Sacramento, California, United States
Accomplished Director and Project Manager with 9+ years experience in manufacturing, supply chain, and quality operations. Proven expertise in leading cross-functional teams, optimizing operational efficiency, and driving strategic initiatives within regulated industries. Skilled in cGMP compliance, technology transfer, and scaling novel therapeutic compounds from R&D to commercial production. Adept at managing complex supply chains, ensuring product quality through robust QC testing, and building partnerships with CDMO/CMO, CRO, CLO networks to deliver cost-effective, high-quality solutions. A results-driven leader with a track record of success in both start-ups and established organizations, consistently achieving business objectives and fostering innovation.
•Directed Manufacturing, Quality, Supply Chain, R&D, and EH&S operations, securing $7M+ in capital by achieving key project milestones ahead of schedule. •Established cGMP standards, manufacturing scale-up processes, and tech transfer protocols for synthetic therapeutic compounds in commercial production. •Led process optimization experiments, improving yields by 30%+ and reducing waste by 50%, while developing a supply chain strategy that cut procurement costs by up to 35%. •Integrated operations into an ISO 9001-compliant QMS and ERP system. •Established global partnerships and supply chains with CLOs, CMOs, and CROs to enhance manufacturing capabilities, R&D timelines, supply chain reliability, and product quality. •Managed projects and communication through tools like Monday.com and Asana, establishing KPIs for accountability and stakeholder visibility.
•Oversaw 300+ Next-Generation Sequencing (NGS) and bioinformatics projects for clients, including Tier 1 research universities and biotech/pharma companies in the Southeast USA. •Managed client relationships and project timelines across internal teams (QC Sequencing Lab, Shipping/Receiving, Bioinformatics, IT, QA) and external CROs for outsourced sequencing projects.
•Drove revenue growth from $0 to $2M+ annually by overseeing Manufacturing, Quality, Supply Chain, R&D, and EH&S operations •Spearheaded the launch of 20+ product SKUs, including functional ingredients, beverages, gummies, and nano-encapsulated cannabinoid liquids and powders with metric-ton output capacity. •Established cGMP standards, scale-up, process optimization, and tech transfer protocols, building a robust manufacturing and quality pipeline with CMOs, CROs, and CLOs. •Contributed to tech sales, B2B/B2C business development, marketing, and package and website design.
•Supported process development, validation, MSAT scale-up, and tech transfer for the Class 1 DIV 2 facility startup of the Nimenrix vaccine drug substance (DS) manufacturing plant. •Managed supply chain of consumables and operated process equipment used during engineering, demo, and PV batch campaigns, collaborating with teams such as Tech Ops, MSAT, Automation, Calibration, Warehouse, and Maintenance. •Served as the EH&S lead for Nimenrix purification group. •Authored and revised SOPs, work instructions (WIs), job aids, buffer compound records, and master batch production records for the purification of polysaccharide serotypes (A, C, W, Y) and deactivated-tetanus components.
•Operated aseptic manufacturing process equipment in Grade A/ ISO class 5, for 2K and 15K modular purification suites, producing both Drug substances (DS) and Drug products (DP). •Supported purification and final fill of Phase 1-3 clinical trial material, as well as commercial products. •Conducted on the floor sampling and testing of process intermediates and final product characterization. •Contributed to the production of medications, including Alprolix, Eloctate, Darzalex, and Aducanumab.