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Yowei Therapeutics
Milpitas, CA, US
Source: Yowei Therapeutics careers · View original posting
From Yowei Therapeutics's posting. “We” and “our” refer to the employer.
Yowei Therapeutics and Yowei Oncology are stealth-stage life-sciences companies working closely with CSBio to advance peptide-based clinical programs. Their work spans longevity and peptide therapeutics, clinical trials, evaluation of a 503A pharmacy model, personalized synthetic neoantigen peptide oncology programs, and supporting microbiology and laboratory capabilities.
Together, they are building the clinical, pharmacy, data, laboratory, and operational infrastructure needed to responsibly translate peptide programs into patient-facing studies and services. Both companies expect to remain in stealth through Q1 2027.
CSBio is a peptide contract manufacturing founded in 1993. CSBio initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, CSBio opened a custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide.
In 2004, CSBio opened a peptide production facility in Menlo Park, CA and in 2014, CSBio expanded production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, CSBio passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, additional cGMP clinical production capacity was added in Milpitas, CA.
We are seeking an experienced Quality Control Analyst to perform and review analytical testing supporting raw-material, in-process, release, stability, validation, and investigation activities. Core duties and responsibilities include the following:
Perform and document routine and complex analytical testing in accordance with approved methods, specifications, SOPs, protocols, and schedules.
Review raw data, calculations, chromatograms, audit trails, worksheets, and results for accuracy, completeness, and compliance.
Support or lead method transfer, verification, validation, troubleshooting, and lifecycle improvements for assigned methods.
Execute raw-material, in-process, release, stability, cleaning, or investigation testing as assigned.
Lead or support laboratory investigations, OOS/OOT assessments, deviations, CAPAs, and change controls.
Operate, maintain, calibrate, and troubleshoot analytical instruments and laboratory systems; coordinate service when needed.
Prepare and revise methods, SOPs, protocols, reports, specifications, forms, and training materials.
Train and mentor analysts and provide technical guidance while preserving independent review requirements.
Plan work against manufacturing and project priorities and communicate constraints or risks early.
Support inspections, customer audits, data requests, and continuous-improvement initiatives.
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