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, 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

This role is in Product Development and supports AZ’s pressurized metered dose inhalers (MDIs) mid to late stage product development activities.  The ideal candidate will have development experience with drug-device combination products, including inhalation products, and a working knowledge of medical device design controls.  

Responsibilities:

• Lead technical development teams with focus on product development, characterization, root cause analysis and risk mitigation
• Lead the development and execution of complex technical protocols for the development of MDI drug products using both internal and external resources
• Author protocols and development reports as well as general development reports bringing together data from multiple studies and disciplines into coherent development history summaries. Author finished product or CCS/formulation components specifications
• Lead the development of new device technology and advancement of the current container closure system.
• Organize and interpret large data sets and communicate data impact or value to senior R&D leadership
• Collaborate internally with AZ analytical sciences, MDI manufacturing, formulation sciences, quality assurance, and regulatory affairs to effectively deliver on responsibilities
• Authors sections of regulatory documents (e.g., DMFs, INDs, NDAs, etc) based on the design / results of protocols designed through project teams.  Works within the timelines set forth within the regulatory and corporate timelines for US and ROW submissions. Participate/lead the interactions with Health Authorities for regulatory meetings.
• Effectively plan, summarize and communicate technical development of pharmaceutical products within and outside the AZ organization
• Contribute/lead to drug product or CCS related investigations to determine root cause to atypical results.  Work closely with QA, analytical and manufacturing staff as well as outside resources ( e.g., vendors) to meet this goal. Communicate observations / make recommendations to senior staff which may eliminate or reduce re-occurrence. 
• Maintain lab notebook following SOP requirements and keep clear and complete records. Ensure GMP compliance where necessary.

Qualifications:

Education:

• PhD – 0+ years, OR
• MS – 4+ years, OR
• BS – 8+ years of relevant industry experience.
• Degree in Pharmaceutical Sciences, Chemical Engineering, Mechanical or Biomedical Engineering, Chemistry, Material Sciences or a similar applicable discipline.

Required:

• Inhalation drug delivery experience is required.
• Knowledge and experience in how suspension MDI formulations interact with the valve, can, and actuator is required.
• Ability to travel of 5 - 10% of working time required.
• Ability to operate a PC and sit and stand for extended periods of time. 
• Excellent written and verbal communication skills.

Preferred:

• Working knowledge of JMP, and Microsoft Word, Powerpoint, Excel and outlook (statistical) preferred.
• Working knowledge of analytical methods, MDI formulation and container-closure systems, and manufacturing processes preferred.
• Familiar with ICH guidelines, USP/EP requirements and FDA/EU guidance on inhalation dosage forms preferred.
• Experience authoring IND/IMPD/NDA/MAA regulatory filings is desired.
• Knowledge of statistical analysis tools, especially experimental design and interpretation and multivariate analysis of complex data sets preferred.
• Know how/when to apply organizational policy or procedures to a variety of situations required.
• Working experience in a GMP environment preferred.

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.

Date Posted

Closing Date

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.