Cytovale
At Cytovale, we’re focused on more rapid and insightful ways to diagnose fast-moving and immune-mediated diseases.
medical device
51 - 200
Laboratory Manager, Engineering & Compliance
August 26
🏢 In-office - San Francisco
Cytovale
At Cytovale, we’re focused on more rapid and insightful ways to diagnose fast-moving and immune-mediated diseases.
medical device
51 - 200
Description
• Ensure lab Research Associates comply with all relevant safety, FDA regulations, and ISO standards • Provide effective coordination with cross-functional stakeholders • Act as the central point of contact between the laboratory and cross-functional departments • Guide a team of approximately 5 Research Associates in the Engineering group • Develop and update test protocols, SOPs, and Work Instructions in compliance with Cytovale’s QMS • Support regular laboratory audits to ensure compliance with both internal and external standards
Requirements
• Bachelor’s Degree in relevant science or engineering discipline (e.g., biology, biomedical engineering) • 5+ years experience in a regulated lab setting • Supervisory experience in a GxP (BSL-2 minimum) laboratory environment • Hands-on GxP Laboratory experience required • Experience executing design verification and validation activities • Diligent record-keeping in lab notebook and computer systems • Experience with electromechanical systems preferred • Experience with complaint handling preferred • Demonstrated abilities with troubleshooting complex laboratory equipment and root cause analysis • Knowledge of 21 CFR 820.30, ISO 14971, 8 CCR 3203, 8 CCR 5193, & 29 USC 654 preferred
Benefits
• Generous base salary • Yearly cash bonus based on corporate and individual goal attainment • Equity stake in the organization
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