Formulation Production Manager

Location: Irvine, California (on-site; must be within commuting distance).

About the role

Lead the Formulation manufacturing department to ensure safe, reliable, and efficient production of high-quality diagnostic reagents in accordance with production schedules, quality standards, and regulatory requirements. Drive operational excellence, continuous improvement, and employee development while collaborating with Planning, Quality Control, Quality Assurance, Manufacturing Engineering, Supply Chain, Marketing, and Research & Development. Accountable for production planning, resource allocation, schedule adherence, productivity, product quality, and cost performance.

Responsibilities

• 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 technology transfer, process validation, and manufacturing readiness activities for new product launches and process improvements.
• Perform other duties and special projects as assigned.

Requirements

• Bachelor’s degree or equivalent in Business, Mechanical, Electrical, Industrial, or related field.
• 8+ years of manufacturing production experience, preferably in a regulated environment, or equivalent combination of education and experience.
• Proven leadership skills in a Production or Manufacturing environment.
• Demonstrated change management experience.
• 5–8 years of supervisory/management experience, preferably with demonstrated coaching and mentoring experience.
• Familiarity with SAP and other manufacturing materials systems.
• Effective communication skills.
• PC skills (Excel, Word, PowerPoint, database software, internet software, manufacturing software).
• Experience with chemical, instrument, or facility production processes and process equipment.

Benefits

• Competitive medical plans for you and your family, including free HSA funds.
• New fertility offering with stipend.
• Group life and disability insurance.
• Paid parental leave.
• 401k with profit sharing.
• Employee stock purchase program.
• Upgraded and streamlined mental health platform.
• Extensive learning and development opportunities, education benefits, and student debt relief program.
• Pet insurance.
• Wellness challenges and support.
• Paid time off.
• Employee Resource Groups (ERGs).

Pay

Estimated base salary range: $121,200 – $166,700. Actual compensation will be based on geographic location, experience, knowledge, skills, abilities, and other job-related factors. This position is also eligible for a variable annual bonus dependent on individual and company performance.