Develop scope, goals and risk /gap analysis for technical development of pharmaceutical
products integrating both development and commercial expectations, available resources,
current technical information and current business issues. Designed for demands of small and
emerging pharmaceutical companies.
API PROCESS SCALEUP AND ORGANIC CHEMISTRY
Solve chemistry problems of APIs, interactions with excipients, plastics and metals,
manufacture and scale-up.
ANALYTICAL CHEMISTRY
Experience in analytical method development and validation for APIs and drug products;
setting test specifications for clinical and commercial products and evaluating new and
potential impurities. Additional experience in validation of bioanalytical methods and biological
assays for pre-clinical and clinical support.
CONTRACT MANUFACTURING
Select and manage cGMP contract manufacturers of intermediates and active pharmaceutical
ingredients (APIs) including technology transfer, scale-up activities, process problem solving,
contract development, specification setting , development and transfer of analytical methods ,
batch record review and stability study protocol review.
PARENTERAL PRODUCTS
Experience with liquid in vials, flexible plastic containers and syringes, and solid powder filling;
formulation, sterilization, packaging assessments, leachables, container integrity evaluations.
REGULATORY
Drug Master File and Chemistry, Manufacturing and Controls sections for INDs and final
regulatory submissions. Common Technical Document.
SHARED PROJECT DEVELOPMENT ENVIRONMENTS
Successfully work in collaborative and demanding environments of joint ventures, small/large
company shared projects, in-licensing, university and industry consortia collaborations.
INTERNATIONAL PRODUCT DEVELOPMENT EXPERIENCE
Interactions with European manufacturers of APIs and parenteral solutions; European and
Australian regulatory authorities
TECHNOLOGY TRANSFER DURING IN-LICENSING
Effectively extract critical data from licensor to obtain optimum value to licensee during
information transfer periods.
SPOKEN LANGUAGES AND COMPUTER SOFTWARE
Fluent in French, minimal German. Qumas DocCompliance(document management software),
local ISISBase (chemical and biological information database), Microsoft Project,
