Engineering Manager, Device Functionality & Safety Lab - BPD
Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
About AstraZeneca in Gaithersburg, MD:
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.
Summary of the group:
Device Development provides combination product expertise to the development of drug-delivery parenterals for the expanding Astra Zeneca pipeline. Our group consists of people with a diverse range of technical backgrounds including device engineers, human factors engineers, people with equipment and test method development expertise, design controls skills, risk management skills and more. Our work spans from early concept development to prototyping through to clinical introduction and commercialization. Currently, we need an experienced person to lead our device characterization and testing group to ensure characterization and verification of devices meets design requirements, quality standards and health authority expectations.
Main Duties & Responsibilities:
The candidate will be responsible for lead a team in the following activities:
- Device and combination product characterization and testing that meets quality standards and health authority requirements for the breadth of AZ parenterals molecules in the development pipeline
- Device functionality and safety test method development and validation
- Test equipment expertise to enable new and existing test strategies
- Health authority submission writing
- Transfer of methods to network sites
- Collaboration across Astra Zeneca with parenterals and device colleagues
- External collaboration across industry to be knowledgeable of and influence combination product development best practices
Education & Experience:
Bachelor's degree in Engineering or Science. Master's degree preferred.
Minimum of 10 years of related experience with at least 5+ years experience in combination product development.
- Working knowledge of relevant combination product designs, methods, and equipment. Understanding of statistical data analysis and testing strategies. Deep understanding of design controls, and risk management regulations, standards, and guidances for medical devices and combination products
- Proven ability to clearly communicate effectively and work with direct reports, peers and senior leaders
- Demonstrated team management, decision making, presentation, and organization skills
- Strong interpersonal skills and the ability to collaborate actively and proactively with others in a cross-functional team
- High level of initiative and ability to work independently
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what’s next!
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
Where can I find out more?
Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd
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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.