Sr Manager - Design Control, Drug-Device Combination Product - Durham, NC - Operations
Do you enjoy supporting the technical development of inhalation devices for respiratory drug delivery within a company that follows the science and turns ideas into life-changing medicines? If so, then the Sr Manager - Design Control, Drug Device Combination Product - in Durham, NC might be the position for you!
Be part of leading our Development function at an exciting time of growth and evolution. We pioneer new approaches and processes across our sites, empowering our teams to foster a Lean mindset and sustainable practices. Every change we make is to deliver better outcomes for our patients.
We are inspiring and credible leaders, ensuring everyone on our site has a platform and opportunity to speak up and share their ideas.
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 create 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 is in Product Development and supports AstraZeneca’s Inhalation mid-to late-stage product development activities. The ideal candidate will support the technical development of inhalation devices for respiratory drug delivery, from early phase activities up to commercialization, by leading the design controls activities and the corresponding documentation in compliance with current drug-device combination product regulatory standards. In addition to outstanding documentation and interpersonal skills, a strong technical engineering background, as well as regulatory knowledge in medical devices, is crucial.
What you will do:
Lead design control activities for inhalation drug-device combination product development to ensure compliance with 21 CFR 820. Requires good leadership and collaboration skills.
Provide direction and support for the optimal design of complex, large-scale systems through consideration of the system as a whole, rather than individual components of the system.
Work and communicate with cross-functional teams to define design control strategy and drive design control deliverables.
Drive and oversee Design History Files for drug-device combination products and medical devices including user requirement specifications, design input requirements, design and development plan, risk management plan, design verification, design validation, and design transfer plans and reports, etc.
Organize, prepare and host design review meetings in order to ensure controlled and documented completion of typical device development stages (Concept Generation, Concept Development, Detailed Design, Design Verification, Design Validation, New Product Introduction/Tech Transfer phase).
Supervise risk management activities along with design and development process, including use, design, and process-related risk evaluations using FMEA methodology, hazard analyses, risk summary reports, etc.
Education/Minimum Years Industry Experience
Ph.D. / 5 years; MS / 10 years; BS / 15 years
Degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a similar applicable discipline
Subject matter expert on inhalation (MDI, DPI) drug-device combination product development
Familiar with ICH guidelines, USP/EP requirements, and FDA/EU guidance on inhalation dosage forms and drug-device combination products
Working knowledge of JMP, and Microsoft Word, PowerPoint, Excel, and Outlook. Ability to operate a PC and sit and stand for extended periods of time.
Working experience in a GMP environment.
Outstanding organizational, planning, and prioritization skills with the ability to multitask and adaptable to synthesize large amounts of information and deliver results despite shifting environment.
Strong analytical problem-solving skills and attention to detail.
Knowledge of statistical analysis tools, especially experimental design and interpretation and multivariate analysis of complex data sets.
Lean experience desired
Experience authoring IND/IMPD/NDA/MAA regulatory filings is desired.
At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.
The challenge to stay ahead in rapidly changing markets is what keeps us driving forward, as we continuously seek new and better ways to deliver medicines all the way to our patients. Our resilience helps us to thrive as we innovate and evolve.
So, what's next?
Are you ready to bring new ideas and fresh thinking to the table? Wonderful! We have one seat available, and we hope it’s yours.
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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.