Associate Specialist (Cell Therapy Manufacturing)
About The Position
Are you ready to bring precision and initiative to the start-up of a new cell therapy manufacturing facility—seeing your work translate into clinical trials that could change patients’ lives? Join a team producing next-generation cell therapy products at a pivotal moment as our first clinical batches move from process development into cGMP operation. In this visible, hands-on role, you will collaborate daily with Process Development, Clinical Operations, Materials Management, and Quality to turn robust science into reliable manufacturing outcomes. You will help build the documentation, run sophisticated automated equipment in Grades A and B cleanrooms, and lead by example on the floor to keep every batch on track. Can you picture yourself owning a “right first time” mindset and guiding a shift handover that keeps a critical lot moving?
Requirements
- Bachelor’s degree in life sciences, engineering, or a related field with 0-3 years of general cGMP manufacturing experience or a Master’s degree in life sciences, engineering, or a related field with 0-2 years of general 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.
Nice To Haves
- 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.
Responsibilities
- Author and execute manufacturing batch records, work instructions, and SOPs with a “right first time” mindset; maintain bills of materials; reconcile batches promptly; document all activities to meet cGMP requirements; assist with deviations, non-conformances, and OOS investigations.
- Monitor, clean, prepare, and operate automated cell processing, cell expansion, and filling equipment in Grades A and B cleanrooms.
- Train personnel on aseptic processing, equipment operation, cGMPs, documentation, and technical theory.
- Review batch records, SOPs, and logbooks for completeness, clarity, and accuracy; submit edits for revision as needed.
- Participate in tech transfer activities; support development of platform processes; contribute to study and experiment designs; modify or improve processes and systems when appropriate.
- Provide technical instruction; allocate administrative tasks; assign work to manufacturing staff; lead activities on the manufacturing floor; communicate product status at shift change; troubleshoot processing and equipment issues.
- Ensure a safe work environment in accordance with AstraZeneca standards.
- Weekend work may be required.
Benefits
- Qualified retirement programs
- Paid time off (i.e., vacation, holiday, and leaves)
- Health coverage
- Dental coverage
- Vision coverage
- Eligibility for various incentives
- Opportunity to receive short-term incentive bonuses
- Equity-based awards for salaried roles
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
