John Statler Email & Phone Number

Pharmaceutical consultant with particular expertise in the Quality functional area, helped start-up and early-phase companies achieve success. Guided clients in the establishment of efficient Quality systems and procedures. Advised clients on effective CMC strategies for product development, regulatory submissions, and agency inspections. Audited clients’ suppliers and service providers to ensure GMP and GLP compliance. Conducted due diligence of new product-development opportunities.

Led groups responsible for analytical development, QC, stability, and contract laboratory management. Audited, qualified, and transferred technology to contract laboratories. Wrote and reviewed Quality sections of numerous successful INDs, NDAs, and corresponding international submissions. Led multidisciplinary project team through the final stages of regulatory approval and product launch. Represented CMC in face-to-face meetings with regulatory authorities. Conducted due-diligence reviews and CMC assessments of potential in-licensing opportunities.

Reported to President/CEO. Led all Quality operations, including QA, QC, and Analytical Development. Served on the Executive Committee, setting company direction. Created corporate QC Lab. Led team that created and implemented a fully-operational cGMP Quality System in 3 months. Created and submitted Quality sections of successful IND and IDE.

Directed scientists in biological, pharmaceutical, environmental, and industrial HPLC, IC, and CE method development. Guided creation of ISO 9000 Quality procedures and audited other departments, encouraging continuous improvement. Created a Product Evaluation group to improve product reliability and generate proof of performance.

Directed chemists in the discovery and development of novel, metal-based and other hetero-atom-based compounds as candidates for antiviral, antifungal, and antiinflammatory agents. Directed collaborations with pharmaceutical partners, reporting progress at joint project team meetings.

Ph.D., Chemistry

Bs, Chemistry | Bs, Secondary Education

Nato Postdoctoral Fellowship, Chemistry