Senior Stability Specialist, Quality Control

Job Title: Senior Stability Specialist, Quality Control
Location: Santa Monica

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 5 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

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 report, 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 Manger of Quality Control.

This position includes occasional weekend technical support and operates on one of the following shift, which is subject to change:

• Monday to Friday, 8:00AM - 4:30 PM

Accountabilities:

• Author, review and execute Protocols and 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.

Where can I find out more?

• Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
• Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
• Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

• Our US Footprint: Powering Scientific Innovation - YouTube

The annual base pay (or hourly rate of compensation) for this position ranges from $100,786 to $151,179. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.