Lead, mentor, and develop QC scientists and associates, fostering a culture of technical excellence, accountability, and continuous improvement.
Ensure all personnel are fully trained in technical competencies, cGMP, data integrity, and laboratory safety.
Communicate clear goals, priorities, and performance expectations to direct reports.
Partner with facilities teams to maintain a state of control for laboratory equipment, including calibration, qualification, and preventive maintenance.
Drive operational readiness and resource planning to support analytical testing needs.
Oversee end‑to‑end stability program management, including study design, protocol development, execution, and lifecycle oversight.
Ensure all stability protocols and reports meet ICH, internal SOP, and quality system requirements.
Manage sample logistics, material staging, and tracking for all stability studies.
Monitor active stability programs, ensuring on‑time pulls, testing, reporting, and issuance of Stability Summary Sheets.
Maintain accurate, audit‑ready stability inventory and documentation.
Lead qualification, lifecycle management, retesting, and documentation for reference standards.
Oversee inventory, testing schedules, stability requirements, and timely issuance of certificates.
Train and guide laboratory personnel supporting reference standard activities.
Represent QC Stability in internal meetings, client interactions, audits, and cross‑functional forums.
Author or review deviations, investigations, CAPAs, change controls, and risk assessments related to stability and reference standards.
Support or lead investigations involving OOS, OOT, non‑conformances, and laboratory events.
Review analytical data packages, perform data trending, and troubleshoot complex laboratory issues.
Collaborate closely with Manufacturing, Analytical Development, Tech Transfer, Regulatory, and Quality Assurance teams.
Contribute to long‑term planning for equipment, staffing, and organizational structure.
Recommend and justify new equipment, headcount, promotions, and process improvements.
Bachelor’s degree or higher in Chemistry, Biology, or related Life Sciences discipline.
10+ years of QC experience in GMP pharmaceutical or biotechnology laboratories.
5–6+ years of people management experience in QC laboratory environments.
Deep expertise with analytical platforms including HPLC, SDS‑PAGE, ELISA, Capillary Electrophoresis, cIEF (Maurice), UV‑Vis, cell‑based potency assays, and compendial methods.
Strong working knowledge of ICH, USP, EP, and FDA guidelines related to method development, validation, and stability studies.
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.
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.
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