Experience

Mast Therapeutics, Inc.

• Biotechnology Research
• 1 - 100 Employee

• Sr. Director, Quality Assurance

  • aug. 2012 - - Prezent

  Responsible for Quality Assurance functions in support of a Phase III program for a sickle cell disease therapy. Oversee GMP contract manufacturing at several firms in Europe, including development of batch records, process validation, facility qualification, QC testing, development and approval of API and drug product specifications, review of deviations and investigations, and disposition of product. Responsible for Quality Assurance functions in support of a Phase III program for a sickle cell disease therapy. Oversee GMP contract manufacturing at several firms in Europe, including development of batch records, process validation, facility qualification, QC testing, development and approval of API and drug product specifications, review of deviations and investigations, and disposition of product.



Ludwig Cancer Research

• Research Services
• 100 - 200 Employee

• Product Control Officer

  • ian. 2008 - iul. 2012

  Ensure regulatory compliance at LICR-Cornell Biological Production Facility and at the Melbourne Australia Biologics Distribution Facility and at CMO’s and related organizations. Provide technical oversight of clinical supply manufacturing, testing and distribution. Implement SOPs and Quality Systems to ensure ongoing compliance. Responsible for quality of finished investigational materials, including release of materials to the clinic. Ensure regulatory compliance at LICR-Cornell Biological Production Facility and at the Melbourne Australia Biologics Distribution Facility and at CMO’s and related organizations. Provide technical oversight of clinical supply manufacturing, testing and distribution. Implement SOPs and Quality Systems to ensure ongoing compliance. Responsible for quality of finished investigational materials, including release of materials to the clinic.



Accentia Biopharmaceuticals

• General Manager

  • sept. 2005 - dec. 2007

  General Manager, Vaccine Operations, Biovax, (7/07-1/08)Responsible for overall plant operations, including leadership of Biovax Non-Hodgkin's Lymphoma vaccine development program, manufacture of vaccines for use in clinical trials, process and analytical development, oversight of the quality program, and development/implementation of commercial manufacturing strategies. Coordinate Phase III clinical trial activities with NCI under a CRADA. • Annual budget responsibility of approximately $15MM. • Manage 42 individuals.Executive Director, Regulatory Affairs & Quality Assurance (9/05-6/07)Senior Regulatory Affairs executive, responsible for all interactions with Regulatory Agencies concerning products under development. Assumed direct responsibility for product development and pharmacokinetic/toxicology studies for Accentia’s lead product, SinuNase. Managed 3 individuals.• Revived stalled development program for SinuNase, allowing for initiation of a pivotal Phase III trial within 12 months of starting employment. • Implemented Quality Systems to ensure GXP compliance for clinical studies, CTM manufacture, and pharmacokinetic/toxicology studies. • Managed the activities of multiple contractors performing product, process, and analytical development, clinical supply manufacturing, clinical research and pharmacology/toxicity testing programs.



Purdue Pharma L.P.

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Director, Corporate Quality Assurance

  • apr. 2003 - sept. 2005

  Responsible for formation of the corporate Quality GMP/GLP Compliance group, and development and implementation of Quality and compliance programs for API and drug product manufacturing. Managed 6 individuals. Responsible for formation of the corporate Quality GMP/GLP Compliance group, and development and implementation of Quality and compliance programs for API and drug product manufacturing. Managed 6 individuals.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director, Compliance Operations

  • ian. 2000 - apr. 2003

  Provided leadership and oversight of Quality compliance programs at the Marietta manufacturing site. Managed Quality/GMP compliance programs at the Wyeth Marietta manufacturing site (approximately 1400 employees). Provided leadership and oversight of Quality compliance programs at the Marietta manufacturing site. Managed Quality/GMP compliance programs at the Wyeth Marietta manufacturing site (approximately 1400 employees).