Cell Therapy Manufacturing Associate Specialist/Specialist
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 place 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.
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. Collaboration 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'. Author and maintain bill of materials. Assist with batch record reconciliation and timely documentation. Documentation of all activities to meet cGMP requirements. Assist with deviations/non-conformances/OOS investigations.
Routinely monitor, clean, prepare and operate sophisticated automated cell processing, cell expansion and filling equipment in Grades A & B cleanroom environment.
Train other personnel on aseptic processing, equipment operation, cGMPs, documentation, technical theory, or other tasks.
Review documentation (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents for revision as required.
Participate in tech transfer activities. Support process development of platform processes, contributing to the plans and designs of studies/experiments. May modify or improve processes and systems, depending on purpose of experiments
Provides technical instruction to the team and allocates administrative work where possible - assigning tasks to other manufacturing staff, leading activities on manufacturing floor, communicating to staff about product status at shift change, troubleshooting processing and equipment issues.
Ensures a safe work environment in accordance with AstraZeneca standards.
Education & Experience Requirements:
Associate Specialist: Bachelor's degree and 0-3 years of cGMP manufacturing experience
Specialist: Bachelor's degree and 3+ years of cGMP manufacturing experience or a Master's degree and 2+ years of cGMP manufacturing experience or 1 year of Cell Therapy experience
Required Skills:
Associate Specialist Level:
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.
Specialist Level:
All required skills for Associate Specialist level plus the following:
Significant knowledge in biologics manufacturing process, cell culture and/or vector products.
Demonstrated leadership, organization and time management skills.
Proven logic and decision making abilities, critical thinking and troubleshooting skills.
Desired Skills:
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.
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 groundbreaking 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. Apply today!
Date Posted
17-Sep-2024Closing Date
03-Oct-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.