Summary

AstraZeneca is seeking an energetic and experienced individual with cell therapy quality control background to join our Quality Control (QC) team. The successful candidate will contribute to the advancement of our product pipeline by supporting all stability testing across multiple products and sites. The Senior Stability Specialist is a subject matter expert responsible for coordinating stability testing, facilitating stability execution, authoring stability reports, managing EDAs, and leading all investigations related to stability. This individual will work closely with the QC operation teams supporting the organizational vision. This role is based in Santa Monica, CA and reports to Manager of Quality Control. This position includes occasional weekend technical support and operates on one of the following shifts, which is subject to change: Monday to Friday, 8:00AM - 4:30 PM.

Job description

Introduction to Role

AstraZeneca is seeking an energetic and experienced individual with cell therapy quality control background to join our Quality Control (QC) team. The successful candidate will contribute to the advancement of our product pipeline by supporting all stability testing across multiple products and sites. The Senior Stability Specialist is a subject matter expert responsible for coordinating stability testing, facilitating stability execution, authoring stability reports, managing EDAs, and leading all investigations related to stability. This individual will work closely with the QC operation teams supporting the organizational vision. This role is based in Santa Monica, CA and reports to Manager of Quality Control. This position includes occasional weekend technical support and operates on one of the following shifts, which is subject to change: Monday to Friday, 8:00AM - 4:30 PM.

Accountabilities

Author, review and execute protocols relating to Drug Product and Drug Substance stability.
Quality Stability Subject Matter Expert (SME) during health authority inspections, client audits, and internal reviews.
Author stability protocols, summary reports, and regulatory submission documents.
Assess stability data, perform statistical analyses (e.g., using Prism or JMP), and evaluate trends to determine product shelf-life and retest periods.
Lead investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), atypical results, and stability-related deviations or CAPAs (Corrective and Preventive Actions).
Coordinate sample testing with CRO, ship test materials and monitor test results.
Laboratory Equipment maintenance: Schedule all PMs and repairs for QC labs.
Support in sample submissions, receiving, verify, store, shipment of samples, and logbook review.
Perform other related duties and responsibilities as assigned.

Essential Skills/Experience

PhD degree preferably in a related science field or equivalent with 0-2 years of relevant CGMP experience; OR Master's degree preferably in a related science field or equivalent with 2-3 years of relevant CGMP experience; OR Bachelor's preferably in a related science field or equivalent with 3-5 years of relevant CGMP experience; OR Associate's degree preferably in a related science field or equivalent with 5-7 years of relevant CGMP experience.
Minimum 3 years commercial stability management.
Demonstrated knowledge of regulatory guidance and industry best practices.
Expert knowledge and understanding of stability design, execution and management of long-term, accelerated and in-use stability studies.
Demonstrated knowledge leading major investigations related to stability, such as LIR, EC, OOT and OOS.
Must demonstrate effective organizational skills and ability to manage multiple projects.
Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting and able to adjust workload based upon changing priorities.

Requirements

PhD in a related science field or equivalent with 0-2 years of relevant CGMP experience; OR Master's degree with 2-3 years; OR Bachelor's degree with 3-5 years; OR Associate's degree with 5-7 years
Minimum 3 years commercial stability management
Demonstrated knowledge of regulatory guidance and industry best practices
Expert knowledge of stability design, execution and management of long-term, accelerated and in-use stability studies
Demonstrated knowledge leading major investigations related to stability such as LIR, EC, OOT and OOS
Effective organizational skills and ability to manage multiple projects
Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting
Ability to adjust workload based upon changing priorities

Benefits

Retirement Programs
Paid Time Off
Health Coverage
Dental Coverage
Vision Coverage
Short-Term Incentive Bonuses
Equity-Based Awards

Company overview

AstraZeneca is a global, science-led, patient-focused pharmaceutical company dedicated to accelerating the delivery of life-changing medicines that create enduring value for patients, society, and shareholders. With a workforce of over 94,300 employees worldwide, the company operates across three core therapy areas: Oncology, BioPharmaceuticals (including Cardiovascular, Renal & Metabolism, Respiratory & Immunology), and Rare Disease. Headquartered in Cambridge, UK, AstraZeneca maintains strategic R&D centers in Cambridge, Gaithersburg (US), Boston (US), Gothenburg (Sweden), Shanghai, and Beijing. The company generated $54.1 billion in total revenue in 2024 and invested $13.6 billion in scientific research and development. AstraZeneca's bold aspiration is to be pioneers in science, lead in disease areas, and transform patient outcomes, with a goal to launch 20 new medicines and achieve $80 billion in total revenue by 2030. The company is recognized for its commitment to sustainability, health equity, and creating an inclusive work environment where diverse perspectives drive innovation.