Production Laboratory Supervisor

Danaher • Sacramento, CA

31d • Onsite

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you'll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world's most complex health challenges. Together, we bring MORE change to the world. Learn about the Danaher Business System which makes everything possible. The Production Laboratory Supervisor is responsible for the effective and efficient management of their assigned area's resources including all personnel, equipment and tools utilized for manufacturing reagents used in finished products. This position reports to the Manager, Reagent Manufacturing and is part of the Production Team located in Lodi, CA and will be an on-site role. The schedule for this role is Monday- Friday from 3pm- 11:30pm.

Requirements

• High school degree with 8+ years of experience or bachelor's degree with 5+ years of experience OR Master's degree with 3+ years of experience
• Thorough knowledge of GDP and cGMP regulations.
• Consistent track record in method, equipment, and system validation.
• Experience in a high pace Laboratory operation working with oligos, dyes, enzymes liquid nitrogen and lyophilization.
• Experience providing leadership.

Nice To Haves

• Working knowledge of SAP, LIMS, MES, BRAM systems.
• Experience with Spectrophotometry, PCR, Dialysis, TFF, pH, Density, and Conductivity testing.
• Experience with regulatory requirements and audit readiness/inspections.

Responsibilities

• Manage the Reagent Manufacturing department daily work activities including Team schedule, ensuring training, general guidance of direct reports and across functional groups
• Support development of analytical methods. Work in conjunction with other departments to develop, qualify, and transfer analytical methods as applicable.
• Ensure maintenance of equipment - qualification, calibration and maintenance.
• Draft, review, and approve Standard Operating Procedures (SOP), sampling plans, specifications, protocols and reports related to product/processes, equipment, method, validation. This includes deviation investigation and reporting.
• Identify and implement improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes.
• Lead investigations for failures during testing; perform troubleshooting, process development or improvement activities.

Benefits

• Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
• We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees