Associate Specialist (Cell Therapy Manufacturing)

Accountabilities

• GMP Documentation Excellence: 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.
• Aseptic Equipment Operations: Monitor, clean, prepare, and operate automated cell processing, cell expansion, and filling equipment in Grades A and B cleanrooms.
• Training and Knowledge Transfer: Train personnel on aseptic processing, equipment operation, cGMPs, documentation, and technical theory.
• Document Review and Continuous Improvement: Review batch records, SOPs, and logbooks for completeness, clarity, and accuracy; submit edits for revision as needed.
• Tech Transfer and Process Development: Participate in tech transfer activities; support development of platform processes; contribute to study and experiment designs; modify or improve processes and systems when appropriate.
• Floor Leadership and Problem Solving: 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.
• Safety and Compliance Stewardship: Ensure a safe work environment in accordance with AstraZeneca standards.

Essential Skills/Experience

• 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

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

Pay

The annual base pay for this position ranges from $65,082 to $97,622.

Benefits

• Eligibility for various incentives—short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
• Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.