Senior Production Associate, Clinical Manufacturing Cell Therapy Unit - 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:
- Author and execute manufacturing batch records, work instructions and/or SOPs, with a focus ‘right the first time’. Train others on aseptic processing, equipment operation, cGMPs, documentation, technical theory, or other tasks and ensure procedures are followed accurately.
- Routinely monitor, clean, prepare and operate sophisticated automated cell processing, cell expansion and filling equipment in Grades A & B cleanroom environment. Execute manufacturing and processing activities in open and closed single use systems, maintaining aseptic technique to ensure highest integrity, viability and sterility of product for release.
- Assign tasks to other manufacturing staff, lead activities on manufacturing floor, communicate staff and product status at shift change, and collaborate with management and support teams to troubleshoot processing and equipment issues.
- Support planning activities, including Bill of Materials generation, in alignment with dynamic manufacturing schedule to ensure clinical supply to patients.
- Ensure timely documentation of all activities, including process deviations, to meet cGMP requirements. Execute document reviews and revisions through GMP document management system. Review documentation (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents for revision as required. Assist with deviations/non-conformances/OOS investigations.
- Ensure a safe and environmentally sustainable work environment in accordance with AstraZeneca standards.
Education & Experience Requirements:
- Bachelor's degree in life sciences or engineering disciplines and 3+ years cGMP manufacturing experience.
- Significant knowledge in biologics manufacturing process, cell culture and/or vector products.
- Technical proficiency in aseptic technique working with manufacturing equipment in open and closed systems.
- Working knowledge of automated manufacturing equipment and/or process analytical technologies.
- Proven logic and decision making abilities, critical thinking and troubleshooting skills.
- Demonstrated leadership, organization and time management skills.
- Proficiency in Microsoft Word, Excel and data analysis.
- Previous research, manufacturing and/or process development experience with cell culture, cell therapy or vector products.
- Dynamic individual with the ability to communicate and engage others.
- Independent and self-starting. Ability to work with minimal supervision.
- Demonstrate flexibility and willingness to change ways of working/identify opportunities to improve processes within cGMP clinical manufacturing environment.
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.