Associate Director, Cell Therapy Analytical Quality Team

Associate Director, Cell Therapy Analytical Quality Team

Gaithersburg, MD

Join our Oncology R&D group as an Associate Director, Cell Therapy Analytical Quality Team. The selected candidate will lead the Analytical Quality Testing group, responsible for analytical testing and support of clinical stage cell therapy products in accordance with GMP regulations. This includes management of lot release and stability programs, critical reagents, analytical tech transfer and sample chain of custody. The team engages with analytical development and several cross functional teams including clinical, regulatory, QA and manufacturing.

Accountabilities:

• Work collaboratively within the cell therapy technical operations (CTTO) group to manage the analytical GMP function.

• Ensure that the analytical GMP laboratory is efficient and compliant with regulatory, industry and AstraZeneca standards.

• As a key member of the CTTO analytical sciences team, you will provide strategic direction to ensure GMP compliance is met in all analytical activities.

• Lead and develop a team of scientists responsible for GMP lot release and stability testing, management of critical reagent and stability related activities, sample chain of custody, and analytical tech transfer.

• Drive lot release activities to maintain short vein to vein times.

• Represent the analytical GMP function in cross functional leadership team meetings related to manufacturing, analytical development, compliance, and lot release.

• Author, review, and approve SOPs, protocols, reports and other relevant documentation.

• Represent CTTO Analytical Sciences during regulatory and internal inspections.

• Work collaboratively with the Analytical Development team to ensure that analytical methods are appropriate and meet current regulatory requirements.

Essential Skills/Experience:

• BS/MS/PhD in Cell or Molecular Biology, Immunology, Biological Sciences, Biotechnology, Biochemistry, or related field. Experience: B.S. with 14+ years of experience, M.S. with 12+ years of experience, or Ph.D. with 6+ years of experience

• Prior experience managing a Quality Control or GMP testing laboratory and knowledge of cGMP and regulatory requirements for cell-based products, particularly CAR T-cells.

• Demonstrated ability to lead a team responsible for multiple project activities and ability to set the proper priorities to ex-implement them effectively.

• Expertise with methods and techniques for analysis of cell therapy products, such as: Flow Cytometry, ELISA, qPCR, dPCR, cell culture, cell count and viability measurement and cytotoxicity assays.

• Excellent written and verbal communication skills in a cross functional environment.

• Demonstrated ability to make decisions under pressure that balance patient safety, compliance and supply.

• Confirmed critical thinking skills.

• Strong interpersonal skills and demonstrated ability to effectively work across a large organization.

Desirable Skills/Experience:

• Prior experience performing/leading analytical testing of multiple products with short turn-around times.

• Experience with cell therapy regulatory inspections

• Experience with Labware Laboratory Information System (LIMS)

At AstraZeneca, we are on a mission to eliminate cancer as a cause of death. Our Oncology R&D team is at the forefront of this mission, pushing the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what's next. We foster a mindset of courage, where everyone is empowered to step up, innovate and work at pace. We lead through true collaboration, building collective wisdom by giving everyone a chance to input. It's science with an impact-making a difference for patients and people around the world.

About Our Gaithersburg Oncology Hub

Our Gaithersburg, Maryland facility creates 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 cutting-edge 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.

The Gaithersburg site offers a variety of amenities to help boost productivity 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 increasing collaboration between teams.

Ready to make a meaningful difference? Apply now and join us in our mission to eliminate cancer as a cause of death!

If you're curious to know more, please contact Bobbi Poole, our Talent Acquisition Partner.

Closing Date: July 4, 2024

Competitive remuneration and benefits apply

We offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We have a generous paid time off program and a comprehensive benefits package.

Where can I find out more?

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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 follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Date Posted

06-Jun-2024

Closing Date

03-Jul-2024Our 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.

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