Manufacturing Supervisor I - Shift A

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Manufacturing Supervisor is responsible for leading GMP manufacturing operations supporting biologics production, including cell culture, fermentation, harvest, purification, and bulk drug substance manufacturing activities. This role provides direct supervision of manufacturing personnel, ensures compliance with current Good Manufacturing Practices (cGMP), and drives safe, efficient, and high-quality execution of manufacturing campaigns. The supervisor serves as a key operational leader, coordinating production activities, managing shift resources, supporting technology transfer and process validation activities, and partnering with Quality, Process Sciences, Supply Chain, Facilities, and MSAT teams to achieve production objectives. This role will be dedicated to the manufacturing operations of Train 2. Train 2 is a production line going from vial thaw in initial thaw and expansion to a 500L production reactor, followed by harvest, to finishing operations in downstream. **Example Plan Shifts/Training Schedule:** - First 2 weeks: 8 hour shifts, M-F - Next 1-2 months: 10 hour shifts, Mon-Thurs - After 90 days: 12 hour shifts, Sun-Tues & Alternating Wednesdays *Schedule is subject to change based on needs.* ### Responsibilities **Manufacturing Operations Leadership** 1. Supervise day-to-day upstream and downstream GMP manufacturing operations. 2. Lead production activities including media and buffer preparation, cell culture expansion, bioreactor operations, harvest, chromatography, ultrafiltration/diafiltration (UF/DF), and bulk filling activities. 3. Ensure manufacturing campaigns are executed according to approved batch records, SOPs, and manufacturing schedules. 4. Coordinate shift activities and allocate resources to meet production requirements. 5. Monitor manufacturing performance and address operational challenges in real time. 6. Drive adherence to production schedules while maintaining quality and compliance standards. **Team Leadership & Development** 1. Supervise, coach, mentor, and develop Manufacturing Associates and Senior Manufacturing Associates. 2. Conduct performance evaluations and establish development plans for team members. 3. Facilitate onboarding and qualification of new employees. 4. Promote a culture of safety, teamwork, accountability, and continuous improvement. 5. Lead daily shift meetings, production reviews, and operational communications. **GMP Compliance & Quality** 1. Ensure strict compliance with cGMP regulations, company procedures, and regulatory requirements. 2. Review and verify batch documentation for accuracy and completeness. 3. Support investigations, deviations, CAPAs, change controls, and quality events. 4. Participate in internal audits, client audits, and regulatory inspections. 5. Ensure proper documentation practices and data integrity standards are maintained. **Process Execution & Technical Support** 1. Provide technical oversight for upstream and downstream operations. 2. Support process transfers from development to GMP manufacturing. 3. Assist in process validation, engineering runs, and GMP campaign readiness activities. 4. Collaborate with MSAT, Process Development, and Engineering teams to improve process robustness and efficiency. 5. Troubleshoot manufacturing…