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Senior Engineer, Device Development, DFDD

Lieu South San Francisco, Californie, États-Unis Gaithersburg, Maryland, États-Unis Job ID R-129532 Date de publication 03/30/2022

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:

The parenteral device development group at AZ is responsible for design and development of combination products and medical devices to bring our life changing medicines to patients. In this role, you will lead or make strong technical contributions within cross functional combination product development teams and/or to complex technical development and problem-solving projects based on a robust understanding of engineering fundamentals, the product requirements, and business needs. You will be responsible for successful completion of design, development and commercialization deliverables and ensuring that device design, primary container design, component selection, manufacturability and testing specifications and methods meet product needs.

You must effectively collaborate with staff and leaders in Device Development, Quality, Regulatory Affairs, Drug Development, Process Engineering and across other areas of Biologics Product Development and AstraZeneca. 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.

Main Duties & Responsibilities:

  • Lead or be a strong technical contributor to a cross functional team in the selection, development, scale up and/or commercialization of primary containers and/or drug delivery devices for the AstraZeneca pipeline
  • Leads or participates in technically demanding projects within specific area or field of Subject Matter expert. Applies engineering principles for the design and development of robust devices/methods/processes that meet patient, molecule and business needs.
  • Strong technical capability in solving complex problems using tools such as: mechanistic and statistical modelling and simulation tools, design and prototyping tools, statistical analysis, benchtop experiments and analysis, usability engineering tools, design for manufacturability/assembly techniques and design for six sigma
  • Contribute to departmental combination product and primary container development capability by applying and maintaining a high level of knowledge and expertise
  • Strong knowledge of regulations and standards such as design controls, risk management, human factors and industry standards specific to an individual’s subject area (e.g. risk management, Design Controls, FDA QSR, ISO13485, ISO standards etc.)
  • Establish a close working relationship with and provide effective oversight of suppliers and manage technical aspects of external collaborations
  • Drive a Quality approach and ensure that work is performed in accordance with appropriate quality requirements and compliance to standards
  • Contribute to regulatory filings and health authority responses
  • Develop and implement best practices / business processes

Education & Experience Requirements:

  • Education: BS and 10 plus or MS and 8 plus or PhD and 0 years of experience.
  • Experience: 8-12 years of experience in technical roles within combination product and/or primary container development, depending on the highest level of education completed and the level of applicable expertise.

Required Skills:

  • Excellent leadership skills
  • Ability 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 primary container, device and/or combination product development is required.

Desired Skills:

Substantial post graduate experience in combination product & device/process development

Why AstraZeneca?

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

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AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants. COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation.

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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