Currently responsible for spearheading change control processes and representing the quality department in project meetings. Provide expert guidance in writing, revising, and reviewing SOPs, contributing to quality-related matters during FDA inspections. Proficient in tracking and analyzing metrics for continuous improvement, adept at reviewing deviations, and collaborating on root cause analysis. Conduct staff training on GMP, investigations, and contribute to multiple programs in various development phases. Lead environmental monitoring, support data analysis, and actively participate in audit activities.

Responsible for performing GMP manufacturing of viral vectors in either the Upstream and/or Downstream process areas, preparing the plasmids used in the viral vector manufacture, and contributing and providing input into activities such as training, procedure writing, troubleshooting, equipment and room cleaning, batch record execution and finalization, deviation investigation and closure, change controls and CAPA effectiveness. Additionally, ensuring execution of processes on-time while continuously improving in quality and efficiency performed in compliance to cGxPs, SOPs and applicable guidelines.

Responsible for managing logistics for material operations in and out of the StrideBio sites, reporting into our Manager, Materials Management, showcasing initiative and mindset for continuous improvement with interest in working in an entrepreneurial environment, and supporting the Laboratory and Materials Manager in daily activities and projects. Additionally, supervise inventory receipt, storage, replenishment, and disbursement; maintaining inventory accuracy; manage inventory movements between multiple company sites; participate in the evaluation of root cause and corrective actions for any material management non-conformances. Help lead process improvements.

Embodies excellent customer service, sparks innovation in every task, seeks information resourcefully, and drives to create an energetic and safe atmosphere where BioLabs members thrive. Responsible for overall laboratory operations while assisting in all duties associated with running a co-working lab space and possess the ability to work well both independently and collaboratively in a team environment.