Job Description

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 California-licensed pharmacist to support a 503A pharmacy operation. The Pharmacist-in-Charge will own daily pharmacy operations, inspection readiness, personnel oversight, quality systems, and compliance with applicable federal and California pharmacy requirements.


Job Duties:

• Support the pharmacy build, licensing, permitting, inspection-readiness, opening, and renewal plan in coordination with leadership and qualified regulatory advisors.
• Serve as the proposed Pharmacist-in-Charge and accept responsibility for daily pharmacy operations and legal compliance upon Board approval.
• Define the operating model, hours, staffing plan, pharmacist-to-technician ratios, supervision, escalation pathways, and launch-readiness criteria.
• Develop, approve, and maintain policies and procedures for prescription processing, dispensing, counseling, compounding, recordkeeping, complaints, errors, recalls, and continuity of operations.
• Oversee personnel licensing, onboarding, training, competency, scheduling, and performance; exercise independent professional judgment on patient safety and staffing.
• Establish controls for procurement, receiving, storage, temperature, inventory, controlled substances, expiration, returns, waste, loss prevention, and diversion response.
• If included in the approved license scope, oversee nonsterile, sterile, or hazardous compounding in accordance with applicable permits, USP chapters, environmental controls, testing, and documentation.
• Maintain inspection-ready records and manage Board, DEA, payer, quality, or other authorized inspections and corrective actions.
• Monitor quality and operating metrics, investigate errors and near misses, and implement sustainable corrective actions.
• Partner with clinical, Quality, supply-chain, IT, and finance teams while preserving the PIC's independent professional judgment.

Requirements

• Active, unrestricted California pharmacist license in good standing.
• Eligible for approval by the California State Board of Pharmacy as PIC for the proposed pharmacy.
• Completion of the Board-provided PIC training within the required timeframe.
• 5+ years of pharmacist experience, including pharmacy operations, compliance, quality, or leadership responsibility.
• Experience with pharmacy licensing, inspection readiness, openings, major operational changes, or corrective actions.
• Strong knowledge of applicable California and federal pharmacy, controlled-substance, recordkeeping, and patient-safety requirements.

Benefits

• Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee's family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
• Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
• Disability insurance 50% standard employer paid.
• 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
• Carpool, clean air vehicle, and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Quarterly sponsored team building activities

Job Tags

Contract work, Worldwide, 2 days per week

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