QC Manager, Analytical Stability

Abzena Inc.•San Diego, CA

1d•Onsite

About The Position

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.

Requirements

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.
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

Nice To Haves

Occasional travel may be required between Abzena sites, including San Diego, California and Bristol, Pennsylvania.
Flexibility to work adjusted hours based on business needs

Responsibilities

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.
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.