Are you looking to support inhaled drug product development with an emphasis on large molecule biologics using the latest in analytical methodologies? Then AstraZeneca's Associate Scientist, Analytical Scientist in Durham, NC, may be for you! Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast-paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing. Join us at our Durham, NC Research Triangle Park site, the leading center of innovation in the Southeast!

The Associate Scientist will develop stability indicating assays and rapid content assays supporting in a cGMP environment.

What you will be doing but not limited to:

Validation of analytical methods in accordance with ICH guidelines, conducting routine testing supporting stability studies, writing validation reports for submission in regulatory documents, trouble-shooting laboratory equipment, conducting new formulation feasibility/stability studies

• Design experiments and conduct analytical experimental work related to advancing IPD product quality and performance.

• Develop and validate stability indicating analytical methods to support pMDI and DPI development of inhaled biologics drug product platforms using HPLC, UHPLC, and CE, in combination with various specialized detection schemes such as UV-Vis, FLD, MALS, and DLS, validate rapid assays used in support of aerosol performance testing for novel DPI formulations.

Education/Experience:

• BS, MS, or PhD in Chemistry, Pharmaceutical Sciences or a similar applicable field.

• PhD – 0+ years, MS – 4+ years, BS – 8+ years of relevant industry experience.

• Knowledge in LC, GC, and/or in MS.

• Knowledge in analytical instrumentation, trace analysis of impurities, degradation products, and/or in extractables/leachables.

• Experience with controlled documents, documents for regulatory submissions and knowledge of GMP requirements.

• Knowledge of relevant ICH, USP, EP, and FDA guidance documents as well as cGXPs..

Desired:

• Minimum of six (6) years of proven experience in testing inhalation products preferred, especially MDIs, with a variety of active pharmaceutical ingredients at different stages of development.

• Project leadership experience is desired.

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, groundbreaking cutting-edge methods and bringing unexpected teams together. Come join us.

Next Steps – Apply today!

Are you ready to bring new ideas and fresh thinking to the table? We have one seat available, and we hope it’s yours. Curious to know more, then please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well-qualified for this opportunity. Know someone who would be an excellent fit, please share this posting with them.

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• About Operations https://www.youtube.com/watch?v=gak5Ham8oUw

Date Posted

Closing Date

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.