Full Job Description
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; escalate 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.
Requirements
- 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.
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