Senior Specialist Clinical Biologics

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 Manufacturing Transfer and Integration (MTI) team is an integral part of the overall Manufacturing Sciences group in the clinical development and manufacture of medicines within the AstraZeneca Supply Biologics organization. The MTI group supports batch record generation, investigations, tech transfer, manufacturing floor support, and various other critical functions.

Main Duties & Responsibilities:
  • Interpret, adapt and translate technical drug development information into coherent procedures and instructions.
  • Lead investigations and drive corrective and/or preventive actions.
  • Provide technical compliance support, expertise, and training as required.
  • Work in a matrix-oriented team environment with cGMP Manufacturing, Materials Management, Engineering & Automation, Technical Services, CMC Project Management, Process Development, Tech Transfer, and Quality functions.

Education & Experience Requirements:

Degree in a scientific field with 10+ years' experience in a cGMP environment with BS, or 8+ years' experience in a cGMP environment with MS.

Required Skills:
  • Previous experience as author of documents including complex Master Production Records (MPR's), Solution Preparation Records (SPR's) and other master specifications for raw materials to accurately reflect manufacturing process
  • Track record of leading manufacturing readiness activities for complex tech transfers including training junior staff on technical writing and translation
  • Hands-on review and approval of documents for technical accuracy and quality assurance
  • Experience as lead investigator for complex non-conformances including leading Material Review Board meetings.
  • Ability to represent Manufacturing Sciences Organization in cross-functional forums including internal and agency audits/inspections
  • Capable of identifying areas of improvement and driving change through lean principles

Desired Skills:
  • Demonstrated ability to prepare or commission graphics and illustrations to elaborate on or complement technical writing.
  • Author aseptic qualification/media simulation protocols, shipping studies, container closure studies, and other process validation documents for clinical manufacturing
  • Apply knowledge of technical theories and principles on a broad base where analysis of situations or data requires an in depth evaluation of various factors
  • Successfully work independently as well as in a team environment, balancing multiple tasks and a diverse workload for on-time delivery
  • Collaboration experience with senior internal and external personnel on significant matters often requiring coordination between organizations
  • Ability to identify and troubleshoot complex problems, providing suitable solutions, while driving process excellence and continuous improvement initiatives

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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