Senior Scientist - Analytical Science

Join us at AstraZeneca in Research Triangle Park, North Carolina, US as a Senior Scientist supporting Inhalation Product Development. This is an exciting opportunity to be an analytical lead on projects and provide technical support for AstraZeneca’s inhaled product pipeline. We are looking for an energetic, focused individual with a can-do attitude and strong problem-solving and data analytics skills. 

Accountabilities:

Inhalation Product Development (IPD): We are currently seeking an analytical scientist with experience in Inhalation Product Development. The successful candidate will be responsible for methods optimization and development, targeted analytical testing and particle characterization to support investigations and troubleshooting of OOS/OOT results, and support of quality events (deviations, change controls).    The selected person will also hold shared responsibility for method transfers to 3rd parties and select outsourced stability and drug product characterization programs for AZ-IPD-NC.  In depth knowledge of stability regulations/guidances (ICH, WHO, ASEAN) and use of predictive science tools for shelf life and specification setting is preferred.  •He/she/they must provide leadership to project teams in the stability design and analytical development of drug products, and exhibit success in bringing together experts for successful project decision-making.    Preference will be given to candidates that also have experience in inhalation product testing, method development/validation/transfer and analytical instrument qualification to support AstraZeneca’s inhaled product pipeline.  The ideal candidate will be energetic, focused, with a can-do attitude and strong problem solving and data analytics skills.  We are looking for leadership in problem-solving to improve organisational effectiveness and impact a great place to work.

Essential Skills/Experience:
- MS – 2+ years, BS – 5+ years of relevant industry experience.  
- Degree in Analytical Chemistry, Pharmaceutical Sciences, Engineering or a similar applicable discipline.
- Proven experience of leading technical packages for development of inhaled drug products.
- Demonstrated application of ICH requirements for stability, with experience managing analytical and/or stability programs at CROs/CMOs.
- Separation science expertise and practical/hands-on analytical method development and validation (UPLC, HPLC, GC, CE, novel separation technologies) including use of in-silico chromatographic method development software.
- Expert knowledge of software and systems or data analysis, data visualization, presentation, expiry setting (e.g. JMP, Minitab) and proficiency in writing technical documents.
- Background working in a laboratory within data integrity or GxP/GMP requirements Experience with managing Change Controls, Deviations, Lab Investigations, Root Cause Analysis, Data Integrity improvements.

Desirable Skills/Experience:
- Expert understanding of Industry guidance around drug product development.
- Track record of driving scientific projects and business cases.
- Application of predictive modeling tools in drug development.
- Experience with bioanalytical assays for large molecule characterization is a plus (SEC, IEC, HIC, etc…) under cGMP.

At AstraZeneca's Operations function, we are pioneering new approaches and processes across our sites. We empower our teams to foster a Lean mindset and sustainable practices. Every change we make is to deliver better outcomes for our patients. We are adaptable and agile, open to others' views and draw on the diverse expertise of our teams. We are inspiring and credible leaders, ensuring everyone on our site has a platform and opportunity to speak up and share their ideas. We are the champions of Lean, ensuring our teams understand and embody the benefits it can bring. Our work helps give people with diseases a fighting chance. Every day is a challenge but that's what keeps us going.

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