Tyler Westcott Email & Phone Number

Menlo Park, California, Us

Menlo Park, California, Us

San Francisco, California, Us

San Francisco, California, Us

Palo Alto, Ca, Us

• 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.

• 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.

New Brunswick, Nj, Us

• Participated in several drug product development programs for passive and active (iontophoretic) transdermaldrug 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 suitformulation 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.