Meet is partnered with a growing clinical-stage cell therapy biotech based in San Mateo County that is seeking a Manufacturing Specialist. They will be focused on executing manufacturing activities, leading improvement initiatives, and provide technical support for T-cell manufacturing process changes and process. This is a great opportunity for a hands-on manufacturing lead who will be supporting late-phase activities for oncology therapeutics.
Responsibilities:
Execute batch production, aseptic processing, and technology transfer, ensuring adherence to MBRs, SOPs, and cGMPs. Lead continuous improvement efforts to optimize operations and enhance product quality
Document activities per Good Documentation Practices (GDPs), author and review MBRs, protocols, deviation reports, and SOPs
Provide technical support for process changes, validation, and risk assessments, while participating in investigations, change controls, CAPAs, and root-cause analysis
Work closely with Process Development, Quality Control, Quality Assurance, Facilities, and Supply Chain to ensure timely product delivery
Complete necessary training to maintain adherence to quality standards and compliance
Requirements:
BS degree in a relevant discipline and 5+ years of industry experience in cell therapy manufacturing
Aspetic techniques and experience with cell processing equipment preferred
Ability to operate within a clean room environment
Adherence to cGMP requirements
Excellent organizational and prioritization skills
Contact:
For a confidential discussion, reach out to Amit at amit.uma@meetlifesciences.com.