With a background in synthetic chemistry and over 25 years of delivering chemical development and manufacturing solutions to a wide range of Pharma and Biotech clients within a fast-paced outsourced R&D environment, I understand the unique constraints and challenges faced by innovators and opportunities available to them for leveraging the expertise and capabilities from outside service providers to accelerate their drug development programs. I assist busy entrepreneurs, startups, and emerging life sciences companies (therapeutics, diagnostics, medical devices), including virtual Pharma, in identifying service providers with the most fitting know-how, capabilities and capacity for implementing phase appropriate process development and manufacture of active pharmaceutical ingredients. Additionally, I provide project management services for outsourced chemistry, and consulting services for chemical development and regulatory CMC.Specialties: • Sourcing expert chemistry R&D and manufacturing services• Chemistry R&D leadership and project management• Process development and optimization for active ingredients and intermediates• Drug substance physical form screening, selection and optimization• Crystallization process development and optimization • Integration of biocatalysis with traditional synthesis methodologies• CMC consulting• Writing and editing CMC section of regulatory filing dossiers (IND, NDA, IMPD)
Listed skills include Organic Chemistry, Technology Transfer, Chemistry, Gmp, and 22 others.