Quality CMC Consulting helps pharma/biotech/medical device clients with virtual CMC related activities at outsourced vendors from pre-IND to commercial stages. Experienced in CMC Operations (PM, formulation & testing development, manufacturing, supply chain, and regulatory) and Quality (QC/QA). Examples of projects completed:• Acted as a Quality/CMC representative on small molecule and biologic projects at different stages in development (pre-IND to commercial) for intermediates, drug substances, and various drug product forms such as: lyophilized injectable (biologic), liquid injectable (small molecule), ophthalmic injectable (small molecule), oral solids & liquids (small molecule), and semi-solid (small molecule). • Served as the Client’s Quality representative to bring a lyophilized biologic product back on the US market. This involved due diligence audits, vendor selection, formulation development, process and method development, process and method validation, comparability exercises, and Pre-Approval Inspection activities at both the drug substance and the drug product CMOs, all of which were in the EU. The cardiac drug received FDA approval in 2017. • Served as a primary author for client reports and regulatory submissions: INDs, BLAs, NDAs, DMFs, and Annual Reports.• Authored and executed Quality Agreements for Phase 1 to Commercial programs.• Served as the SME to a multibillion dollar, global company on a marketing research project with the goal to investigate how to best optimize an outsourced CMC business offering.• Worked with start-ups to optimize their CMC development plans and vendor selection to aid in fundraising activities. • Provided vendor selection, PM, and Quality support for a Non-Profit and Government Organization (Phase IV)• Performed a gap analysis on a client's commercial SOP system to support clinical development.• Built a Quality Management System • Conducted audits: due diligence, re-qualification, and PAI support.

The Parenteral Drug Association's Southeast Chapter (PDASE) provides and disseminates information relating to technology in the pharmaceutical, medical device, biotechnology, and clinical industries by promoting high manufacturing standards and encourages the sharing of scientific and technical knowledge.More info: https://www.pda.org/chapters/north-america/southeast

The Astronaut Scholarship Foundation is governed by a team of industry leading professionals whose talents and experiences drive ASF's policies, objectives and overall direction to support the very best and brightest scholars in science, technology, engineering and mathematics.https://astronautscholarship.org/boardofdirectors.html

The Program Committee provide leadership, strategy, and guidance for the implementation and improvement of ASF Programs. The mission of ASF is to aid the United States in retaining its world leadership in technology and innovation by supporting the very best and brightest scholars in science, technology, engineering, and mathematics while commemorating the legacy of America’s pioneering astronauts.

Provide CMC assistance on due diligence assessments and to BTIF portfolio companies.

Activated Research Company (ARC) is MAKING CHEMICAL ANALYSIS EASY™ while improving accuracy, saving time, and reducing costs in the laboratory. For decades scientists have relied on detectors with variable response and standards with questionable accuracy. ARC develops instruments and tools that give scientists accurate chemical quantification.

2014 Past Chair2013 Chair2012 Past Chair2011 Past Chair2010 Chair2009 Program Chair2008 Treasurer