At AstraZeneca, we turn ideas into life-changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Scientist, Analytical Sciences, Inhalation Product Development in Durham, NC, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. 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.

Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK

The Scientist, Analytical Sciences, Inhalation will be responsible for developing stability-indicating assays and rapid content assays supporting inhaled drug product development with an emphasis on large molecule biologics using the latest in analytical methodologies in a cGMP environment.  In addition, this position will be responsible for the 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.  

Duties and Responsibilities: 

• Under minimal guidance, design experiments and conduct analytical experimental work related to advancing IPD product quality and performance.
• Able to identify aberrant data and effectively communicate observations to project management.
• 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. 
• Develop and validate rapid assays used in support of aerosol performance testing for novel DPI formulations.
• Develop specialized bioanalytical sample handling and preparation techniques for inclusion in stability-indicating analytical methods.
• Write SOP’s for new bioanalytical instrumentation procured to support the inhaled biologics portfolio.
• Write analytical methods for bioanalytical testing:  SEC, IEC, CE (R/NR), cIEF, CZE, HIC, and A280 content assays.
• Conduct routine testing as part of early phase stability studies for submission in regulatory filings.  
• Prepare technical reports and presentations summarizing scientific data.
• Oversee the maintenance of chromatographic and other laboratory equipment.
• Communicate project status and concerns to management.

Education:

• BS, MS, or PhD in Chemistry or Biochemistry, Pharmaceutical Sciences

Required:

• BS degree - with a minimum of ten (10) or MS degree with a minimum of five (5) years’ experience of PhD degree with a minimum of two (2) years in method development and validation on a variety of small and large molecules and at different stages of development.
• Experience in developing and validating biophysical characterization methods such as cIEF, CGE, using Capillary Electrophoresis (CE).
• Experience with bioanalytical sample handling and preparation techniques.
• In-depth knowledge and experience with chromatographic methods such as HPLC, UPLC, SEC, HIC with a variety of detection techniques such as UV-Vis, Fluorescence, CAD, MALS, and DLS for analysis of proteins or other large bio-molecules. 
• Familiarity with relevant ICH, USP, EP, and FDA guidance documents as well as GMPs in support of pMDI and DPI product testing.
• Proficient in the set-up, use, and troubleshooting of analytical instrumentation and data acquisition software (Chemstation and Empower). 
• In-depth understanding of relevant ICH, USP, EP, and FDA guidance documents supporting BLA’s.
• Must have prior experience testing in a GMP environment.
• Must be able to effectively communicate verbally and through technical writing (protocols, reports, methods, and documentation of laboratory experiments).

Preferred:

• Experience in the development and validation of DPI (dry powder inhaler) methods such as delivered dose uniformity (DDU) and aerodynamic particle size distribution (NGI) is a plus.

Next Steps – Apply today!

To be considered for this exciting opportunity, 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.  If you know someone who would be a great fit, please share this posting with them.

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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 authorization and employment eligibility verification requirements.