Okapi Chemtech provides chemical development/CMC consulting services, sourcing of contract R&D and manufacturing services for active pharmaceutical ingredients and project management services, including:• Synthesis route assessment, process development, optimization and scale-up• Review of CMC readiness/gap analysis, taking into account the clinical development stage and timelines• Planning and executing phase appropriate chemical development, mitigating risks for drug substance being on the critical path• Developing a coherent plan for solid state development (salt/polymorph screening and selection) and crystallization development to ensure a robust manufacture of the drug substance and intellectual property coverage• Drafting/editing CMC section of regulatory filing dossiers, annual reports• Troubleshooting chemistry and crystallization scale-up issues during manufacture • Review/organization of technical packages; generation of RFI/RFP/RFQ as appropriate• Vendor engagement, review proposals and assist in selection of best sourcing option • Facilitate and execute tech transfer • Assist in defining project requirements (scope, timelines, milestones, etc)• review and edit reports as neededI work closely with your in-house drug development team and third party subject matter experts (formulation, regulatory, QA, engineering) to ensure that the chemical development activities are well aligned with the overall drug development plan.

Leadership of a diverse team of chemists to implement a wide range of outsourced chemistry R&D projects from Pharma, Biopharma, Biotech and Specialty Pharma customers, including process development and optimization, salts and polymorphs screening, crystallization process development and optimization for polymorph control and particle engineering, custom synthesis of APIs and technology transfer of processes for pilot manufacture of bulk active pharmaceutical ingredients (APIs) intended for IND-enabling toxicological evaluation and Phase I - III clinical evaluation as required by cGMPs, ICH and FDA guidance and regulations.Project management; coordination of cross-functional project teams (chemical development, QA, GMP, engineering).Synthesis route design; process development and optimization, technology transfer for kilo-lab and pilot scale manufacture of APIs and intermediates; custom synthesis of diversely functionalized scaffolds for Medicinal Chemistry

Graduate research in organic synthesis, biocatalysis and total synthesis of natural productsTeaching general organic chemistry lab

Lectured on general organic chemistry, reaction mechanisms and synthesis. Hands-on laboratory training of chemistry, pharmacy and medical school students