Manager, Analytical Sciences - GMP Laboratory

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 management of an Analytical Sciences GMP laboratory team, to ensure that release and stability testing of clinical trial material is performed according to international regulatory and MedImmune/AstraZeneca requirements.

This will include:
  • Coordination of GMP testing and analytical tech transfer activities
  • Ensuring the accuracy and integrity of GMP data
  • Developing and managing personnel
  • Providing technical support to team members and troubleshooting
  • Representing Analytical Sciences during audits and meetings with external partners
  • Leading and/or participating in process improvement activities.

Education & Experience Requirements:

Education : A bachelor's, master's or Ph.D. degree or equivalent in chemistry, biochemistry or related field.

B.S. with 10+ years of experience, M.S. with 8+ years of experience, or Ph.D. and some experience preferred.

Required Skills
  • Prior experience in a Quality Control or GMP testing laboratory supporting clinical development of biologics and knowledge of cGMP and regulatory requirements for biologic products.
  • Expertise with immunoassay (ELISA) methods, and residuals (DNA, HCP) testing analytical methods for analysis of well-characterized biologics. Familiarity with other analytical lot release/stability methods such as bioassay, chromatography (SEC, IEX), electrophoretic (cIEF, CE-SDS), device functionality (BL/GF), or compendial methods (appearance, KF, CCI, pH) is also desirable.
  • Prior experience with method transfer and qualification/validation in a GMP environment
  • Demonstrated ability to lead and develop staff members.
  • Excellent oral and writing skills. Ability to work in a team environment.

Desired Skills
  • Prior experience implementing operational excellence or continuous improvement methodology in a laboratory testing environment
  • Prior experience with CMC development for clinical stage biologics and authoring of regulatory submissions.

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?

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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 authorisation and employment eligibility verification requirements.

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