Formulation Production Manager

Bio-Rad Laboratories · Irvine

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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 technology transfer, process validation, and manufacturing readiness activities for new product launches and process improvements.

Perform other duties and special projects as assigned.

What You Bring:

Bachelor’s degree or equivalent in Business, Mechanical, Electrical, Industrial or related field.

8+ years 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 experiences. 

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.

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