Manufacturing Specialist

Position Summary

The Manufacturing Specialist – Cell Therapy is responsible for supporting GMP manufacturing operations for cell therapy products. This role involves execution of batch records, aseptic processing, and ensuring compliance with regulatory and quality standards. The ideal candidate will have hands-on experience in cell therapy manufacturing and batch record documentation.

Key Responsibilities

• Perform manufacturing activities for cell therapy products in a GMP-regulated environment
• Execute and document production steps according to approved Batch Production Records (BPRs)
• Perform aseptic processing, cell culture, cell expansion, and related techniques
• Ensure accurate, real-time documentation of batch records and manufacturing logs
• Follow Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP)
• Assist in investigations, deviations, and CAPA activities
• Maintain cleanroom standards and adhere to gowning procedures
• Support equipment preparation, cleaning, and maintenance activities

Minimum Qualifications

• High School Diploma (HSD) + 2 years of manufacturing experience in biotech, pharmaceutical, or cell therapy environment OR
• Associate’s or Bachelor’s degree in Life Sciences or related field + 1 year of relevant manufacturing experience
• Hands-on experience in cell therapy OR pharmaceutical manufacturing
• Experience executing and reviewing Batch Production Records (BPRs)
• Familiarity with GMP documentation practices
• Experience working in cleanroom/controlled environments
• Knowledge of aseptic techniques
• Experience with cell culture and cellular processing