Gmp Materials Specialist

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.

Seeking a detail-oriented Materials Specialist to support receiving, inventory, sampling coordination, material status, staging, and traceability for peptide manufacturing and laboratory operations.

Key Responsibilities

• Receive materials and components; verify shipments, quantities, condition, documentation, and purchase-order information.
• Apply and maintain correct quarantine, released, rejected, expired, and other status controls in accordance with approved procedures.
• Coordinate or perform approved sampling, labeling, storage, movement, staging, dispensing support, and material issuance.
• Maintain accurate lot, location, quantity, expiration, reservation, transaction, and reconciliation records.
• Perform cycle counts, investigate discrepancies, and support physical inventory and corrective actions.
• Prepare material kits for Manufacturing or QC and confirm readiness against current schedules.
• Monitor storage conditions, temperature records, housekeeping, segregation, and safety requirements.
• Support returns, destruction, supplier issues, audits, and inspection-readiness activities.
• Report shortages, damage, excursions, documentation gaps, or status conflicts immediately.

Requirements

• High school diploma or equivalent; associate degree preferred.
• 2+ years of materials, warehouse, inventory, manufacturing, laboratory, or logistics experience.
• Strong attention to detail, documentation, organization, and basic computer skills.
• Ability to follow SOPs and work safely with regulated, temperature-controlled, or hazardous materials.
• Ability to perform essential standing, lifting, material-handling, and PPE requirements with reasonable accommodation.
• Experience in GMP pharmaceutical, biotechnology, chemical, or laboratory operations

Preferred Qualifications

• Experience with ERP, inventory, barcode, or warehouse-management systems.
• Forklift, hazardous-material, cold-chain, or sampling experience, if required by the final assignment.

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