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CSBio
Milpitas, CA, US
Source: CSBio careers · View original posting
From CSBio's posting. “We” and “our” refer to the employer.
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.
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.
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