Principal Engineer - Devices
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration through scientific research. Here, employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.
The successful candidate will be able to lead a cross functional team, and direct the design, development and implementation of new drug delivery devices. The candidate will work with her/his team to ensure that device design, component selection, manufacturability and testing meet the product needs. This person will regularly interface with staff and leaders in Device Development, Quality, Regulatory Affairs, and across biologics product development. He/She should be capable of presenting at senior management meetings, health authority meetings and audits. He/she will be able to lead technical development with external development partners and component suppliers. In addition He/She will drive problem solving activities using state of the art tool such as DMAIC, DFFS, DOE, Monte Carlo Simulation, Probabilistic Design.
Major Duties and Responsibilities (including supervising others):
- Lead cross functional team in the selection, development, scale up and commercialization of drug delivery devices for the MedImmune pipeline
- Management of direct reports (engineers and/or scientists), including providing technical and leadership guidance and mentorship
- Contribute to building the departmental combination product development capability by applying and maintaining a high level of knowledge and expertise
- Influence and educate cross-functional stakeholders and leaders on device development and commercialization best practices
- Establish a close working relationship with and provide effective oversight of suppliers and manage technical aspects of external collaborations
- Drive a Quality mindset and ensure that work is performed in accordance with appropriate quality requirements and compliance standards (e.g. risk management, Design Controls, ISO standards etc.)
- Contribute to regulatory filings
- Ability to develop and implement best practices / business processes
Minimum of a Bachelor's Degree required
Advanced degree in Engineering or equivalent preferred
10+ years of experience managing combination product development or device development projects
Other Skills and Qualifications:
In addition, the candidate should have excellent leadership skills to lead a cross functional team and ensure success of the project. Experience in working with external companies is also highly desirable. A proven track record of working effectively in a matrix organization with a highly cross-functional and collaborative environment is a must. Excellent communication skills are required.
Next Steps – Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
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.