Manager, CLIA Operations

CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development with a focus on cGMP 1994 we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies 2004 we opened our peptide production facility in Menlo Park CA and in 2014 we expanded our production capability through the addition of a new state of the art building dedicated to cGMP peptide 2017 we passed a FDA inspection and were recommended to be approved for commercial drug substance 2023 we added additional cGMP clinical production capacity in Milpitas CA.

We are seeking a hands-on clinical laboratory implementation leader to plan build license certify and launch a new laboratory supporting the companys oncology and microbiology strategy. Core duties are included below.

Job Duties:

• 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.

• Bachelors 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.

• Medical dental and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 90% for Employee and 75% for Employees 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 ($20000 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

Required Experience:

Manager