Manufacturing Lead - Downstream

Job Responsibilities:

• Lead the execution of downstream manufacturing activities such as clarification, chromatography, TFF, and filling, working collaboratively within a team.
• Serve as a liaison with downstream process development subject matter experts (SMEs) to stay updated on the latest processes and ensure seamless translation of these to the GMP manufacturing environment.
• Manage material supplies to ensure downstream manufacturing areas are stocked and ready for operations.
• Assist with the maintenance of laboratory equipment and support overall lab operations.
• Lead the creation, review, and revision of SOPs, batch records, and forms in collaboration with management, Process Development, and Quality Assurance teams.
• Provide clear direction to operators on downstream manufacturing processes and assist with training and coaching as needed.
• Accurately follow detailed instructions and ensure timely, precise documentation of all manufacturing activities.
• Maintain current training status and ensure compliance with all relevant policies and SOPs.
• Lead troubleshooting efforts for downstream manufacturing issues, working with Manufacturing Management when necessary.
• Train new team members and colleagues on downstream manufacturing processes.
• Conduct safety inspections and maintain a safe work environment.
• Perform sanitization of manufacturing areas and properly collect/dispose of waste.
• Collect process data for trending and metrics.
• Support GMP product optimization and improvements.
• Assist in specification development, review, and implementation through CAPAs and change controls.

Qualifications:

• Bachelor’s degree in Biology, Biochemistry, Molecular Biology, or a related field.
• 2 years of experience in a GMP environment.
• 2 years of experience operating in a GMP laboratory using aseptic techniques and risk mitigation strategies.
• Experience with chromatography and TFF platforms.
• Experience in cell and gene therapy manufacturing or viral vectors is desired.