sterile operations.

Benefits

• Robust and affordable medical, dental, and vision plan options.
• Vacation time off policy, with up to 10 vacation days accrued in the first year; vacation time begins accruing immediately.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager