Associate Scientist/Scientist (Cell Therapy)

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 place 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 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 sits within the BioPharmaceutical Development (BPD) group and is responsible for analytical testing and 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, device functionality methods and cell therapy.

This position will support the Cell Therapy functional area directly within the Analytical Sciences GMP group.

Main Duties & Responsibilities:

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

• Perform analytical testing and data review for lot release and stability programs according to written procedures

• Participate in analytical method qualification/tech transfer activities

• Work as part of a team and contribute to design and/or execution of analytical studies to determine the quality and stability of drug products

• Author, revise and/or review SOPs, protocols, reports and other relevant documentation

• Maintain laboratory and equipment in accordance with written procedures

• Train junior laboratory personnel and troubleshoot methods and experiments, as needed

Education & Experience Requirements:

Education: Bachelor’s or Master’s degree in biological sciences, chemistry, biochemistry or related field.

Experience:

Associate Scientist: Bachelor’s with 1+ years of experience or Master’s with 0+ years of experience

Scientist: Bachelor’s with 5+ years of experience or Master’s with 2+ years of experience

Required Skills:

• Expertise with methods and techniques for analysis of cell therapy products, such as: Flow Cytometry, ELISA, qPCR, dPCR, cell culture, cell count and viability measurement and cytotoxicity assays.

• Prior experience in a Quality Control or GMP testing laboratory and knowledge of cGMP and regulatory requirements for cell based products, particularly stem cells and/or CAR T-cells.

• Excellent interpersonal, verbal and written communication skills.

• Ability to work collaboratively as part of a high performing team.

Desired Skills:

• Prior experience performing/managing analytical testing of multiple products with short turn-around times.

• Prior experience with method transfer and qualification/validation in a GMP environment.

• Experience with Labware Laboratory Information System (LIMS) and training on automated sample management equipment.

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 groundbreaking 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 two seats available, and we hope one of them is yours.

Where can I find out more?

Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd

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