Senior GMP Peptide Production Leader

Yowei Therapeutics; Milpitas (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

401k with match

PTO 10 days

company paid holidays

Job summary

Yowei Therapeutics seeks a hands-on Manufacturing Manager to lead safe, compliant cGMP peptide‑production operations. You will own staffing, schedule execution, batch readiness, and documentation quality, coordinating with QA, QC, Materials, Facilities, and Validation to ensure timely, quality production.

You will manage supervisors and staff, drive process improvements, and ensure readiness of equipment, rooms, and supplies, while supporting audits and technology transfer in a fast-paced

Qualifications

• 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.

Responsibilities

• 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.

Skills

Leadership

Communication

Cross-functional collaboration

Problem solving

Scheduling

GMP knowledge

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, schedule execution, batch readiness, and documentation quality, coordinating with QA, QC, Materials, Facilities, and Validation to ensure timely, quality production.

You will manage supervisors and staff, drive process improvements, and ensure readiness of equipment, rooms, and supplies, while supporting audits and technology transfer in a fast-paced