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)

Main Duties & Responsibilities

The successful candidate will be responsible for working collaboratively in the Analytical Sciences GMP laboratory team, to ensure that release and stability testing of clinical trial material is performed according to international regulatory and AstraZeneca requirements.

Responsibilities:

• Work as part of a team and contribute to design and/or execution of analytical studies to determine the quality and stability of drug substance and drug products.
• Participate in analytical method qualification and technical transfer activities.
• Execute analytical testing, data review and interpret results according to written procedures and communicate progress to immediate peer group and supervisor
• Author, revise and/or review SOPs, protocols, reports and other relevant documentation
• Independently perform sample management responsibilities such as sample receipt, inventory and distribution between R&D departments to enable CMC activities.
• Maintain laboratory and equipment in accordance with written procedures.
• Perform analytical quality investigations, as needed.
• Participate in cross-functional teams and process improvements
• Ensure that work is performed in accordance with appropriate safety and cGMP standards

Education & Experience Requirements:

Education:

Associate Scientist - A bachelor’s or master’s degree or equivalent in biology, chemistry, or related field.

Scientist

Education: A bachelor’s or master’s degree or equivalent in biology, chemistry, or related field.

Experience: B.S. with 5+ years of experience or M.S. 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 cGMP and regulatory requirements for biologic products.
• Experience with Labware Laboratory Information System (LIMS) and training on automated sample management equipment.
• Prior experience with stability sample handling (aseptic aliquoting and sample distribution) in GMP environment.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next!

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

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

Date Posted

07-Mar-2024

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.