Morgan T.
Senior Manager, CMC Operations @ Kailera Therapeutics
United States
San Diego
Pharmaceuticals
Regulatory Compliance, Continuous Process Improvement, Manufacturing, Quality System, Leadership, Management, Team Management, Laboratory Skills, Standard Operating Procedure (SOP), Product Development, Project Coordination, Food Safety, Product Innovation, Quality Control, Quality Management, Formulation, GMP, Pharmaceutics, HPLC, Pharmaceutical Industry
Experience

Director of Quality and Innovation
San Diego, California
*Independently built successful quality and innovation programs, commissioned all laboratory equipment, developed all laboratory SOPs, developed a microbiology testing program for shelf-stable product, onboarded and managed six full-time employees across two departments *Formulated and scaled 37 unique new beverage recipes across two product lines from bench to market for the largest independent craft brewer in Southern California, with product sales generating an annual revenue of >$30 million *Worked closely with compliance to ensure adherence to legal specifications including nutritional and ingredient labeling, COLA submissions, USDA organic certifications, Kosher certifications, and GFCO gluten-free certifications *Coordinated with team leaders in supply chain, sales, operations, and production to ensure timely success of new innovation initiatives *Worked with finance to monitor cost of goods, tracked related KPIs to maintain target profit margins

Senior Pharmaceutical Chemist
San Diego, CA
*Autonomous project management of non-clinical and Phase I/II pharmaceutical development projects including preformulation, HPLC analytical method development, formulation development, GMP test method development, GMP stability studies, and batch record review to support manufacturing and testing of clinical drug product *Drafted service agreements and work orders to cover work with new and existing clients, provided weekly billing updates to accurately invoice milestone completions *Managed multiple full-time chemists and laboratory assistants

Organic Chemistry Group Tutor / TA
University of California, Santa Barbara
Conducted bi-weekly sections for groups of 20-30 students. Wrote weekly lesson plans to cover important lecture topics. Served as a liaison between students and professor. Prepared study guides and conducted large review sessions before important exams. Also provided one-on-one tutoring to those in need.
Morgan T.'s Contact Information
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