Stability Manager
AstraZeneca

Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

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.

About AstraZeneca in Gaithersburg, MD:

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.

The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you'll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.

Summary of the group

The Analytical Sciences GMP group is responsible for analytical support of clinical stage biopharmaceutical products in accordance with GMP regulations. This includes management of: lot release and stability programs, reference standards and critical reagents, analytical tech transfer, and sample chain of custody. The team engages with analytical development and manages assays across multiple analytical disciplines including: chromatography, electrophoresis, immunoassay, bioassay and device functionality methods. Members of the Analytical Sciences GMP department work closely with Analytical Sciences development personnel, Clinical Supply Chain, CMC and Quality Assurance across all stages of clinical development (pre-IND to BLA).

Position Summary

The Analytical, Quality, and Logistics (AQL) department in AstraZeneca, Gaithersburg is recruiting candidates for a Stability Manager position in a GMP stability testing group responsible for analytical testing of biopharmaceutical products to support regulatory filings for clinical products, and for marketing applications.

The primary responsibility of the stability manager position is the management and oversight of stability programs, and the applicant should be experienced and fully competent in the area of biopharmaceutical stability.

The responsibilities of the position include but are not limited to:

• Design, execute and manage stability program(s) to support clinical development.
• Ensure compliance of stability program(s) to internal and external quality and regulatory requirements.
• Develop stability strategy and provide guidance on strategy and requirements to other personnel.
• Represent AQL (and AstraZeneca as applicable) in cross -functional teams, internal and external.
• Coordinate work activities of other personnel.
• Generate stability protocols and reports, including stability protocol design and maintenance, data review and trend evaluation, writing and evaluating investigations, and addressing compliance challenges related to stability.
• Author and review stability sections in regulatory submissions.
• Author responses to information requests and questions from Health Authorities.
• Effectively communicate stability issues to project teams and upper management.
• Lead and participate in stability or quality investigations.
• Manage technical transfer of stability program(s) to partner sites or Contract Testing Laboratories, as appropriate.
• Lead process improvement efforts to enhance stability systems, compliance, and procedures.
• Author stability procedures and guidance documents

Skills and Abilities

The successful candidate must be able to work effectively under limited direction and must be able to establish their own priorities and timelines. Good writing, presentation, communication, and organizational skills are essential.

Educational Requirements

Bachelor's degree with 10-13 years of experience

Master degree with 8-10 years of experience

PhD with 0+ years of experience

Position Requirements

The successful candidate must have significant experience in the field of biopharmaceutical stability and possess knowledge of applicable international guidelines for stability. A broad understanding of the principles of stability, and the ability to apply these to different situations is critical. The ability to work without direct supervision and to advise/ train less experienced scientist are requirements. Prior experience in a GMP compliant analytical environment, and the ability to interpret scientific data, troubleshoot problems and provide practical solutions are also requirements. Knowledge of analytical methods for analysis of well-characterized biologics is desirable.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

---