Cell Therapy Specialist Job at AstraZeneca โ Freshers’ Life Science Graduates Apply Now
Are you ready to shape the future of cell therapy? AstraZeneca is hiring a Cell Therapy Associate Specialist to support its cutting-edge clinical manufacturing operations in Gaithersburg, MD. This role offers the unique opportunity to work in a state-of-the-art cell therapy facility, collaborate across cross-functional teams, and drive innovation in clinical trials. It is ideal for science and engineering graduates with a passion for biologics, cGMP, and hands-on manufacturing excellence.
AstraZeneca
Cell Therapy Associate Specialist
Gaithersburg, MD
About the job: Cell Therapy Manufacturing Associate Specialist
Introduction to the role
Are you ready to make a difference in the world of cell therapy? Join our Clinical Manufacturing Cell Therapy Unit at AstraZeneca and play a crucial role in producing next-generation products as we embark on our first wave of cell therapy clinical trials. This position is pivotal in supporting the start-up and cGMP operation of our new cell therapy manufacturing facility. Collaboration is at the heart of what we do, and you’ll work closely with Process Development, Clinical Operations, Materials Management, and Quality Teams to achieve our goals.
Accountabilities
- Author and execute manufacturing batch records, work instructions, and SOPs precisely.
- Maintain the bill of materials and assist with batch record reconciliation and documentation.
- Ensure all activities meet cGMP requirements.
- Assist with investigations into deviations, non-conformances, and out-of-specification results.
- Operate sophisticated automated cell processing, expansion, and filling equipment in cleanroom environments.
- Train personnel on aseptic processing, equipment operation, cGMPs, and technical theory.
- Review documentation for completeness and accuracy, submitting necessary edits.
- Participate in tech transfer activities and support process development.
- Provide technical instruction and allocate administrative tasks to the team.
- Ensure a safe work environment in line with AstraZeneca standards.
Essential Skills/Experience
- Bachelorโs degree in life sciences or engineering and 0-3 years cGMP manufacturing experience
- Basic knowledge in biologics manufacturing process, cell culture, and/or vector products.
- Technical proficiency in aseptic technique and working with manufacturing equipment in open and closed systems.
- Working knowledge of automated manufacturing equipment and/or process analytical technologies.
- Proficiency in Microsoft Word, Excel, and data analysis.
Desirable Skills/Experience
- Previous manufacturing or process development experience with 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 and identify opportunities to improve processes within the cGMP clinical manufacturing environment.
At AstraZeneca, we are driven by a commitment to deliver accelerated growth and improve lives through innovative solutions. Our Operations team thrives on challenges, constantly seeking new ways to turn molecules into medicines. With a focus on sustainability, we aim to be Zero Carbon by 2025 and carbon negative by 2030. Join us in a dynamic environment where you can contribute to meaningful change, supported by a community that values collaboration and continuous learning.
Keywords: Cell Therapy Associate Specialist, AstraZeneca, Gaithersburg, Manufacturing, Clinical Trials, Job Posting, cGMP, Biologics, Cell Culture, Vector Products, Aseptic Technique
