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.
FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local Jaws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
Abzena is the leading end-to-end bioconjugate, ADC, and complex biologics CDMO + CRO. From discovery through commercial launch, we support customers with fully integrated programs or individual services designed to de-risk and streamline the development of new treatments for patients in need. With the ability to tailor its strategy and customer experience to each project, Abzena develops and implements innovative solutions that enable biotech and biopharma companies to realize the full potential of their molecule and move medicines forward faster. The company has research, development, and cGMP facilities across locations in San Diego, CA, Bristol, PA, and Cambridge, UK.
