Associate Scientist, Late-Stage Formulation Sciences

The Late-Stage Formulation Sciences (LSFS) Group is responsible for development of intended commercial formulations to advance AstraZeneca’s late stage biologics portfolio, and the life cycle management of commercialized products. The group plays an integral part in the design and development of patient centric drug products.As a part of Biopharmaceutical Development, the Late-Stage Formulation Sciences group, within the department of Dosage Form Design and Development, is on a mission to develop extraordinary products through excellent science, forward-thinking execution, and compassion for patients and those who touch our products. We develop and characterize intended commercial formulations and finished dosage forms to deliver high quality biologics to the market for patients. We develop robust formulations, Drug Products, and product control strategies to ensure approval of marketing applications for product commercialization and launch.What you’ll do:Design and execute experiments for extractables and leachables studies as part of biologics formulation development.Exercise technical discretion and scientific rigor in experimental protocol design, data analysis, and results interpretation.Work with contract testing laboratories and contribute to implementation of extractables and leachables testing strategy.Participate in formulation development activities for late-stage assets.Present findings in departmental and inter-departmental meetings and prepare technical reports.Education:BS in Chemistry, Biochemistry, Pharmaceutical Sciences, Bioengineering or a related field with 0-2+ years of laboratory-based experience.Required Skills:Experience with small-molecule analytical techniques for detection, identification, quantitation, and characterization is a must.Hands-on experience with gas and liquid chromatography, and mass spectrometry is strongly preferred.High degree of self-motivation and drive for results are critical.Desired Skills:Experience with Drug Substance and Drug Product formulation risk assessments and characterization studies a plus.Experience with analytical method validation, formulation and biopharmaceutical development, characterization, control strategy, quality risk management, and/or CMC regulatory guidance and BLA filings is desired.Skills leading, planning, and executing complex projects on tight timelines are a plus.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.

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