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Specialist (Clinical Biologics)

Lieu Gaithersburg, Maryland, États-Unis Job ID R-162438 Date de publication 03/24/2023

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 place for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. We're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity. Working here also 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 groundbreaking technology and lab spaces, all designed to inspire collaboration and multi-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.

Summary of the Role:

As a Specialist in the clinical production team within Biopharmaceutical Development, you’ll build broad knowledge of bioprocessing in a cGMP environment to launch your career in the biopharmaceutical industry. In this role, you will take an adaptable, science driven approach to everything you do. You will become an integral part of process development, accelerating product candidates into the clinic, and gaining knowledge and experience in cell culture, purification and critical support activities. Under the supervision of highly trained personnel, you will gain the process knowledge and skills to perform large scale clinical development activities through hands-on training. You will join a driven team that works together in a world class biopharmaceutical company that is driving innovative innovation in the industry.

Main Duties & Responsibilities:

1st Shift (Monday-Friday; 6:30am-3:30pm) or 2nd Shift (Monday-Friday; 2pm-11pm)

  • Serves as the “Subject Matter Expert” in unit operations to improve quality, ensure safety, and drive process efficiency and accuracy

  • Support process improvement initiatives and authors or revises standard operating procedures accordingly.

  • Operates and serves as a trainer for operation of manufacturing equipment such as: incubators, stainless steel and disposable single-use bioreactors, depth filtration skids, chromatography skids, single-use mixers, centrifuges, cleaning/sanitization of equipment, washers, autoclaves, tanks and in-process testing instruments.

  • Monitors process parameters, contributes to investigations, troubleshoots during processing, and recommends potential solutions.

  • Reviews executed Production Records for accuracy and completion 

  • Ability to use MS Office tools and AstraZeneca enterprise systems 

Education & Experience Requirements:

Education: Bachelor’s degree in a science related field

Experience: Bachelor's degree and 4+ years of relevant experience

Required Skills:

  • Proficient in cell culture operations such as biosafety cabinet operation, cell banking, bioreactor operations (e.g. tabletop bioreactor and single use bioreactors), aseptic technique, and centrifuge harvest operations.

  • Ability to work with others in a team environment and lead a team of peers

  • Proficient in raw material weigh out and media/buffer preparation

  • Proficient in the operation of all area specific production equipment such as column chromatography operations, tangential flow filtration, formulation and column packing

  • Proficient in basic analytical testing (e.g.  protein concentration, osmolarity, pH, etc.)

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 groundbreaking 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?

Our Social Media:

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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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