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Location:
San Francisco, California, United States
South San Francisco, California, United States
Job reference: R-051261
Posted date: Jun. 04, 2019
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If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.  Here at MedImmune, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.

MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

The successful candidate will lead or make strong technical contributions within cross functional combination product development teams and/or to complex technical development and problem-solving projects. The candidate will be responsible for successful completion of design, development and commercialization deliverables and ensuring that device design, component selection, manufacturability and testing specifications and methods meet product needs.  To be successfully the candidate must effectively interface with staff and leaders in Device Development, Quality, Regulatory Affairs, Drug Development, Process Engineering and across other areas of Biologics Product Development and Astra Zeneca.  Strong communication skills are required including succinct and effective presentation of technical and non-technical materials during meetings with company Senior Management / Leaders, health authorities, audits and other internal and external stakeholders. The candidate must lead technical development with external development and commercialization partners and component suppliers and problem-solving activities using state of the art tools and techniques such as DMAIC, DFFS, DOE, Monte Carlo Simulation, Probabilistic Design, etc.  Development and commercialization must be conducted in compliance with applicable processes / procedures, standards and regulations including Design controls, Risk management, Human factors engineering, FDA QSR, ISO13485, etc.

Major Duties and Responsibilities

  • Lead or be a strong technical contributor to a cross functional team in the selection, development, scale up and/or commercialization of drug delivery devices for the MedImmune pipeline
  • Be a senior scientific contributor to complex problem solving and technical development
  • Contribute to 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 and health authority responses
  • Develop and implement best practices / business processes

Requirements

Education:

  • Engineering or technical degree or equivalent.  BS required, MS or PhD preferred.

Experience:

  • Engineer: A minimum of 6 years of experience in technical roles within combination product development.
  • Sr Engineer: A minimum of 8 years of experience in technical roles within combination product development.

Other Skills and Qualifications:

  • Excellent leadership skills to lead a cross functional team and ensure success of the project.
  • Experience in working with external development and commercialization partners and suppliers is highly desirable.
  • A track record of working effectively within a matrix organization with a highly cross-functional and collaborative environment is required.
  • Excellent communication skills are required.
  • Familiarity with industry standards and practices applicable to device and/or combination product development is 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.

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Engineer/Senior Engineer - Device Development
MedImmune

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