QC Manager, Analytical Stability

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 QC Stability Manager is responsible for leading and supporting GMP large-molecule stability testing across all phases of client programs within QC. This role provides strategic and operational leadership for the QC Stability function and manages a team of QC professionals. The position requires strong experience in QC laboratory operations, stability program management, and a deep understanding of cGMP/GDP requirements. Leading analytical methods support activities related to stability testing, product control programs, and reference standard management. Oversee daily operations of the QC Stability function in a biopharmaceutical manufacturing environment supporting multiple products and client programs. Drive continuous improvement and operational efficiency across stability workflows, systems, and processes. Ensure compliant operation and maintenance of stability-related infrastructure, documentation, equipment preventive maintenance, calibration, qualification, and training programs.

Responsibilities People Leadership and Lab Management:

Provide leadership, mentorship, and development opportunities for QC staff and associates. Ensure appropriate training of personnel in technical skills, cGMP compliance, data integrity, and safety requirements. Communicate departmental goals, priorities, and performance expectations to direct reports. Support facility teams in ensuring timely maintenance, calibration, and qualification of laboratory instruments and equipment.

Stability Program and Reference Standard Management:

Manage and oversee stability study design, protocol development, execution, and lifecycle management. Coordinate stability protocol and report authoring in accordance with ICH guidelines, internal SOPs, and quality system requirements. Oversee stability study setup, including sample management, material staging, and fraction tracking. Track and monitor all active stability programs, including pull schedules, testing timelines, report completion, and Stability Summary Sheet issuance. Maintain accurate and current stability inventory records. Lead reference standard qualification, management, retesting, and lifecycle activities. Monitor inventory, testing schedules, stability requirements, and timely issuance of associated certificates. Provide training and oversight for laboratory personnel supporting reference standard activities. Represent QC Stability in internal meetings, client meetings, audits, and cross-functional discussions related to stability and reference standards. Ensure compliant analytical laboratory support and resource planning. 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. Partner closely with Manufacturing, Analytical Development, Tech Transfer, Regulatory, and Quality Assurance teams. Support strategic planning for new equipment, staff capacity planning, organizational structure, and resource requirements. Recommend and justify additional equipment, staffing, promotions, or organizational changes as needed. 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, SDS-PAGE, 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.

Core Competencies:

Excellent written, verbal, and interpersonal communication skills Strong technical writing and documentation skills Proficiency in Microsoft Word, Excel, and PowerPoint Strong organizational skills with ability to manage multiple priorities in a fast-paced, deadline-driven environment Ability to proactively communicate risks, issues, and solutions to management Strong troubleshooting, problem-solving, and decision-making skills Detail-oriented with strong analytical mindset Ability to work independently while collaborating effectively across teams Experience supporting controlled document generation, review, and approval processes Ability to draft and review Certificates of Analysis and reagent specification documents Flexibility to work adjusted hours based on business needs Physical Requirements Frequently lift and or move objects up to 20 pounds. Stand/walk during entire length of shift. Use of arms, hands and fingers to handle, feel or reach. Ability to climb, balance, stoop, kneel, crouch, or crawl. Visual abilities include near and far sight, color, peripheral vision, depth and ability to focus.

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. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.