We are seeking a highly experienced Quality Control (QC) Manager to lead cGMP QC operations supporting recombinant proteins and monoclonal antibody (mAb) manufacturing within a world-class biologics CDMO environment. This role is responsible for ensuring the execution, compliance, and continuous improvement of QC testing programs supporting clinical and commercial biologics release, raw materials/in-process testing, and manages a team of qualified QC professionals. This role is highly visible and interfaces directly with Manufacturing, QA, MSAT, Regulatory Affairs, and external clients, serving as a key QC subject matter expert during audits and client meetings. This position requires strong experience in QC laboratory operations and a deep understanding of cGMP/GDP testing requirements. Responsibilities QC Leadership and Operational Management: • Lead daily operations of QC Analytical lab supporting biologics testing (mAbs, recombinant proteins, fusion proteins) • Oversee testing activities for: • Drug substance and drug product release • Raw materials and in-process samples • Reference Standard management • Stability studies (ICH-compliant programs) • Testing associated with Qualification/Validation of Test Methods • Ensure timely execution of testing to support manufacturing schedules and batch disposition • Drive training programs, scheduling, and technical capability development • Timely maintenance of calibration, PM, qualification of lab instruments • Lead daily operations of QC Analytical lab supporting biologics testing (mAbs, recombinant proteins, fusion proteins) • Provide leadership, mentorship, and develop QC associates (typically 4-6 + team members) • Communicate departmental goals, priorities, and performance expectations to direct reports • Drive lean laboratory practices, resource planning, and operational excellence initiatives • Support strategic planning for new equipment, staff capacity planning, organizational structure, and resource requirements. • Improve turnaround time (TAT), right-first-time execution, and lab efficiency • Maintain accurate and current release/stability inventory records, testing schedules, and timely issuance of associated CoA's and summary sheets. • Represent QC analytical in internal meetings, client meetings, audits, and cross-functional discussions related to stability and reference standards. • Author and/or review deviations, investigations, CAPAs, change controls, and risk assessments related to stability and reference standard programs. • Support or lead investigations involving OOS, OOT, non-conformances, and laboratory events. • Review analytical data packages, perform data trending, and provide troubleshooting support for complex laboratory issues. • Occasional travel may be required between Abzena sites, including San Diego, California and Bristol, Pennsylvania. Qualifications • Bachelor's degree or higher in Chemistry, Biology, or related Life Sciences discipline • Minimum 10 years of experience in QC GMP pharmaceutical or biotechnology laboratories within a cGMP-regulated environment • Minimum 5-6 years of people management experience in QC laboratory settings • Extensive knowledge of HPLC, ELISA, Capillary Electrophoresis (CE), cIEF (Maurice platform), UV-Vis, cell-based potency assay, and compendial methods. • Knowledge of ICH, EP, USP, and FDA guidelines relating to method development, qualification/validation, and stability studies. $120,000 - $150,000 a year FLSA: Exempt