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Manager/Sr. Manager, Manufacturing Sciences Tech Transfer - BPD

Location Gaithersburg, Maryland, United States Job ID R-093858 Date posted 11/24/2020

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:

The Manager, R&D will lead the Manufacturing, Transfer and Integration team within the Manufacturing Sciences (MS) organization. The individual will represent MS and provide scientific and tactical leadership in support of new and resupply manufacturing campaigns and new technology implementation at the Gaithersburg Pilot Facility. The position manages tech transfer project deliverable timelines, deviation/investigations, metrics/reporting and requires close partnership with groups including but not limited to Biopharmaceutical Development, Manufacturing Sciences, and Quality Assurance. The individual must possess the ability to multi-task and manage frequent changes in scope, timelines and priorities.  Additional job expectations include critical review of data, critical thinking and creativity in solving problems as well as data management and documentation. This position also includes direct reports and may have additional matrixed reporting responsibilities as needed.

Main Duties & Responsibilities:

  • Manages all tasks and resources required for new product introductions, batch record and creation/revision/approval for new & resupply manufacturing campaigns.
  • Manages all tasks and resources required for non-conformance investigations and technical risk assessments.
  • Leads complex investigations with demonstrated scientific and technical writing abilities, ensuring product quality and patient safety of affected batches.
  • Works cross functionally with the all aspects of the organization to remediate events/issues and identify GMP phase appropriate CAPAs necessary to close out the investigation.
  • Reviews and approves documents (MPR, SOP, SPR, MS, BOM) authored by junior staff.
  • Initiates and leads presentations/discussions of technical information concerning specific projects, schedules, continuous improvement initiatives, lean manufacturing initiatives, etc.

Education & Experience Requirements:

Degree in Engineering or Life Sciences.

Bachelor’s degree and 10+ years experience or Master’s degree and 8+ years experience in biotech/pharmaceutical industry. Relevant industry experience in biologics - preferably in process development, tech transfer, and/or cGMP manufacturing. Experience managing people and directly and/or within a matrix organization. Experience in FMEA, QRM, LEAN and/or Six Sigma preferred.

Required Skills:

  • Has in-depth knowledge of multiple disciplines and technical areas. 
  • Develops solutions to complex problems requiring ingenuity and creativity. 
  • Displays knowledge about how the organization works and solves problems through formal channels and informal networks.
  • Comfortable with ambiguity.
  • Works independently without appreciable direction.
  • Ability to build effective teams and foster collaborative relationships.

Desired Skills:

Experience in FMEA, QRM, LEAN and/or Six Sigma

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.