Manufacturing Specialist

Position SummaryThe 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 ResponsibilitiesPerform manufacturing activities for cell therapy products in a GMP-regulated environmentExecute and document production steps according to approved Batch Production Records (BPRs)Perform aseptic processing, cell culture, cell expansion, and related techniquesEnsure accurate, real-time documentation of batch records and manufacturing logsFollow Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP)Assist in investigations, deviations, and CAPA activitiesMaintain cleanroom standards and adhere to gowning proceduresSupport equipment preparation, cleaning, and maintenance activitiesMinimum QualificationsHigh School Diploma (HSD) + 2 years of manufacturing experience in biotech, pharmaceutical, or cell therapy environment ORAssociate's or Bachelor's degree in Life Sciences or related field + 1 year of relevant manufacturing experienceHands-on experience in cell therapy OR pharmaceutical manufacturingExperience executing and reviewing Batch Production Records (BPRs)Familiarity with GMP documentation practicesExperience working in cleanroom/controlled environmentsKnowledge of aseptic techniquesExperience with cell culture and cellular processing

Created: 2026-05-16