Laboratory Manager, Engineering & Compliance

at  Cytovale Inc

COMPANY DESCRIPTION

Headquartered in San Francisco, CA, Cytovale is a dynamic, late-stage startup focused on developing a faster, more insightful way to diagnose fast-moving and immune-mediated diseases. Cytovale’s IntelliSep test is pioneering a new way of quickly and accurately analyzing white blood cells to stratify a patient’s risk of sepsis. The test simply and clearly determines risk of sepsis using a biomechanical evaluation of white blood cells collected from a standard blood draw, generating results in under 10 minutes. This gives physicians actionable information when they need it most, allowing them to confidently triage suspected sepsis patients quickly and spend more time with those in greatest need. It also helps strained health systems prevent unnecessary treatment, preserve valuable resources, and improve compliance with SEP-1 guidelines.
More information at cytovale.com
The laboratory manager reports to Operations/Facilities leadership. Primary responsibility is to ensure lab Research Associates comply with all relevant safety, FDA regulations and ISO standards, as well as internal test protocols. The second responsibility is to provide effectively coordinate with cross-functional stakeholders to ensure personnel, materials, protocols, and equipment status provide reliable lab utilization. Lab manager must be effective working in a matrix organization at times as a key service provider, as well as an internal customer.

QUALIFICATIONS

• Bachelor’s Degree in relevant science or engineering discipline (e.g., biology, biomedical engineering) and 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 (handling of returned samples, chain of custody, etc.)
• 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.

REQUIREMENTS

• This position is based in South San Francisco, CA; On-site 5 days/week.
• Ability to work in the United States.

• Act as the central point of contact between the laboratory and cross-functional departments including R&D, Quality Assurance, and Technical Service.
• Guide a team of approximately 5 Research Associates in the Engineering group, providing direction and overseeing/contributing to daily GxP laboratory activities for design verification, research, and product development. Personnel reporting is indirect.
• Coordinate laboratory testing with R&D Engineering Leads by aligning project priorities, deadlines, and resources.
• Work closely with the Technical Service team to schedule and oversee timely equipment repairs, upgrades, and maintenance while minimizing Lab service level.
• Develop and update test protocols, SOPs, and Work Instructions in compliance with Cytovale’s QMS and other regulatory standards.
• Ensure laboratory staff, equipment, and records adhere to SOPs and safety regulations, including but not limited to PPE use, chemical and biological material handling, and emergency response procedures.
• Support regular laboratory audits to ensure compliance with both internal and external standards and initiate corrective actions when necessary.
• Investigate non-conformities and implement corrective and preventive actions in coordination with the Quality Assurance team.
• Maintain and organize inventory of equipment, chemicals, and other materials needed for daily operations.
• Other relevant duties and responsibilities as assigned.