Specialist II, MSAT and Manufacturing

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