• Developed challenging analytical methods for semi-solid products• Review documents in full compliance with company and regulatory requirements

• Supervise projects• Work on method optimization, remediation, compendial method and method transfer for global division • Design risk based approach and experimental technique• Assist to solve critical method deficiency, deviation and technical issues• Review and evaluate technical documents, test methods, protocols and reports• Plan, design, implement and analyse to aid in the development of new products or improvement of existing products.• Prepare laboratory for TPD… Show more • Supervise projects• Work on method optimization, remediation, compendial method and method transfer for global division • Design risk based approach and experimental technique• Assist to solve critical method deficiency, deviation and technical issues• Review and evaluate technical documents, test methods, protocols and reports• Plan, design, implement and analyse to aid in the development of new products or improvement of existing products.• Prepare laboratory for TPD and FDA Audits Show less

• Supervised projects and a group acted as a team leader for specific projects with up to 3 chemists• Evaluated API sources and reviewed alternate API supplier’s (Drug Master File) DMF• Identified potential impurities and residual solvents in API from a specific process. Developed analytical methods, validated and prepared reports for drug product and drug substance. Generated drug substance specification• Worked on method optimization, remediation, compendial method and method… Show more • Supervised projects and a group acted as a team leader for specific projects with up to 3 chemists• Evaluated API sources and reviewed alternate API supplier’s (Drug Master File) DMF• Identified potential impurities and residual solvents in API from a specific process. Developed analytical methods, validated and prepared reports for drug product and drug substance. Generated drug substance specification• Worked on method optimization, remediation, compendial method and method transfer. Investigated unknown impurity OOS/OOT results using PDA and LC-MS • Prepared laboratory for Health Canada and FDA Audits• Trained chemists on HPLC and GC techniquesAccomplishments: • Achieved ‘First time right’ objectives consistently• Qualified new source of API and saved money Show less

• Developed and validated analytical methods as per protocols and generated validation report (TLC, UV, residual solvents, assay and impurity methods) for Liquid and semi-solid dosage forms• Provided technical leadership and guidance in scientific matters• Performed stress study and evaluated mass balance and generated reports• Screened API and provided data support for selection of API • Conducted tests for certificate of analysis (C of A) (e.g. Description, IR, UV, specific… Show more • Developed and validated analytical methods as per protocols and generated validation report (TLC, UV, residual solvents, assay and impurity methods) for Liquid and semi-solid dosage forms• Provided technical leadership and guidance in scientific matters• Performed stress study and evaluated mass balance and generated reports• Screened API and provided data support for selection of API • Conducted tests for certificate of analysis (C of A) (e.g. Description, IR, UV, specific optical rotation, assay, impurities, related compounds, degradation products, organic volatile impurities, water content, LOD, residue on ignition, melting point, heavy metals and particle size)• Investigated LIR, DR, unexpected issues in development stages and daily laboratory work• Responded to complex questions and provided technical support within and outside the departmentAccomplishments: • Assisted successful ANDA submissions filing • Resolved numerous technical issues in a timely manner Show less

• Identified molecular chirality using unique NMR technique• Synthesized and characterized new compounds using UV, IR, NMR and X-Ray