Associate Scientist, Analytical Sciences, Inhalation Product Development, Durham, NC - Global Operations
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 an Associate 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 Associate Scientist will be responsible for supporting extractables and leachables (E&L) projects by conducting material, component, and drug product characterizations/investigations and managing outsourced activities.
- Design E&L testing and conduct analytical work related to advancing AstraZeneca product quality and performance.
- Provide support on E&L projects outsourced to CROs.
- Identify aberrant data and communicate effectively to study management, propose appropriate investigational plans, and document the process appropriately.
- Interpreting mass spectral data for structural elucidation.
- Identify and propose analytical equipment to meet defined needs.
- Under general guidance, develop and implement appropriate methods and standard operating procedures for E&L.
- Prepare/review technical reports to summarize data and document experimental conclusions.
- Evaluate data for trends indicative of product performance, method performance, or analyst performance.
- Under general guidance, interface with contract laboratories and research organizations.
- Under guidance, participate in the development of regulatory submissions.
- BS, MS, or PhD in Chemistry, Pharmaceutical Sciences: PhD (0+ years), MS (4+ years), BS (8) years of relevant industry experience.
- Minimum of four (4) years experience in pharmaceutical development testing inhalation products preferred, especially MDIs, with a variety of active pharmaceutical ingredients at different stages of development.
- In-depth knowledge in one or more relevant fields: LC, GC, and MS.
- In-depth knowledge in at least one of the following areas: analytical instrumentation, trace analysis of impurities, degradation products, and 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 GMP in support of E&L testing of inhalation products
- Must be able to effectively communicate verbally and through technical writing (documentation of laboratory experiments).
- Proficient in the set-up, use, and troubleshooting of analytical instrumentation and data acquisition software (Chemstation, Mass Hunter, Xcalibur, and Empower).
- 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).
- Minimum of four (4) years of experience in testing inhalation products preferred, especially MDIs, with a variety of active pharmaceutical ingredients at different stages of development is preferred.
- Project leadership experience is desired.
Next Steps – Apply today!
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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 authorisation and employment eligibility verification requirements.