Director, Device Development at AstraZeneca in Waltham, Massachusetts

Job Description:

Director (Device Development)


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 place 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 Boston, MA:
Our AstraZeneca facilities create life-changing medicines for people around the world. Our Boston campus play host to some of the most innovative 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.


Summary of the group:
The Device Project Management Group drives AstraZeneca device project delivery, supporting clinical studies and commercial launch. Device Project managers plan, coordinate, and deliver Device activities in line with project requirements and timelines; plan and monitor resources and expenses for product development; and perform strategic planning for platform and novel processes. The group interfaces globally with the CMC team, Drug Product team, Operations, Quality, Regulatory, and all development functions.


Main Duties & Responsibilities:
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, product requirements, and business needs. Typical development work includes leading technology selection, technology characterization, leading combination products for clinical and commercial applications; implementing robust engineering tools like simulation based mechanistic and statistical models, design controls and risk management compliance; strategic engagement with external vendors and CMOs, and appropriate sequencing and interpretation of development work to ensure program goals are met.


• Lead large cross functional teams/programs. 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.
• Expert knowledge of regulations and standards such as design controls, risk management, human factors and industry standards specific to an individual's discipline
• Strategic program management and overseeing cross functional program decisions and risks. Anticipates potential design/process problems, analyzes problems following best practices, provides practical solutions and manages the consequences of any failures.
• Demonstrated ability to lead 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
• Expertise 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
• Represents the function in senior review forums
• Ensures compliance of own work and the work of others within established Safety, Health, and Environment standards


Education, Qualifications, Skills and Essential Experience:
Bachelors Degree and a minimum of 12 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.
- Experience in the following areas: new device 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


Desirable:
Substantial post graduate experience in parenteral device/process development


When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and daring world.


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 recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering groundbreaking 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.


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 authorization and employment eligibility verification requirements.