Cell Therapy Associate Specialist
Cell Therapy Manufacturing Associate Specialist
Introduction to 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 with precision.
Maintain 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
Bachelor’s 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/identify opportunities to improve processes within 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.
Ready to take the next step in your career? Apply now to be part of our journey!
The annual base pay (or hourly rate of compensation) for this position ranges from $62,105-$93,158. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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 authorization and employment eligibility verification requirements.