QC Stability Manager

San Diego, CA

Quality – Quality Control /

Full Time /

On-site

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.

As the QC Stability Manager, you will lead a high‑performing Quality Control team responsible for ensuring the integrity, reliability, and regulatory compliance of stability programs and reference standard management across Abzena’s biopharmaceutical operations. This role blends scientific expertise, operational leadership, and cross‑functional influence — ideal for a seasoned QC leader who thrives in a fast‑paced, growth‑oriented environment.

Responsibilities

People Leadership & Laboratory Excellence

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.

Stability Program Ownership

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.

Reference Standard Strategy & Oversight

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.

Quality, Compliance & Technical Support

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.

Strategic Planning & Organizational Growth

Contribute to long‑term planning for equipment, staffing, and organizational structure.
Recommend and justify new equipment, headcount, promotions, and process improvements.

Qualifications

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.

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.

$120,000 - $150,000 a year

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 laws.

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 and identifying potential inconsistencies or verification signals in application materials based on available information. 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.

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