Manufacturing Manager - Shift A
On-siteSan Diego, California, United States
Job Summary
Lead day-to-day manufacturing activities for upstream, downstream, and process support operations at Abzena's San Diego cGMP facility, ensuring production campaigns execute safely and efficiently under cGMP requirements. Manage manufacturing readiness for technology transfers and process validation while driving continuous improvement initiatives and cross-functional collaboration. Coordinate schedules to meet client commitments, monitor performance metrics, and lead teams through health authority inspections. Report significant quality, compliance, and safety risks to senior management. Shift A rotation begins with 8-hour days Monday through Friday, progressing to 10-hour days Monday through Thursday, then 12-hour days Sunday through Tuesday with alternating Wednesdays after 90 days. Requires a Bachelor's degree in life sciences and 8+ years in biologics manufacturing.
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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