Cell Therapy Technician

This position will support the start-up and cGMP operation of the new cell therapy manufacturing facility. Collaboration is key, and you will work together 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 needed.

• 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.

• Weekend work may be required.

Education & Experience Requirements:

Education: Bachelor’s or Master’s degree in life sciences, engineering, or a related field

Experience: Bachelor’s degree and 0-3 years of general cGMP manufacturing experience | Master’s degree and 0-2 years of general cGMP manufacturing experience

Required Skills:

• 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.