Team Leader - Cell Therapy Manufacturing - BPD
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:
Join the Clinical Manufacturing Cell Therapy Unit and be a part of producing AstraZeneca's next-generation products as we launch our first wave of cell therapy clinical trials. This position will support the start-up and cGMP operation of the new cell therapy manufacturing facility. Teamwork is key, and you will collaborate frequently with Process Development, Clinical Operations, Materials Management, and Quality Teams.
Main Duties & Responsibilities:
- Manages all tasks and resources required for manufacturing cell therapy products including scheduling & staffing production activities, batch record & bill of materials creation/revision, SOP(s) creation/revision to meet dynamic manufacturing schedule and ensure timely clinical supply delivery to patients.
- Reviews and approves batch documentation, SOPs, BOMs, Tech Transfer documents, etc.
- Leads complex investigations with demonstrated scientific and technical writing abilities, ensuring product quality and patient safety.
- Routinely engages with production staff on the manufacturing floor as well as all supporting functions and effectively communicates product status to appropriate stakeholders in order to keep them informed and involved (QA/QC, Analytical Development, Clinical Operations, Process Development, Regulatory Affairs, etc).
- Provides technical direction and leadership to direct reporting staff and others in the team via matrix-style organization, as well as cross-functionally. Responsible for performance management of direct reports including coaching, goal setting and career development.
- Independently identifies and resolves complex problems through good decision quality utilizing functional and technical skills and resources.
Education & Experience Requirements:
- Bachelor's degree in life sciences or engineering discipline and 8+ years OR Master's degree and 6+ years of cGMP manufacturing experience.
- Strong team leadership and interpersonal skills. Previous experience in cell culture manufacturing and/or process development, or vector products.
- Has in-depth knowledge of multiple disciplines and technical areas with significant focus on biologics process and proven ability to apply expertise, scientific principles, theories, and concepts in practice.
- Develops solutions to complex problems requiring ingenuity and creativity.
- Displays knowledge about how the organization works and solves problems through formal channels and informal networks.
- Dynamic individual with strong communication, collaboration, and organizational skillsets.
- Comfortable with ambiguity and ability to work independently without appreciable direction.
- Previous supervisory experience.
- Previous experience creating, maintaining, and reporting success metrics and team KPI’s.
- In depth knowledge of OE & Lean Manufacturing principles and quality risk management.
- In depth knowledge of biologics drug development process, clinical timelines and CMC.
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 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 authorisation and employment eligibility verification requirements.