Experience

ChemoCentryx

• United States
• Biotechnology Research
• 1 - 100 Employee

• Sr. Vice President, Technical Operations

  • Mar 2020 - Present

  • Provide strategic direction as a member of the Senior Management team • Built a high functioning Technical Operations team of consisting of Pharmaceutics, drug substance and drug product development, process and analytical development, manufacturing, Quality, end to end supply chain, CMC lifecycle management and program management • Successfully advanced Tavneos for ANCA Vasculitis to global regulatory approvals (U.S., Japan, EU, Canada); Successfully led the commercial manufacturing team to launch and commercial distribution; Advanced avacopan for Phase 3 trials in Lupus Nephritis and Hydradenitis Suppurativa • Advanced clinical candidates (CCX507, CCX111 and CCX559) into various phases of clinical development Show less



Spruce Biosciences

• United States
• Biotechnology Research
• 1 - 100 Employee

• Vice President, Pharmaceutical Development and Manufacturing

  • Nov 2018 - Mar 2020

  • Reporting to the CEO, responsible for all aspects of Technical Operations to support clinical development of Tildacerfont for rare disorders including Congenital Adrenal Hyperplasia • Lead and oversee global network of drug substance, drug product, & Packaging CMO’s. Functional responsibilities include Development, Manufacturing, QA, Supply Chain, Process Development, Technology Transfer, QC, Contract Negotiation, Project Management and Project Budgeting. • Advanced Tildacerfont development through Phase 2 trials • Implemented Phase appropriate Quality System with Quality Manual, Directives and SOP to ensure compliance with relevant GxP requirements. • Executive Team Member helping shape the growth of the company; standing participant at Board of Directors meetings. • Completed strategic review of existing manufacturing and supply chain network against future requirements. Show less



Adamas Pharmaceuticals, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Vice President, Pharmaceutical Development

  • Jan 2015 - Oct 2018

  • Provide strategic direction, tactical oversight and technical expertise to CMC department consisting of formulation development, process development, analytical development, bio-analytical sciences, contract manufacturing, clinical supplies, commercial scale development and manufacturing and packaging • Development of Gocovri®, Namzaric® and other pipeline programs at outsourced manufacturers including vendor selection, technology transfer, formulation development, commercial scale manufacturing, analytical and bioanalytical methods and stability for drug substance (API) and drug product• Collaborate with Regulatory Affairs, Clinical Development, Nonclinical Development and Commercial groups to define and execute appropriate CMC strategies to support Adamas’ small molecule development pipeline • CMC discussions with FDA, Forest Laboratories and Actavis• Budgeting and financial planning for pharmaceutical development activities ( $15 MM) Show less

• Senior Director, Pharmaceutical Development

  • Nov 2012 - Feb 2015

  • Responsible for Formulation Development, Process Development, Commercial Scale-Up, Analytical Development, Bioanalytical Development and Contract Manufacturing. Responsible for Clinical Manufacturing, Supply Chain, Packaging and Distribution,



Transcept Pharmaceuticals, Inc.

• Senior Director, Product Development

  • May 2012 - Oct 2012

  • Head of product development group responsible for the development of Transcept’s pipeline candidates • Extend Transcept’s pipeline with new candidates/programs • Commercial scale manufacture of Intermezzo® • Head of product development group responsible for the development of Transcept’s pipeline candidates • Extend Transcept’s pipeline with new candidates/programs • Commercial scale manufacture of Intermezzo®



Anthera Pharmaceuticals

• United States
• Biotechnology Research
• 1 - 100 Employee

• Director, CMC Operations

  • Sep 2011 - Apr 2012

  Responsibility of all CMC activities and global clinical supply chain management for Varespladib methyl program for Acute Coronary Syndrome (ACS) Led drug substance and drug product manufacturing, formulation development, process development, analytical sciences and validation capabilities for Varespladib methyl program. Commercial scale manufacturing of Varespladib drug substance (US and Asia) and drug product for Phase 3 study (VISTA-16) Extensively managed contract manufacturers worldwide, contract research organizations, drug substance manufacturers, packaging and labeling vendors, excipient suppliers Represented Anthera as the CMC liaison to the FDA at the end of Phase 2 meeting Responsible for global clinical supply chain for VISTA-16 trial (phase 3, 16 countries, 6 depots) for ACS Resolved tough technical challenges in drug product manufacturing leading to a robust, commercially viable manufacturing process for Varespladib tablet (250 mg) Led formulation development for second generation Varespladib methyl tablet (500 mg tablet) Negotiated supply agreements and quality agreements with drug substance and drug product manufacturers Led life cycle planning, intellectual property strategy and launch presentation Partnered with Clinical Operations, Regulatory, Quality and Corporate development groups Show less



Transcept Pharmaceuticals, Inc.

• Director, Formulation Development

  • Feb 2011 - Jul 2011

  Leadership role in technical projects; Formulation development of novel solid oral dosage forms, extended release oral suspension formulation, lead optimization, technology transfer to CMO Build Transcept intellectual property through creative ideas in product formulation and by developing new product concepts Leadership role in technical projects; Formulation development of novel solid oral dosage forms, extended release oral suspension formulation, lead optimization, technology transfer to CMO Build Transcept intellectual property through creative ideas in product formulation and by developing new product concepts



Transcept Pharmaceuticals

• Associate Director, Product Development

  • Dec 2008 - Jan 2011

  Author CMC sections of IMPD for Intermezzo® and IND for pipeline products (TO-2061)Responsible for the manufacture of Ph I and II clinical trial material (CTM) for insomnia studies; Formulation development and Ph I CTM for Obsessive Compulsive Disorder. Clinical operations responsibilities including packaging and labeling for two complex double blind, double dummy cross-over studies in US and Europe. Import/export/release of CTM (controlled substance) in Europe. Work with senior management on FDA submission strategies and long-term strategic planning Show less

• Group Leader, Formulation Development

  • Nov 2008 - Nov 2009

  Author CMC sections in Intermezzo® NDA (eCTD format) and IND for pipeline candidate for obsessive compulsive disorder. Responsible in a cross company development of process, production and DMF of non-compendial excipient critical to Intermezzo® formulation. Management of the project, technology transfer between vendors, method and process validation activitiesIdeation and animal studies as proof-of-concept for an anticholinergic drug for the treatment of depressionNovel controlled release formulation for pipeline program for treatment of obsessive compulsive disorder Show less

• Lead Formulations Scientist -Pharmaceutical Sciences

  • Nov 2007 - Nov 2008

  Project leader for an injectable product for the treatment of major depressive disorder successfully taking it under tight timelines from ideation to formulation selection. Responsibilities include ideation, overall project plan including cost, timelines, acquire management approval, lab set up for parenteral work with cytotoxic API, preformulation, lead selection, optimization and stability under ICHLead several in-house development studies that were part of the product development sections of Intermezzo® NDADevelopment of alternate formulation of Intermezzo® Show less



InBios International

• Medical Equipment Manufacturing
• 100 - 200 Employee

• Sr. Scientist

  • Jan 2005 - Oct 2007



ALZA, Johnson & Johnson

• Sr. Scientist

  • 2004 - 2007



Biozone Laboratories

• Sr. Scientist

  • Feb 2001 - Nov 2004



University of Florida, Gainesville

• Post-doctoral Fellow

  • 1999 - 2001