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Associate Director, Device Engineer- Durham, NC

Location Durham, North Carolina, United States Job ID R-121803 Date posted 20/10/2021

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 to Associate Director Device Engineer 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:

  • Effectively lead, guide, manage and mentor team of  internal and external cross-functional technical resources to deliver Medical Device and Combination Product including state of the art inhaler devices
  • Lead platform and combination product development of Inhaler programs.
  • Define, monitor and manage project budgets, spending and resource plans.
  • Accountable for product development-related device regulatory sections filed across global markets
  • Anticipate and manage project risks and issues, and provide specific mitigation and corrective action strategies
  • Develop presentations and communicate project status against key project milestones and budget for a broad set of stakeholders.
  • Line manager for a team of Device Development Engineers
  • Organize, prepare and host design review meetings in order to ensure controlled and documented completion of typical device development stages.
  • Supports lean and process improvement initiatives

Essentials:

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

Required:

  • Proven record of successful development leadership, project planning, and problem-solving in the area of inhalation products and/or combination products, including working with sense of urgency to meeting project goals.
  • Proven experience managing multiple projects and/or programs concurrently
  • Extensive experience with Design Controls, ideally in combination products
  • Skilled leader of cross-functional teams with senior specialists and highly skilled employees
  • Knowledge across the entire development process from concept process phase through development, regulatory submission and approval, transfer, and launch.
  • Strong Project Management skills
  • Strong analytical problem-solving skills and attention to detail

Desired:

  • Subject matter expertise in inhalation (MDI, DPI) drug-devices
  • Familiar with medical device and combination product standards including: US Good Manufacturing Practices - 21CFR820, Quality Management – ISO 13485,  Risk Management - ISO 14971, Medical Electrical Equipment – EN 60601, Aerosol drug delivery device design verification - ISO 20072
  • Experience authoring IND/IMPD/NDA/MAA regulatory filings
  • Familiarity with requirements management software to document requirements and  traceability
  • Experience in leading lean and continuous improvement activities.
  • Energized by a lean and fast-paced work environment
  • Experience working with hardware/software-based product development, ideally with connected devise
  • Demonstrated proficiency managing rapidly changing priorities and aggressive timelines
  • Demonstrated ability to monitor, management and grow diverse external partnerships

Why AstraZeneca?

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.

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