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Associate Director – Group Leader, Bioassay Development

Location Gaithersburg, Maryland, United States Job ID R-137029 Date posted 04/05/2022

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:

The successful candidate will manage a team of talented scientists who develop and deliver state of the art, robust and fit-for-purpose biological assays to support progression of products from research to clinical trials. Our scientists execute bioanalytical characterization of AstraZeneca assets including antibody drug candidates, bispecific, and other biologics. We also support regulatory filings for INDs up to and including BLAs.

The successful candidate is independent, self-motivated, and eager to tackle a broad range of responsibilities. This full-time position within the Bioassay, Biosafety and Impurities Department, within Biopharmaceutical Development, is located in Gaithersburg, Maryland.

Main Duties & Responsibilities:

  • Manage a team of scientists in the development, optimization and qualification of a variety of bioassays to support release, stability testing and characterization of biologics such as bi-specific antibodies, antibody drug conjugates (ADC), and inhaled biologics.
  • Serve as technical lead on analytical method development, qualification and life-cycle management
  • Create and manage career development plans for scientists at multiple levels of training and experience, including the development of other managers
  • Serve as a key member of an established leadership team in Bioassay, Biosafety and Impurities Method Development
  • Identify, evaluate and implement cutting-edge technologies to improve the efficiency of in-process, release, and characterization of bi-specifics, ADC and inhaled biologics.
  • Author and review documents including assay development reports, SOPs, assay transfer protocols/reports, CMC sections of regulatory filings, and scientific journal publications.
  • Work in a team setting and interface with different Research and Development departments as well as Departments responsible for late-stage and commercial bioanalytical methods

Education

BS with 15+ years of relevant experience

MS with 13+ years of relevant experience

PhD with 7+ years of relevant experience

Required Skills:

  • The successful candidate has in-depth understanding of bioassay method development, training, tech transfer, and qualification for lot release and characterization.
  • Candidates must have a thorough knowledge of a range of techniques and their applications in assessing cellular signaling, receptor binding, cytokine secretion, cell proliferation, cytotoxicity.
  • Excellent organizational and teamwork skills
  • Strong written and oral communication skills

Experience:

  • Experience managing scientists in CMC analytical and biological assay development, qualification, tech transfer and sample testing
  • Experience with biologics CMC strategy, such as CQA assessment and elucidation of structure.
  • Experience reviewing laboratory procedures, experimental plans, data analysis and reports with keen attention to detail and insight into regulatory implications
  • GMP experience is a plus

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



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.

50056741 E SCGE R&D BioPharmaceuticals

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.