• Led all GMP cell banking and cell culture expansion activities in clinical manufacturing for all new antibody projects. Authored controlled manufacturing documentation as the SME. Worked closely with all stakeholders as the upstream group advocate to ensure project timelines and goals are met. Performed post manufacturing review with quality group and authors internal manufacturing reports. • Coordinated upstream GMP activities for all antibody clinical drug substance campaigns.• Addressed deviation reports and corrective/preventative actions with quality and manufacturing team as necessary. • Conducted complex process development experiments independently. Experiments include but are not limited to clone selection to pre-clinical process development. • Based on scientific understanding of the process, applied GMP requirements to process development and process transfer activities in support of phase I and II clinical manufacturing.• Analyzed data to draw scientific conclusions and present key scientific findings in departmental and division presentation forums.• Instructed and trained contract, junior, and new employees in the areas of cell culture and cell line development as well as clinical manufacturing. Mentored contract and junior employees through exposure to career tools and experiences. Directly managed and developed one contract employee. Encouraged continuous education at all levels.

Scientific Role: Performs development on clinical pipeline projects including antibodies. Well-versed in mammalian cell culture fed-batch and perfusion processes in 2-1000L bioreactors including scale up in shake flasks.Management Role: Coordinates upstream projects into clinical manufacturing. Acts as the main operator for cell culture in a clinical setting. Coordination of technology transfer activities to support early and late-stage manufacturing batches. Authoring and reviewing Batch Records/SOPs and providing on-floor cGMP production support.

Analytical equipment maintenance and process development. Compliance with pharmaceutical production SOPs to ensure quality control for fermentation and harvest.