Manager, CLIA Operations

About the role

CSBio is a peptide contract manufacturing company founded in 1993. Initial products were automated synthesizers for manufacturing and process development, focusing on cGMP production. In 1994 opened custom peptide facility; 2004 opened peptide production facility in Menlo Park, CA; 2014 expanded with new state‑of‑the‑art building for cGMP peptide production; 2017 passed FDA inspection and was recommended for approval for commercial drug substance manufacturing; 2023 added additional cGMP clinical production capacity in Milpitas, CA. The company seeks a hands‑on clinical laboratory implementation leader to plan, build, license, certify, and launch a new laboratory supporting the oncology and microbiology strategy.

Responsibilities

• Support build and maintenance of an integrated plan for laboratory design, licensing, CLIA certification, validation, inspection readiness, launch, and stabilization
• Coordinate facility layout, utilities, biosafety, environmental requirements, equipment selection, installation, qualification, maintenance, calibration, and service coverage
• Lead preparation of federal CLIA and applicable California registration or licensing materials and coordinate with CMS, CDPH Laboratory Field Services, and any selected accreditation organization
• Establish the laboratory quality system, including documents, training, competency, specimen handling, validation or verification, QC, proficiency testing, reporting, retention, occurrence management, CAPA, and continuous improvement
• Ensure assays are implemented under approved validation or verification plans appropriate to intended use, methodology, regulatory status, and complexity
• Select and implement appropriate LIS/LIMS and operational systems with access controls, audit trails, interfaces, review, downtime, and retention procedures
• Maintain qualification, training, and competency files
• Prepare for surveys and inspections and manage deficiency responses and corrective actions through closure

Requirements

• Bachelor's degree in clinical laboratory science, medical technology, biology, chemistry, health administration, engineering, or a related field
• 5+ years of relevant clinical laboratory operations, quality, regulatory, implementation, or leadership experience
• Working knowledge of CLIA requirements and California clinical-laboratory licensing and personnel requirements
• Experience with laboratory quality systems, method validation or verification, equipment qualification, personnel competency, proficiency testing, inspections, and CAPA
• Strong project-management, documentation, risk-assessment, and cross-functional leadership skills

Benefits

• Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 90% for Employee and 75% for Employee's family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
• 401k 10% 1:1 match
• PTO policy. 10 days PTO
• Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
• Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental)
• Disability insurance 50% standard employer paid
• Carpool, clean air vehicle, and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Quarterly sponsored team building activities