Greg Democko Email & Phone Number

Raleigh-Durham, North Carolina Area

Manage outsourced analytical testing and associated budget at multiple CROs to maintain relationships, project deliverables and timelines. Analytical project lead for oral suspension project being developed/manufactured at CMO. Manage analytical testing activities for method development, validation and batch release of oral suspension drug product at CMO. Critically review, tabulate, and interpret analytical data. Provide guidance for lab investigations. Develop and successfully execute analytical experiments.

Raleigh-Durham, North Carolina Area

Provided oversight for outsourced analytical testing and stability studies at third party CMOs/CROs. Developed protocols for NDA/MAA registration and development API and drug product stability studies. Reviewed analytical method validation protocols and validation reports from third party contract vendors for compliance with ICH guidelines. Monitored stability data generated at third party contract vendors for trends and atypical results.

Research Triangle Park, Nc

Provide analytical support for development of new fixed dose combination drug product for Asia markets by developing and validating dissolution methods to meet Japanese Pharmacopeia requirements (nine dissolution medium). Performed analytical testing on development and stability samples (dissolution, content/impurities by HPLC).

Research Triangle Park

Managed a group of analysts in stability testing laboratory supporting Phase II/III drug product and API projects. Analytical project lead for multiple solid oral dose formulations for HIV, diabetes and cancer treatments. Responsible for method transfers, scheduling/planning of analytical testing, report/evaluate stability data and staff performance/development. Authored/reviewed CMC sections for regulatory filings, e.g. stability tables, analytical methods, method validations.

Research Triangle Park

Analytical project lead for a new combination oral solid dosage formulation for treatment of HIV infection. Directed activities by coordinating method development and validation activities and transfer of methods to GSK manufacturing sites for commercialization. Assessed stability data for trends. Authored validation/transfer protocols, technical reports and CMC sections of NDA/MAA submissions. Performed analytical testing (dissolution, HPLC, KF).

Durham, Nc

Provided analytical support for API and oral solid dosage products under development for HIV/HBV infections by validating and transferring analytical methods. Perform analytical testing for API process development and API/drug product stability.

Research Triangle Park, Nc

Greenville, Nc

Paris, Ky