AstraZeneca Durham has expanded and strengthened its respiratory products portfolio, delivering approvals and launches for multiple global inhalation products, with a robust pipeline in development. Our mission, through dedication to creating a culture of inclusion and teamwork, is to develop innovative therapeutics for respiratory diseases and conditions including asthma and COPD. . This site is responsible for the product, device, process, and analytical development of new inhalation products in the AZ portfolio. The site also manufactures and packages clinical supplies to meet clinical trial demands. Join us in Durham, NC, which is situated in Research Triangle Park; the leading center of innovation in the Southeast!
This role will support AstraZeneca's pMDI products from product development to commercial launch.
Lead technical development teams with a focus on product development, characterization, root cause analysis, and risk mitigation
Provide guidance and oversee the development and execution of complex technical deliverables 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
Foster and lead collaboration internally with analytical sciences, MDI manufacturing, quality assurance, and regulatory affairs to effectively deliver on product development goals.
Author relevant sections of regulatory filings
Mentor and manage others working on drug development
Experience with leading cross-functional teams to effectively deliver on product development goals while also understanding and being able to articulate risks for projects.
Minimum Requirements:
Bachelor’s degree in a scientific field.
Minimum of 10 years of pharmaceutical development with a strong background in technical project development, project delivery, and leadership, OR Ph.D. - 4+ years, or MS – 6+ years.
Development experience with drug-device combination products, including inhalation products, and a working knowledge of medical device design controls.
Strong problem-solving and communication skills with the drive and leadership qualities needed to deliver on project goals.
Preferred Requirements:
Knowledge and experience in how suspension MDI formulations interact with the valve, can, and an actuator is desired
Experience authoring US and international regulatory documents is desired
