Senior Scientist, Late Stage Formulation Sciences - BPD at AstraZeneca in Gaithersburg, Maryland

Posted in Other 22 days ago.

Job Description:

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:

As a member of Biopharmaceutical Development, the Late-Stage Formulation Sciences group within the department of Dosage Form Design and Development is on a mission to develop extraordinary products through excellent science, nimble execution, and compassion for patients and those who touch our products. In Late-Stage Formulation Sciences, we develop and characterize intended commercial formulations and finished dosage forms to deliver high quality biologics to the market for patients. We develop robust formulations, Drug Products, and product control strategies to ensure approval of marketing applications for product commercialization and launch.

Main Duties & Responsibilities:
  • Provide scientific and matrix leadership for late-stage formulation development of biologics
  • Responsible for project decisions and deliverables, scientific and organizational objectives.
  • Lead development of intended commercial formulations and drug products to advance late-stage portfolio, and life cycle management of commercialized products.
  • Author and review marketing applications and support regulatory responses to approval.
  • Interface with stakeholders to ensure seamless end-to-end product development. Drive scientific initiatives and innovation through personal leadership.
  • Design and implement scientific and business strategies integrated across biopharmaceutical development.

Education & Experience Requirements:

B.S. in chemistry, biochemistry, pharmaceutical sciences, engineering, applied sciences, or related field with 15 years of experience, M.S. with 13 years, or Ph.D. with 7 years.

Required Skills:
  • In-depth knowledge of formulation and biopharmaceutical development, protein biochemistry and degradation mechanisms, biopharmaceutical manufacturing processes, combination drug products, and/or analytical and comparability testing strategies is required.
  • Direct experience with CMC leadership, formulation characterization, control strategy, in-use compatibility, quality risk management, and/or CMC regulatory guidance and marketing applications is critical
  • Demonstrates strong scientific knowledge and thinking to navigate project and the business forward.
  • Effectively and efficiently explains and presents complex scientific concepts to diverse audiences.
  • Develops creative solutions to complex problems leveraging scientific and business knowledge, but likewise proficient at anticipating and heading off potential issues.
  • Excels at making good decisions and priority setting.

Desired Skills:
  • Knowledge with the development and commercialization of antibody-drug conjugates and/or novel biologic modalities is a definite plus.
  • Experience with study design (Design of Experiment) and statistical data analysis, model building, robustness optimization and data simulation using JMP or Minitab software is highly desired.

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 recognizing their potential. Join us on our journey of building a new kind of organization 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?

Check out our landing page for more information on our BPD group

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