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locationGaithersburg - Maryland (MD),


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:

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:

  • Responsible for interpreting, adapting and translating technical drug development information into coherent procedures/instructions.
  • Leads investigations, drives corrective/preventive actions.
  • Provides technical compliance support, expertise, and training as required.
  • Works in team and matrix-oriented environment with cGMP Manufacturing, Materials Management, Engineering & Automation, Technical Services, CMC Project Management, Process Development, Tech Transfer, and Quality functions.

Education & Experience

  • Education & Experience Requirements:

    BS/MS degree in a scientific discipline preferred, High School diploma with commensurate experience may be considered.

  • BS/MS and 0+ years of experience

Required Skills:

  • Technical writing in a cGMP setting.
  • Strong attention to detail and ability to translate scientific information into executable manufacturing records
  • Ability to manage investigations in a cross-functional setting and develop sound corrective/preventative actions.
  • Capable of identifying areas of improvement and driving change through lean principles
  • Strong collaborative skills to work in a team environment as well as manage their own tasks/workload for on-time delivery.

Desired Skills:

  • Ability to manage change controls and project timelines
  • Quality systems experience in change and document management a plus
  • Able to prepare professional technical and GMP oriented training materials.
  • Experience with material specifications and inventory management systems 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?

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

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AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants. COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation.

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