Technical Lead Clean Room

The Technical Lead for Clean Room Operations will play a critical role in ensuring seamless daily production tasks within Manufacturing Operations. This role involves building strong partnerships across various departments, including Quality Control, Quality Assurance, Facilities & Engineering, Manufacturing Science & Technology (MS&T), Training, Planning, and the Warehouse. The Technical Lead will serve as the first point of contact for technicians and experts on the production floor, addressing production issues and working as part of a cross-functional team.Key Responsibilities:Quality Assurance Leadership:Coordinate, manage, and control all quality aspects related to production activities and batch production in cGMP areas.Timely review of production documentation (procedures, work instructions, logbooks, transfer forms).Act as a backup for the Operations Supervisor in reviewing executed batch records (both paper and MES).Conduct routine and spot-check inspections on production documentation.Manage production-related QMS documentation (deviations, CAPA, SOPs, cleaning validation, protocols, and reports) in collaboration with MS&T and Quality.Review cGMP documents generated by Production before QA review.Support communication of KPIs related to quality aspects in Production.Act as the production SME for internal and external audits in collaboration with QA, escalating production-related matters to ensure timely decisions and follow-up.Production Process Expertise:Provide guidance and perform production tasks in alignment with safety policies, quality systems, and cGMP requirements.Support Tech Transfer plans for new production introductions or process optimisations, including risk assessment, execution, and readiness for clinical and commercial phases.Participate in developing manufacturing processes and continuous improvement initiatives within cell therapy Technical Operations.Assist in the qualification/validation of new materials, consumables, and equipment.Support drug product investigations, including batch failures.Participate in training sessions for various manufacturing processes.Communicate KPIs related to production output.Operational Management:Attend and lead (in absence of the Ops Supervisor) daily start-of-shift and wrap-up production meetings.Assign daily production tasks and ensure their successful completion.Organize training sessions in collaboration with the Training team and Operations Supervisor.Collaborate with the Operations Supervisor and Manager to oversee the development of production personnel and provide performance feedback.Support quality and EHS risk assessments for production activities, zones, equipment, materials, and data.Assist in the design, specification, construction, qualification, validation, and regulatory approval of production capabilities.Identify issues and drive continuous improvement initiatives for production operations.Manage inventory and ensure material availability in production zones.Monitor production areas in collaboration with Maintenance/Engineering, QC, and Facility teams.Ensure safe and compliant manufacturing operations per EHS and cGMP procedures.Work collaboratively and flexibly within the team.

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