Manager, Technical Affairs - USA

Irvine, CA | Reports to the Senior Director, Operations

The Role

Oversee and manage daily production, including sample processing, analysis, manufacturing, quality control and cryopreservation at our facility in Irvine, CA.

Lab Operations

• Manage lab technicians as direct reports.

• Manage staff scheduling.

• Assist in annual performance reviews for all lab technicians.

• Ensure proper upkeep and working function of equipment and facility for the processing, analysis, cryopreservation, production, quality control, packaging and distribution of client samples.

• Assist senior lab leadership in writing and reviewing SOPs, improving the overall quality of systems and processes.

• Coordinate training and implementation of new and updated SOPs, and ensure continued education of operations teams.

• Coordinate with the commercial and operations client solutions teams, and keep looking for additional efficiencies while considering product quality and customer satisfaction.

• Work closely with the Operations Manager on procurement of supplies and equipment.

• Ensure adherence to health and safety guidelines.

Quality Control

• Work closely with the Quality Manager.

• Analyze and approve quality control results in a timely manner.

• Monitor activities across all lab processes to ensure adherence to quality standards and regulatory compliance, if applicable.

• Assist in conducting regular audits of client lab records, facilities and the QMS.

• Assist the Quality Manager and senior lab leadership in addressing deviations, non-conformances and corrective actions, and execute and implement preventive action plans as necessary.

• Communicate any changes in processes, audit findings and corrective actions to upper management in a timely manner.

• Assist senior lab leadership in writing and/or conducting validations and verifications, as necessary.

• Prepare and/or present lab data in quarterly quality meetings.

• Ensure lab-wide adherence to the quality management system, improving the overall quality of systems and processes.

Product Development & Improvement

• Support the PDI (R&D) team in driving forward innovation in hair follicle and stem cell research.

• Join weekly PDI team meetings and actively participate in the science team's strategic planning, experiment analysis and reporting.