Charles Ogindo
Founder @Xchem Inc
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WORK HISTORY
Founder @Xchem Inc
Founded Xchem Inc, a Contract Research Organization (CRO) laboratory that develops analytical technologies and drug product intermediates in support of precision drug development such as monoclonal antibody-drug conjugation (ADCs) for anti-cancer therapy, antisense small interference ribonucleic acid linkers (siRNA) for gene expression modulation. RNA delivery facilitation via lipid phosphoramidite construction. • Designed and optimized synthesis of 3-sulfo N-hydroxysuccinimide activated maeleimidocaproyl linker, with a purity of 98% that avoided the use of chromatographic separation, with a batch size of 20 g; Synthesized RNA conjugation ligands such as Diels-Alder protected maleimido alkyl phosphoramidite derivatives.• Expertise level synthesis skills; route scouting, literature search using databases such as Scifinder, reaxys and journals articles. Ability to design scalable synthetic routes and to perform compound purification via extraction, crystallization, and chromatography. • Built Laboratory infrastructure: instruments acquisition, inventory build-up and data management systems. Performed budgeting and resource allocation for product research and development, and marketing.• Created method development strategies for small molecules and biologics and validation protocol templates based on HILIC, HIC and normal phase chromatography.
EDUCATION
Kenyatta University
Bachelor’s Degree, Chemistry
Howard University
Doctor of Philosophy (Ph.D.), Medicinal and Pharmaceutical Chemistry, Organic Synthesis, Computational Biology
Binghamton University
Graduate Research, Chemistry; Organometallic Chemistry
ABOUT CHARLES OGINDO
Multi-disciplinary scientist with expertise level experience in organic synthesis, analytical and bioanalytical method development and qualifications, experience with CMC analytical method qualification strategies including defining CQAs, analytical risk analysis and mitigation, establishing quality specifications and regulatory submission strategy.• Identification and creation of effective partnerships with stakeholders from R&D, Analytical Development, Method Validations, Manufacturing Sciences and Technology, Supply Chain, Regulatory, Quality, Drug Product Development, Project Management and Manufacturing to deliver analytical strategies with a high degree of technical and regulatory success.•Advanced technical expertise in analytical and bioanalytical method platforms such as N-Glycan profiling for mAbs/Fusion proteins, Purity analysis by Non-Reducing and Reducing CE-SDS, charge-variant estimation by imaged capillary isoelectric focusing (iCIEF), Methionine oxidation analysis by UV, Peptide mapping, residual DNA, potency (ELISA), etc. •Hands-on experience in methods development based on instruments GC, LC, LC-MS, CE-SDA, iCIEF, etc, and various detectors such as mass spectrometer, fluorescence detectors, charged aerosol detectors (CAD), Photodiode-array detector (PDA), Flame Ionization Detector (FID), etc, and the pertinent data acquisition and processing software, including Empower, OpenLabs and SoftMax.•Knowledge in monograph methods of US and European Pharmacopeia, FDA method validation guidelines, ICH harmonized guidelines for analytical and biotechnological/biological products specifications (ICH Q6A/Q6B) and Analytical validation guidelines (Q2(R2)/Q14). Over 20 years of direct work in GLP and cGMP environments, and experience with vaccine manufacture, injectables, controlled release, capsules, topical formulations, and aerosols.•Quality Control Expert- documentation, OOS investigations, CAPAs implementation, raw materials, in-process, finished product analysis, stability study designs and executions and report generation.•Academic level research in the identification of drug targets, simulation of ligand receptor complexation, creation of a predictive receptor-based 3D-pharmacophore model using MOE with integrated QSAR models and subsequent model validation. •Quality Control, cGMP, GCP, CMC-Analytical Control strategy, Chemical Hygiene, Biosafety and Laboratory management.
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