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Standort: South San Francisco, Kalifornien, USA
Anzeigen-ID: R-051238
Veröffentlichungsdatum: Oct. 18, 2019

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.

Position Summary:

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

Education

Minimum of a Bachelor's Degree required

Advanced degree in Engineering or equivalent preferred

Experience:

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!

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.

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 lawAstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Principal Engineer - Devices
Wissenschaftsbereich

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