Head of Analytical and QC group. Responsible for all analytical and QC activities in support of tesetaxel development. Includes management and oversight of external partners involved in production of regulatory starting materials, intermediates and API and drug product and associated development activities.

Led the analytical team in CMC/drug product development supporting all projects in clinical development. Responsible for directing and executing analytical research to support the synthesis and formulation development of drug candidates. Plan, design and implement analytical experiments for the characterization of drug substances and drug products. Direct research associates and members of project teams in the initiation and execution of laboratory experimentation. Prepare CMC sections of… Show more Led the analytical team in CMC/drug product development supporting all projects in clinical development. Responsible for directing and executing analytical research to support the synthesis and formulation development of drug candidates. Plan, design and implement analytical experiments for the characterization of drug substances and drug products. Direct research associates and members of project teams in the initiation and execution of laboratory experimentation. Prepare CMC sections of regulatory filings and respond to questions from regulatory agencies/health authorities. Oversee development and GMP/QC activities at contract research/testing labs. Show less

Responsible for oversight of all analytical activities for API and drug product development for Tozadenant clinical development program. Includes management and oversight of external partners (CROs, CMOs), CMC content of regulatory filings and NDA enabling activities.

Managed up to 24 scientists in the Analytical Operations group within Pharmaceutical Development and Manufacturing at Gilead Sciences who are responsible for analytical functions (GMP) of development programs from PhI through commercialization. Oversaw the analytical activities and CMC sections for three approved HIV combination therapies (two, three and four drug single tablet regimens) Descovy, Odefsy and Genvoya. General responsibilities include: directing and executing analytical research… Show more Managed up to 24 scientists in the Analytical Operations group within Pharmaceutical Development and Manufacturing at Gilead Sciences who are responsible for analytical functions (GMP) of development programs from PhI through commercialization. Oversaw the analytical activities and CMC sections for three approved HIV combination therapies (two, three and four drug single tablet regimens) Descovy, Odefsy and Genvoya. General responsibilities include: directing and executing analytical research to support the synthesis and formulation development of drug candidates and the research support of marketed drugs. Plan, design and implement analytical and spectroscopic experiments to advance scientific knowledge and characterization of drug substances and drug products. Direct research associates and members of project teams in the initiation and execution of laboratory experimentation, considering regulatory, compliance and safety factors. Serve on inter-departmental and cross-functional teams responsible for CMC project deliverables and timelines. Prepare CMC sections of regulatory filings and respond to questions from regulatory agencies/health authorities. Oversee development and QC activities at contract research/testing labs. Show less

Managed a group of scientists in the Analytical and Bioanalytical Development department within the Pharmaceutical Development division of Bristol-Myers Squibb Research. Responsible for analytical activities for GMP API and DP development including method development and validation, testing and release, stability studies, specifications, regulatory filings and agency questions and method transfers.

Directed and supervised scientists responsible for performing analytical activities in support of formulation and drug product development. Responsibilities included: experimental design, method development and troubleshooting, data review and reporting (internally and externally), protocol writing, review and approval, project and resource management, client communication and presentations. Developed and validated analytical methods for drug product; tested and released clinical supplies;… Show more Directed and supervised scientists responsible for performing analytical activities in support of formulation and drug product development. Responsibilities included: experimental design, method development and troubleshooting, data review and reporting (internally and externally), protocol writing, review and approval, project and resource management, client communication and presentations. Developed and validated analytical methods for drug product; tested and released clinical supplies; performed stability studies; characterized prototype formulations for NCEs and ANDAs; prepared validation and stability protocols and reports, project progress reports and presentations. Show less

Analytical chemist involved with GMP API process development within R&D. Activities included development and validation of methods for in-process support of scale-up and pilot plant batches (testing for end-of-reaction, raw materials and intermediates) and API release including chromatographic, spectroscopic and titration methods. Extensive experience with HPLC for assay and impurities, chiral HPLC for enantiomer and diastereomer levels, GC for residual solvent determinations and LC/MS for… Show more Analytical chemist involved with GMP API process development within R&D. Activities included development and validation of methods for in-process support of scale-up and pilot plant batches (testing for end-of-reaction, raw materials and intermediates) and API release including chromatographic, spectroscopic and titration methods. Extensive experience with HPLC for assay and impurities, chiral HPLC for enantiomer and diastereomer levels, GC for residual solvent determinations and LC/MS for impurity and degradant identification. Also responsible for API stability studies, specification setting and regulatory filings. Show less