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Scientist II - BPD

Location Gaithersburg, Maryland, United States Job ID R-091314 Date posted 10/02/2020

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:

This role reports into the Process Engineering and Packaging (PEP) group for drug product process development within the Biopharmaceutical Development (BPR) function in AstraZeneca. The PEP group has accountability for drug product process development, process characterization, combination product assembly development, and packaging science and technology across a broad range of biotech product types and technologies. We support the entire portfolio from Phase 1 clinical trial materials through to marketing application and product launch.

Main Duties & Responsibilities:

1) Leadership: Contribute strategic thinking to drug and combination product development teams by providing knowledgeable advice on design for manufacturing, equipment vendor selection, manufacturing site selection / alternatives, project lead time and budget estimates.  Advise functions and teams on new manufacturing technology selection and development.  Develop risk-based characterization and validation strategies for manufacturing processes.  Propose general working strategies and risk-based project strategies that meet requirements of design control, product quality, cGMP, as well as timeline and budget constraints. 

2) Process Design and Development: Develop manufacturing processes, specify requirements of manufacturing equipment and support equipment design and build, perform process risk assessments such as FMEA, design characterization and engineering studies, develop control strategies, author protocols, technical reports and regulatory filing sections.  Provide technical rigor in design for manufacturing, experimental design, data analysis, and technical writing.  Develop pilot laboratory fill and assembly process capabilities. 

3) Tech Transfer and Validation: Lead late-stage and commercial technical transfers to CMOs and internal facilities.  Organize an internal sending unit team including development functions (device, analytical, packaging, formulation, fill and assembly process SMEs), supply chain, project management and QA.  Ensure correct implementation of control strategies for the drug product and device into manufacturing records. Design and oversee validation activities for equipment, manufacturing processes, and shipping.  Manage timelines and activities internally, communicate goals and oversee successful delivery at the receiving site.  Some travel (5-15 trips per year) in the US and abroad is required. 

Education & Experience Requirements:

Educational requirements include a degree in mechanical, chemical, or pharmaceutical engineering, chemistry, materials science, or a related engineering or pharmaceutical science field.  Typical candidates will have a BS or MS with at least 10 years of experience, or a PhD with at least 4 years of experience.

Required Skills:

  • Biopharmaceutical drug product development for monoclonal antibodies and recombinant proteins
  • Knowledge of formulation and fill-finish unit operations such as freeze-thaw, formulation, filtration, mixing, and aseptic filling.
  • Equipment, Process and Shipping Validation
  • QbD, experimental design, statistics, data analysis
  • Leadership and interpersonal communication
  • Technical writing and documentation

Desired Skills:

  • Combination product development and cGMP regulations
  • Knowledge of assembly, label and packaging processes and equipment
  • Experience with novel and new biotech modalities (mRNA, adenovirus delivery, CAR-T therapies, antibody-drug conjugates, etc.)

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?

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

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