Manager, GMP Production

Yowei Therapeutics; Milpitas (CA); Presencial; USD 140.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance (Kaiser HMO or Blue P

Dental insurance

Vision insurance

Life insurance

Disability insurance

401k with 10% match

Paid time off: 10 days

Company holidays

Commuter benefits

Descripción de la vacante

Yowei Therapeutics seeks a hands-on Manufacturing Manager to lead safe, compliant cGMP peptide-production operations. You will own staffing, scheduling, batch readiness, documentation quality, and CAPA coordination across QA, QC, Materials, Facilities, Validation, and Project Management.

You will drive improvements while maintaining regulatory standards and product quality. The role requires a Bachelor’s degree in a relevant field, 7+ years of regulated manufacturing experience, and 3+ years of

Formación

• 7+ years of pharma/biotech, API, peptide, or similarly regulated manufacturing experience.
• 3+ years of direct people-management or manufacturing leadership experience.
• Strong cGMP, GDP, batch-record, deviation, CAPA, change-control, validation, and inspection-readiness knowledge.
• Demonstrated experience improving schedule performance, documentation quality, capacity, or yield.
• Willingness to work Saturdays and/or Sundays.

Responsabilidades

• Lead daily cGMP manufacturing operations, ensuring batches are executed safely, on schedule, and per approved records.
• Translate production plan into staffing, room, equipment, materials, and documentation readiness; address constraints early.
• Manage supervisors and production personnel, including hiring, onboarding, scheduling, training, qualification, coaching, and performance management.
• Review batch readiness and execution status; ensure records are complete, accurate, contemporaneous, and ready for QA review.
• Partner with QA, QC, Materials, Facilities, Validation, and Project Management on deviations, CAPAs, change controls, investigations, release dependencies, and customer commitments.
• Own area metrics for safety, scheduling, yield, cycle time, deviations, training, downtime, and capacity.
• Drive practical process improvements while preserving validated state, product quality, data integrity, and regulatory compliance.
• Ensure equipment, rooms, utilities, cleaning, calibration, maintenance, and supplies are ready for scheduled work.
• Support audits, inspections, customer visits, technology transfer, scale-up, and new-product introduction.
• Prepare staffing and capital plans and manage operating budgets within approved authority.
• Able to work on Saturdays and/or Sundays
• Carpool, clean air vehicle, and cell phone reimbursement

Conocimientos

Leadership

Cross-functional

Problem-solving

Communication

Project management

Quality systems

Schedule adherence

Documentation

Detail-oriented

Educación

Bachelor’s degree in chemistry, chemical engineering, life sciences, or related field

Descripción del empleo

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 a hands-on Manufacturing Manager to lead safe, compliant, and reliable cGMP peptide-production operations. The Manager will own people, schedule execution, batch readiness, documentation quality, deviation response, capacity, and continuous improvement across assigned manufacturing areas. Core duties and responsibilities include the following:

• Lead daily cGMP manufacturing operations and ensure batches are executed safely, on schedule, and in accordance with approved records and procedures.

• Translate the approved production plan into staffing, room, equipment, material, and documentation readiness; elevate constraints early.

• Manage supervisors and production personnel, including hiring, onboarding, scheduling, training, qualification, coaching, and performance management.

• Review batch readiness and execution status; ensure records are complete, accurate, contemporaneous, and ready for Quality review.

• Partner with QA, QC, Materials, Facilities, Validation, and Project Management on deviations, CAPAs, change controls, investigations, release dependencies, and customer commitments.

• Own area metrics for safety, right-first-time documentation, schedule adherence, yield, cycle time, deviations, training, downtime, and capacity.

• Drive practical process improvements while preserving validated state, product quality, data integrity, and regulatory compliance.

• Ensure equipment, rooms, utilities, cleaning, calibration, maintenance, and supplies are ready for scheduled work.

• Support audits, inspections, customer visits, technology transfer, scale-up, and new-product introduction.

• Prepare staffing and capital plans and manage operating budgets within approved authority.

• Able to work on Saturdays and/or Sundays

• Bachelor’s degree in chemistry, chemical engineering, life sciences, or a related field, or equivalent experience.

• 7+ years of pharmaceutical, biotechnology, API, peptide, or similarly regulated manufacturing experience.

• 3+ years of direct people-management or manufacturing-leadership experience.

• Strong cGMP, GDP, batch-record, deviation, CAPA, change-control, validation, and inspection-readiness knowledge.

• Demonstrated experience improving schedule performance, documentation quality, capacity, or yield.

• Strong leadership, communication, prioritization, and cross-functional problem-solving skills.

• 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