Downstream Team Lead/Manager, Clinical Biologics

Gaithersburg, Maryland

This job has expired.

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 Sciences team, based in Gaithersburg, Maryland, is a fully coordinated process scale-up and cGMP biomanufacturing function. At our Pilot Plant Facilities, our multifaceted clinical manufacturing team performs bioprocessing operations for novel molecules to support the development of new medicines. We produce pre-clinical and early through late stage clinical drug products that advance AstraZeneca's biologics pipeline. Our coordinated team collaborates with our counterparts in technical process development; leads and assures the supply of raw materials; performs non-conformance identification and resolution activities; and provides engineering, technical service, and process automation functions.

Main Duties & Responsibilities:

• Participates and/or Lead initiatives involving individuals from cross-functional teams to solve complex issues. Interacts regularly with subordinates, other production sub-groups, Process and analytical development, functional area peers, and area management.

• Serves as product/process or equipment lead/champion in the introduction and implementation of new equipment, innovative technologies, and novel products from concept through bench scale, scale-up areas and cGMP manufacturing.

• Ensuring operational efficiency including adequate training and qualification of personnel.

• Facilitates and/or contributes to standard operating procedures as well as strategy development such as lean manufacturing used to improve process performance.

• Regularly works on non-routine manufacturing assignments where the ability to assess/analyze identifiable factors, situations and/or data is required. Works under minimal direction to resolve daily operational issues and implement business solutions that may span across multiple functional areas.

Education & Experience Requirements:

• Bachelor's Degree in the sciences or engineering and 5+ plus years' experience in a Downstream / Purification manufacturing environment, preferably including 2+ years supervisory experience.

Note: This is a 2nd shift position, M-F, 2-11 pm

Required Skills:

• Large scale downstream purification hands on operation and troubleshooting.

• Demonstrated knowledge of downstream unit operations such as Chromatography, Column Packing, Ultrafiltration / Diafiltration, Nanofiltration and Bulk Fill.

• Demonstrated knowledge of GMP manufacturing principles and its application

• Run time data analysis to assess equipment and process performance

• Microsoft Office productivity applications (Word, Excel, PowerPoint, etc.)

Desired Skills:

• Continuous Manufacturing Processing

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 authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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