Experience

AN2 Therapeutics

• United States
• Biotechnology Research
• 1 - 100 Employee

• Vice President, CMC

  • Feb 2022 - Present

• Sr. Director, Drug Product Development

  • May 2021 - Feb 2022

  Menlo Park, California, United States



PellePharm

• United States
• Biotechnology Research
• 1 - 100 Employee

• Sr. Director of Drug Product Development

  • Mar 2021 - May 2021

  San Francisco, California, United States

• Director of Drug Product Development

  • Jul 2017 - Mar 2021



Anacor Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Associate Director, Process Development

  • Aug 2012 - May 2017

  Palo Alto, CA • Launched two commercial topical drug products: Eucrisa™ and Kerydin®. • Authored NDA drug product sections (all formulation, process, and packaging sections) for Eucrisa NDA. Reviewed all drug product and drug substance sections of Kerydin NDA for QC and consistency. • Managed CMOs through coordinating meetings, developing protocols, writing master batch records, and overseeing production. • Directed the manufacturing process development plan, from Phase II through scale-up, Phase… Show more • Launched two commercial topical drug products: Eucrisa™ and Kerydin®. • Authored NDA drug product sections (all formulation, process, and packaging sections) for Eucrisa NDA. Reviewed all drug product and drug substance sections of Kerydin NDA for QC and consistency. • Managed CMOs through coordinating meetings, developing protocols, writing master batch records, and overseeing production. • Directed the manufacturing process development plan, from Phase II through scale-up, Phase III, ICH registration lots, validation lots, and commercial launch. • Developed validation (process, packaging, cleaning) protocols, oversaw execution, and approved reports. • Developed specifications for finished products, critical excipients, and packaging components. • Designed, executed, and performed statistical analysis for excipient property DOE. • Performed process scale-up and site transfer for established process to new manufacturer and equipment. Show less



Dharma Therapeutics

• Senior Engineer

  • Sep 2008 - Feb 2012

  Seattle, WA • Developed iontophoretic drug products, including the semisolid formulations, device components, and manufacturing processes. • Collaborated with CMOs to develop and optimize manufacturing processes, write master batch records, train personnel, and manufacture Phase II GMP clinical supplies. • Provided review and oversight of medical device configuration, design specifications, and drawings. • Optimized formulation compositions with respect to manufacturability, stability, and… Show more • Developed iontophoretic drug products, including the semisolid formulations, device components, and manufacturing processes. • Collaborated with CMOs to develop and optimize manufacturing processes, write master batch records, train personnel, and manufacture Phase II GMP clinical supplies. • Provided review and oversight of medical device configuration, design specifications, and drawings. • Optimized formulation compositions with respect to manufacturability, stability, and subsequent processability. • Developed a viscous fluid dispensing process, solving complex heat and mass balance challenges. • Developed IP for novel gels exhibiting temperature-induced phase separations, and their related dispensing characteristics. Show less



Johnson & Johnson

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Engineer III, Engineer II, Engineer I

  • Jun 2001 - Aug 2008

  Mountain View, CA • Participated in several drug product development programs for passive and active (iontophoretic) transdermal drug products. • Served as the Technical Lead for the development of a novel 7-day transdermal bisoprolol drug product, overcoming exceptionally high dosing requirements. • Collaborated with a biomedical adhesive supplier to reformulate adhesive chemisty to uniquely suit formulation requirements. • Served as the Technical Lead for the development of a novel 7-day… Show more • Participated in several drug product development programs for passive and active (iontophoretic) transdermal drug products. • Served as the Technical Lead for the development of a novel 7-day transdermal bisoprolol drug product, overcoming exceptionally high dosing requirements. • Collaborated with a biomedical adhesive supplier to reformulate adhesive chemisty to uniquely suit formulation requirements. • Served as the Technical Lead for the development of a novel 7-day transdermal norelgestromin drug product. • Coordinated high-throughput screening program to identify lead formulations from thousands of candidates. • Authored technical reports and assisted with NDA preparation. • Managed Phase I clinical production of a unique transdermal opioid formulation. • Provided physical characterization support (DSC, TGA, Rheology) in formulation development. Show less