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Senior/Principal Scientist - Cell Therapy - BPD

Location Gaithersburg, Maryland, United States Job ID R-106425 Date posted 23/04/2021

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 one 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 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. 

Summary of the group:

The Cell Therapy Unit sits within the Bio Pharmaceutical Development (BPD) group, and works closely with Oncology.  The functional groups include Platform Technologies, Process and Analytical development, and manufacturing.  Projects in the wider group include vaccines, therapeutics, biologics, and the new cell therapy effort.  Current pipeline include autologous CAR-T and off-the-shelf allogeneic cell therapy, as well as more cutting edge technologies.

Main Duties & Responsibilities:

AZ Cell Therapy group is seeking exceptional and motivated individuals to join the novel Cell Therapy group in a key leadership role.  Reporting to the Head of CMC, the Senior Scientist/Principal Scientist, MS&T will be responsible for supporting pipeline candidates through process characterization, and support technology transfer and cGMP manufacturing.  Candidate will lead a group to support the pipeline CAR-T products, as well as a range of innovative cell and gene therapy projects.

Summary of activities include, but are not limited to:

  • Support the tech transfer of CAR-T processes to CMO and internally for early phase cGMP clinical manufacturing. 
  • Provide support to manufacturing operations, including data capture, batch record and testing form review, deviation investigation and CAPAs, risk assessments, and FMEA. 
  • Oversee and lead the training of the cGMP manufacturing staff.
  • Contribute to the design and execution of process development experimental plans in collaboration with the development team.
  • Lead process characterization activities design space of candidate processes using QBD and DOE approaches
  • Manage production of non-clinical materials for the pipeline products
  • Direct, develop, and mentor staff. Provide an environment that enables collaboration and effective teamwork Identify and facilitate change for increased organizational effectiveness and competitive advantage.

In addition:

  • Direct MSAT group in the planning and execution of projects and activities aligned with the function profile for MSAT
  • Accurately capture data in a timely manner, ensuring data integrity and protocol compliance. 
  • Maintain all individual training requirements in a compliant state. 
  • Contribute to regulatory filings as needed. 
  • Execute improvement projects, drive continuous improvement activities to improve departmental efficiency, resource utilization and quality compliance

Education & Experience Requirements:

Degree in a relevant field within the biological sciences 

Principal Scientist: BS and 17+ years of relevant experience, or MS and 15+ years of relevant experience or PhD and 11+ years of relevant experience.

Senior Scientist: BS and 15+ years of relevant experience, or MS and 13+ years of relevant experience or PhD and 7+ years of relevant experience.

Required Skills:

  • Biotechnology or pharmaceutical industry experience working in GMP environment and FDA-regulated industry.
  • Extensive experience with cell therapy development, tech transfer, or manufacturing
  • Experience with use and troubleshooting of cell processing using common platforms
  • Experience leading teams of scientists

Desired Skills:

  • GMP training
  • Cell therapy, CAR-T or vector development
  • Process development, QbD, and risk-based development using statistics and programs such as jmp
  • Proven track record of MSAT and Tech Transfer experience supporting contract and strategic alliance Manufacturing
  • Strong knowledge of GMP compliance, regulations, and Manufacturing Operations
  • Expertise in Process Validation lifecycle and especially PPQ, Comparability and CPV
  • Cell culture and aseptic processing experience
  • Experience with Risk Management tools (eg. FMEA)

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 recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge 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

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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 authorisation and employment eligibility verification requirements.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.