Director or AD - Biopharmaceutical Device Development
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.
Summary of the Group:
The Device Development Group sits in the Biopharmaceutical R&D organization and has offices in Gaithersburg, MD and South San Francisco, CA. The group is responsible for design, development, healthcare authority approval and ultimately launch of drug/device combination products. The product portfolio is mainly focused on subcutaneous drug delivery system, and also have several new Technology Development projects in other related areas.
In this role, you will lead the design, development, and implementation of biopharmaceutical devices and will execute based on a deep understanding of engineering fundamentals, the product requirements, and business needs. Typical development work includes technology selection, technology characterization, engineering calculations and/or simulations based on mechanistic and statistical models; design controls and risk management compliance, collaboration with external vendors and CMOs, appropriate sequencing and interpretation of development work to ensure program goals are met.
Leads large cross functional teams/programs. High functioning collaborative team member for programs with substantial scope. Provides support to junior staff
Subject matter expert in engineering principles for the design and development of robust devices/methods/processes that meet patient, molecule and business needs.
Subject matter expert in solving complex problems using tools such as: engineering 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
Strong working knowledge with regulations and standards such as design controls, risk management, human factors and industry standards specific to an individual’s discipline
Highly skilled in proactive program management and strategically evaluating cross functional program decisions and risks. Anticipates potential design/process problems, analyses problems following best practices, provides practical solutions and manages the consequences of any failures Demonstrated ability to manage and integrate technologies/processes in the development, scale up and commercialization of complex multicomponent products that will be manufactured across a global network of suppliers
Establishes frequent inter and intradepartmental collaborations that expand business opportunities for the company, improves the efficiency and effectiveness with which we operate and provide development opportunities within the function
Recognized as a subject matter leader within and external to AstraZeneca and represents the function in senior review forums. Leads external work with CMOs and development partners.
Ensures compliance of own work and the work of others within established Safety, Health, and Environment standards
Education, Qualifications, Skills and Experience Essential:
-Bachelors Degree and a minimum of 13 years of related experience with at least 8 years of experience in medical device or combination product development.
-Masters Degree and a minimum of 10 years of related experience with at least 8 years of experience in medical device or combination product development.
-PhD and a minimum of 6 years of related experience with at least 5 years of experience in medical device or combination product development.
For Associate Director:
-Bachelors Degree and a minimum of 11 years of related experience with at least 6 years of experience in medical device or combination product development.
-Masters Degree and a minimum of 7 years of related experience with at least 5 years of experience in medical device or combination product development.
-PhD and a minimum of 4 years of related experience with at least 3 years of experience in medical device or combination product development.
- Experience in some of the following areas: new technology development, combination product development, human factors, methods development, device/process characterization, design controls, risk management, process development
- Understanding of cross functional product development
- Communication skills (both written and oral) to summarize development work, critical conclusions and it’s relevance to the larger program
- Knowledge of procedures and compliance with Good Manufacturing Practice & Safety, Health and Environment requirements
-- Knowledge and understanding of device/process development
Substantial post graduate experience in device/process development
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.
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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.