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AbzenaPosted 1 month ago

Manufacturing Manager - Shift B

On-siteSan Diego, California, United States

Full TimeMedium

Job Summary

Lead day-to-day manufacturing activities for upstream, downstream, and process support operations at Abzena's San Diego cGMP facility, ensuring campaigns execute safely and efficiently per approved batch records and cGMP requirements. Manage manufacturing readiness for technology transfers and process validation while driving operational excellence, team development, and continuous improvement initiatives. Collaborate with cross-functional teams to transfer processes, oversee GMP activities, and serve as the subject matter expert during health authority inspections. This role supports clinical and commercial biologics programs including monoclonal antibodies, recombinant proteins, bispecifics, and ADCs. The successful candidate will lead a team with 8+ years of cGMP experience, reporting to senior management. Schedule involves rotating shifts (8, 10, or 12 hours) subject to change.

Required Qualifications

  • Bachelor's degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Biology, Life Sciences, or related discipline
  • 8+ years of experience in biopharmaceutical or biologics manufacturing within a regulated cGMP environment
  • 3+ years of direct people leadership experience
  • Strong understanding of biologics manufacturing processes, including upstream and downstream operations
  • Experience supporting clinical and/or commercial biologics manufacturing
  • Thorough knowledge of cGMP regulations, quality systems, and regulatory expectations
  • Demonstrated success leading teams in a fast-paced manufacturing environment
  • Strong problem-solving, organizational, communication, and leadership skills
  • Travel between Abzena sites (local San Diego CA facilities) as needed
  • Ability to sit or stand for extended periods of time
  • Frequently lift and or move objects at least 50 pounds in weight
  • Stand/walk during entire length of shift
  • Use arms, hands and fingers to handle, feel or reach
  • Ability to climb, balance, stoop, kneel, crouch, or crawl
  • Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus

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