Manufacturing Lead - Shift A
On-siteSan Diego, California, United States
Job Summary
Lead day-to-day execution of upstream and downstream GMP manufacturing activities for Train 2, coordinating batch execution, material staging, and real-time direction for cell culture, harvest, purification, and bulk drug substance fills. Provide hands-on training for associates on aseptic techniques, cleanroom standards, and equipment operation while troubleshooting process and equipment issues. Review GMP documentation for compliance, support deviations and CAPAs, and champion EHS practices. Make adjustments to production schedules and lead continuous improvement initiatives. Partner with QA, QC, Engineering, and Supply Chain teams to ensure operational readiness and regulatory adherence.
Required Qualifications
- BA/BS degree that included laboratory work in a chemistry, biology, or related field
- At least 3 – 4 years of purification experience in a GMP pharmaceutical/biotech environment role
- Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities
- Skilled in aseptic handling, including BSC operations to maintain the integrity of sterile systems
- Skilled with using single-use technologies
- Strong technical and mechanical aptitude in bioprocessing
- Knowledge of purification using column chromatography
- Experience leading, training, and coaching peers
- Computer proficiency
- A proven ability to confidently compute basic arithmetic operations
- Travel between Abzena sites (local San Diego CA facilities) as needed
- Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time
- Frequently lift and or move objects at least 30 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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