Director, Device Development - Parenterals Drug Delivery Devices

Job Title: Director, Device Development - Parenterals Drug Delivery Devices
Location: Boston, MA

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. 

 Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. 

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As AstraZeneca continues to put patients at the forefront of our mission, we are excited for our move to Kendall Square/Cambridge in 2026. Find out more information here: Kendall Square Press Release

Introduction to Role:

A Director in Device Development leads parenteral combination product development activities from early stage innovation through clinical development and launch. Typical development work includes leading technology selection, technology characterization, leading combination product development 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.

The position includes direct leadership of device teams as well as mentorship of junior engineers.  The incumbent will work cross-functionally with both internal staff and leaders across Development, Quality, Regulatory, Commercial, Operations, and with CMC Teams, and Global Product Teams (GPTs).  

Accountabilities:

• Lead large cross functional teams/programs. Provides support to junior staff
• Subject matter expert in engineering principles for the design and development of robust parenteral devices 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 parenteral devices (e.g. prefilled syringes, autoinjectors, pens)
• Strategic program management with oversight to 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

Essential Skills/Experience:

• Bachelors Degree and a minimum of 15 years of related experience. Masters Degree and a minimum of 12 years of related experience or PhD and a minimum of 10 years of related experience. The candidate should have at least 8 years of experience in parenteral combination product development

• Experience in the following areas: parenterals device technologies, 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 Skills/Experience:

• Substantial post graduate experience in parenteral device/process development

Where can I find out more?

• Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
• Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
• Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

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Date Posted

07-Apr-2025

Closing Date

25-Apr-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.