Applications Development Director jobs in Reston, VA

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 Gaithersburg, MD:

Our Gaithersburg, Maryland facility crafts 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 ground-breaking technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and encouraged at work. We are dedicated to crafting a culture of inclusion and collaboration.

The Gaithersburg site offers a variety of amenities to help boost efficiency 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 growing collaboration between teams.

Summary of the group:

The Oncology CMC cell therapy group sits within the Cell Therapy Technical Operations (CTTO) group in the Oncology Research and Development department and operates cross-functionally and globally to develop innovative cell therapies. The current T cell therapy pipeline includes autologous CAR-T, CAR-TCR, CAR-Treg and off-the-shelf allogeneic cell therapies which use novel manufacturing approaches and ground-breaking technologies for clinical testing.

Main Duties & Responsibilities:

AstraZeneca's CTTO group in Gaithersburg, MD is seeking an exceptional, creative and motivated candidate to join the Oncology Cell Therapy CMC group in a key leadership role.  Reporting to the Head of Cell Therapy CMC in Gaithersburg, the Director/Senior Director will be responsible for developing and advancing Universal Effector Cell (UEC) allogeneic manufacturing technology and pipeline candidates using emerging and innovative approaches to establish a GMP manufacturing process.  The candidate will lead a group that works cross-functionally with research and other teams to promote, develop and optimize a novel allogeneic CAR-T platform.

Summary of activities to lead include, but are not limited to:

• Lead a group of process scientists and engineers to develop and optimize novel allogeneic CAR-T therapy processes for transfer into clinical manufacturing

• Partner with research teams to advance novel cell therapy drug designs.  Projects include non-viral gene delivery and gene edited Universal Effector Cells

• Collaborate with tech transfer and manufacturing groups to implement a process to support clinical development of multiple drug candidates

• Work with analytical, quality and safety groups to define and drive a regulatory strategy for release testing and characterization

Additional Responsibilities:

• Contribute to regulatory filings and scientific reports

• Represent the group at internal and external scientific meetings

• Work in a cross-functional matrixed environment and draw on assistance of other teams to meet goals

• Resource modelling, timelines and resource allocation to deliver on group goals

Education & Experience Requirements:

Director:  BS Degree and 12 years of exp, MS and 10 years or PhD and 8 years of experience

Sr. Director:  BS and 15, MS and 12 years and PhD and 10 years of experience

Required Skills:

• Biotechnology or pharmaceutical proven experience working in GMP environment and FDA-regulated industry

• Demonstrated cell therapy, CAR-T process development experience leading to successful regulatory filings, tech transfer, and clinical supply

• Extensive experience with T cell culture and optimization, gene-editing, molecular biology

• Knowledge of proper analytical method application for the characterization of drug process intermediates

• Process development, scale-up, risk-based development using Design of Experiments (DOE) principles, statistics and data analysis programs such as JMP

• Experience with scale down model development and validation contributing to optimization of large scale processes

• Demonstrated ability to recruit and form highly functional and stable teams, utilize diverse experiences and develop staff

• Highly organized, able to work in a fast-moving environment and prioritize work to achieve goals

• Strong oral and written communication skills for effective communication

Desired Skills:

• Strong knowledge of GMP compliance, regulations, and manufacturing operations

• Experience with Risk Management tools (eg. FMEA)

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 outstanding and bold world.

Why AstraZeneca?

We are proud to work for AstraZeneca for many reasons. Most recently, we are proud of our development of a vaccine and antibodies to treat or prevent COVID19. During the pandemic, we have pledged to forgo any profit from these products. We are also working to make these products available globally! We are working incredibly hard on these and other projects and need you to join us, so we can be successful.

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, groundbreaking innovative 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  https://careers.astrazeneca.com/bpd

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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 authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.