Manager, GMP Production

CSBio

• $110K — $130K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in chemistry, chemical engineering, life sciences, or related field, or equivalent experience.
  • 7+ years of pharmaceutical, biotechnology, API, peptide, or regulated manufacturing experience.
  • 3+ years of direct people-management or manufacturing-leadership experience.
  • Strong cGMP, GDP, batch-record, deviation, CAPA, and validation knowledge.
  • Demonstrated experience in improving schedule performance, documentation, or yield.
  • Strong leadership, communication, prioritization, and problem-solving skills.

Responsibilities

  • Lead and ensure safe and compliant cGMP manufacturing operations.
  • Translate production plans into staffing and documentation readiness.
  • Manage hiring, onboarding, training, and performance of production personnel.
  • Review batch readiness and documentation for Quality review.
  • Collaborate with QA, QC, and other departments on project and regulatory processes.
  • Own area metrics for safety, documentation accuracy, and schedule adherence.
  • Drive process improvements while maintaining compliance and product quality.

Benefits

  • Medical, dental, and vision insurance with substantial employer contributions.
  • Basic life insurance paid by the company, with optional supplemental coverage.
  • Employer-paid disability insurance.
  • Generous 401k match of 10% at a 1:1 ratio.
  • 10 days of paid time off (PTO) and designated holidays.
  • Reimbursement for carpooling, clean air vehicles, and cell phones.
  • Employee recognition programs and social events.
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

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