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Manufacturing Technical Associate - BPD

Location Gaithersburg, Maryland, United States Job ID R-085162 Date posted 06/23/2020

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:
Manufacturing Transfer & Integration is part of the Manufacturing Sciences team – a fully integrated process scale-up and biomanufacturing function based in Gaithersburg, Maryland.  We support our Pilot Plant Facilities, where our dynamic clinical manufacturing team performs bioprocessing operations for novel molecules to support the development of new medicines. As a team, we produce pre-clinical and early through late stage clinical drug products that advance AstraZeneca’s biologics pipeline. 
Our integrated team collaborates broadly across the organization:

  • Partner with technical process development and manufacturing teams during tech transfer activities for each new manufacturing campaign
  • Work with Materials Management team to bring in new raw materials and ensure adequate supply is maintained 
  • Perform non-conformance identification and resolution activities with Quality Assurance
  • Communicate equipment needs to engineering, technical service, and process automation functions to prepare for new processes and operational capabilities

Main Duties & Responsibilities:

  • Author and maintain content in GMP technical documents including Production Records and Standard Operating Procedures (SOPs) to accurately reflect the clinical manufacturing process
  • Collaborate with external functions to manage review and approval processes of technical documents in alignment with dynamic manufacturing schedule
  • Lead simple change control records and minor non-conformance investigations, identify appropriate CAPAs, and ensure on-time closure quality records in Trackwise System
  • Support GMP training administration by entering training data into electronic Learning Management System (eLMS) and assisting with creation and delivery of technical training content

Education & Experience Requirements:

  • Bachelors degree in a scientific discipline
  • 2+ years related GMP experience OR Masters degree in a scientific discipline and 1 year of related experience is preferred

Required Skills:

  • Technical Writing skills and ability to communicate effectively across functions
  • Demonstrated capability to adapt and take initiative to problem-solve creatively, escalating appropriately when needed
  • Scientific curiosity and interest in GMP bioprocess manufacturing

Desired Skills:

  • Troubleshooting of process and equipment issues in biopharma manufacturing facility
  • Knowledge of investigation tools such as 5 Whys and PEMME
  • Experience with GMP systems such as Trackwise or document management systems
  • Ability to map out processes using software like Visio

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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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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Glassdoor logo Rated four stars on Glassdoor

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