Associate Scientist/Scientist - Analytical Quality and Logistics

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 ground breaking 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 balanced. This includes a fitness centre, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria, and copy centre. This is where you’ll find newly designed, activity-based workspaces to suit a variety of working styles while increasing collaboration between teams. 

AstraZeneca has an opportunity for a Scientist in the Physicochemical Development Group within the Analytical Sciences Department in Gaithersburg, MD.

Summary of the group

The Analytical Sciences GMP department within Research and Development 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. 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 (from pre-IND to BLA (Biologics License Application

Responsibilities:

• As an AQL compliance team specialist, this role will be a non-laboratory based position focused on supporting laboratory operations and improving quality/compliance
• Will lead and/or support the creation and revision of master specifications for clinical projects
• Will lead and/or support the creation of Certificates of Analysis
• Will lead and/or support compliance management activities related to standard operating procedures, logbooks (paper and electronic), investigations, deviations, corrective actions, and change controls
• Will lead and/or support laboratory management activities related to equipment on/off boarding, calibration, validation, revalidation, and preventative maintenance
• Will lead and/or support audit management activities related to audit preparation, internal/external audit support, and audit responses
• Will lead and/or support training management activities related to training administration, job aids, and establishment of training curricula
• Will lead and/or support the 6S program within the Analytical Sciences department to enable more efficient, effective, and safer laboratory workspaces
• Will lead and/or support continuous improvement initiatives/projects within the Analytical Sciences department

Education & Experience Requirements

Associate Scientist

 A minimum of a bachelor's degree in biology, biochemistry or related degree with 2 + years of industry-related experience.

Scientist

A minimum of a bachelor's degree in biology, biochemistry or related degree with 5+ years of industry-related experience.

Or

Master’s degree with 2+ years of experience.

Required Skills

• Prior experience with one or more analytical techniques used for characterization and/or quantitation of protein products, such as: chromatography (SEC, IEC, RPLC), electrophoresis (cIEF, CGE), immunoassay (ELISA), bioassay/cell-based (ADCC, flow cytometry), or device functionality (BL/GF) methods
• Ability to work in a team environment, and strong verbal and written communication skills
• Demonstrated computer skills; experience using MS Office and other data analysis software and related applications

Desired Skills

• Prior experience in a Quality Control GMP laboratory and/or regulated industry environment and knowledge of cGM