Associate Scientist, Extractables and Leachables, Late-Stage Fo
AstraZeneca

Job Info

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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.

The annual base salary for this position ranges from $66,000 to $100,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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.

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