GMP Peptide Production Manager — Lead & Optimize Operations

Yowei Therapeutics; Milpitas (CA); On-site; USD 140,000 - 170,000; Full time

Benefits offered by this job

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

Job summary

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

Qualifications

• 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.

Responsibilities

• 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

Skills

Leadership

Cross-functional

Problem-solving

Communication

Project management

Quality systems

Schedule adherence

Documentation

Detail-oriented

Education

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

Job description

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