Formulation Production Manager

As a Production Manager, you will be responsible for leading the Formulation manufacturing department to ensure the safe, reliable, and efficient production of high-quality products in accordance with production schedules, quality standards, and regulatory requirements. This position provides leadership for daily manufacturing operations while driving operational excellence, continuous improvement, and employee development.

Working closely with Planning, Quality Control, Quality Assurance, Manufacturing Engineering, Supply Chain, Marketing, and Research & Development, the Production Manager ensures production objectives are achieved while maintaining compliance with applicable GMP requirements, company policies, and safety standards.

The Production Manager is accountable for production planning and execution, allocation of personnel and equipment resources, schedule adherence, productivity, product quality, and cost performance. This role leads and develops manufacturing personnel, promotes a culture of safety and quality, resolves operational issues, and drives continuous process improvements to meet customer demand and business objectives.

Location: This position must be based in Irvine, California
and requires the employee to be located within commuting distance of the office.

How You'll Make An Impact:

• Lead all production activities required to formulate diagnostic reagents for transfer to the Filling department, ensuring products are manufactured safely, efficiently, and in accordance with production schedules, quality standards, and regulatory requirements.
• Ensure consistent and reliable formulation of diagnostic reagents by maintaining batch integrity, process consistency, and manufacturing readiness while supporting uninterrupted downstream filling and finished product production.
• Manage and develop a team of Production Supervisors responsible for direct labor personnel, including assemblers, technicians, and chemists, by providing leadership, coaching, performance management, and employee development.
• Ensure compliance with applicable Good Manufacturing Practices (GMP), quality systems, company policies, and Environmental Health & Safety (EHS) requirements.
• Develop, implement, and continuously improve labor standards, manufacturing processes, and production workflows for both new and existing products.
• Develop, revise, and enforce Standard Operating Procedures (SOPs), work instructions, and manufacturing best practices to support safe, consistent, and compliant operations.
• Plan, coordinate, and prioritize manufacturing activities to achieve production schedules, inventory objectives, and successful new product introductions.
• Partner with Planning, Supply Chain, Quality Assurance, Quality Control, Manufacturing Engineering, and R&D to optimize production schedules, resolve manufacturing issues, and improve operational performance.
• Prepare and manage departmental operating budgets, headcount plans, salary planning, and capacity forecasts while maintaining cost objectives.
• Monitor production metrics and operating reports to identify trends, resolve manufacturing and equipment issues, and minimize production delays and operating costs.
• Lead continuous improvement initiatives utilizing Lean Manufacturing and Six Sigma methodologies to improve productivity, quality, safety, and operational efficiency.
• Serve as a change leader by driving cross-functional improvement projects and supporting strategic operational initiatives.
• Improve manufacturing cost structure through increased labor productivity, process optimization, waste reduction, and efficient utilization of personnel and equipment.
• Partner with Quality Assurance to investigate manufacturing deviations, support root cause analysis, implement corrective and preventive actions (CAPAs), and participate in change control activities as appropriate.
• Recommend and support capital equipment investments and facility improvements that increase manufacturing capacity, quality, efficiency, and reliability.
• Establish, monitor, and report departmental Key Performance Indicators (KPIs), including schedule attainment, labor efficiency, productivity, yield, quality, and on-time delivery.
• Support internal audits, customer audits, and regulatory inspections by ensuring manufacturing operations remain inspection-ready.
• Foster a culture of teamwork, accountability, continuous improvement, quality, and safety while addressing employee relations issues in partnership with Human Resources.
• Support…