Manager, CLIA Operations

CSBio; Milpitas (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401k with company match

PTO 10 days

Paid holidays

Life insurance

Disability insurance

Commuter benefits

Employee recognition program

Team building activities

Job summary

CSBio in Milpitas, CA seeks a hands-on clinical laboratory implementation leader to plan, build, license, certify, and launch a new laboratory supporting the company's oncology and microbiology strategy. Core duties include designing the facility, coordinating regulatory approvals, and establishing a robust quality system.

The role requires 5+ years in clinical lab operations or leadership, strong CLIA knowledge, and proven project-management skills to drive compliance, validation, and CAPA

Qualifications

• Bachelor's degree in clinical laboratory science, medical technology, biology, chemistry, health administration, engineering, or 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.

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.

Skills

Project management

Regulatory leadership

Quality systems

Cross-functional leadership

Risk assessment

Documentation

CLIA knowledge

Education

Bachelor's degree in clinical laboratory science or related field

Tools

LIS/LIMS systems

Job description

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 production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 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 production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 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 company's 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

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