Associate Scientist, Stability Coordinator
Posted on Apr 13, 2021 by AstraZeneca
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.
The Analytical, Quality, and Logistics department in AstraZeneca, Gaithersburg is recruiting for a Stability Coordinator position in a GMP testing group responsible for analytical testing of biopharmaceutical products to support regulatory filings for clinical stage products. The primary responsibility of the stability coordinator position is the management and oversight of stability programs supporting clinical development.
The responsibilities of the position include but are not limited to:
o Design, execute and manage stability program(s) to support clinical development.
o Ensure compliance of stability program(s) to internal and external quality and regulatory requirements.
o 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
o Author and review stability sections in regulatory submissions
o Lead and participate in stability or quality investigations and effectively communicate stability issues to project teams and upper management
o Manage technical transfer of stability program(s) to partner sites or Contract Testing Laboratories, as appropriate.
o Lead process improvement efforts to enhance stability systems, compliance and procedures.
o Assist with the management of stability chambers and author stability procedures and guidance documents
The successful candidate must have knowledge of current GMP regulations for laboratory and ICH guidelines for stability. A broad understanding of analytical methods, ability to interpret scientific data, troubleshoot problems and provide practical solutions is also required. Prior experience in a GMP compliant analytical testing environment is preferred.
BS or MS in Chemistry, Biochemistry or related field
BS with a minimum of 8 years of experience in a GLP/GMP industry environment
MS with a minimum of 5 years of experience in a GLP/GMP industry environment
Skills and Abilities
The successful candidate must be able to work effectively in a team environment. Good writing, presentation, communication and organizational skills are essential.