Process Engineering Manager jobs in Cambridge, MA

Associate 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.

Summary of the group:

The Device Development Group sits in the BioPharmaceutical R&D organization. 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 systems and has several new Technology Development projects.

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 driving technology selection, technology characterization, developing 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.

• Ability to lead large cross functional teams/programs. High functioning expert 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 knowledge of 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, analyzes problems following standard methodologies, provides practical solutions and handles 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

• 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 & Experience Requirements:

Bachelor’s Degree and 12 years of related experience with at least 8 years of experience in medical device or combination product development.

or

Master’s Degree and 10 years of related experience with at least 8 years of experience in medical device or combination product development.

or

PhD and 5 years of related experience with at least 5 years of experience in medical device or combination product development.

Required Skills & Experience:

• Experience in some of 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

• Strong 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 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.