Shekhar Bhama, Ph.D. Email & Phone Number

Ontario, Canada

• Handling Analytical Method Validation on HPLC, GC-MS for Active Pharmaceutical Ingredients (API) for Antibiotic, Anti-cancer, Anti-depressent and various other Drug Substances as per compendia or in-house specification.• Increased 60% efficiency in Quality Control department by creating Instrument Methods on Empower 3 software for regularly tested drug substances and products reducing time for analyst and reviewers and errors for PR.• Performing Cleaning Validations as Equipment Cleaning Rinse Validations for drug substances used in reactors in the production area.• Instrumental in preparing Analytical Validation protocols and reports for regulatory submissions and audits as per the cGMP.• Proficient in using Trackwise software for Change Control, Deviations, LIR (Laboratory Investigation Report), Investigations and CAPA.• Expertise in System Suitability troubleshooting, and conducting LIR investigations for Out Of Specification (OOS) results.• Ensures compliance of High Quality, Data Integrity, cGMP, GDP, and lab safety practices in the laboratory and participates actively in the internal and external client, USFDA, Health Canada audits.

Baddi, Hp, India

• Performed various Analytical Method Development and Validation on HPLC, GC-FID for Antibiotic and Anti-cancer (Sterile) Drug Substances and Finished Products as per compendia or in-house specification.• Achieved target number of Stability Study protocols and reports for Drug Products at Long term, Intermediate and Accelerated conditions as per defined client zone following ICH guidelines.• Instrumental in Dissolution profile, Physical testing analysis, Karl Fischer (KF), Forced Degradation studies, system suitability troubleshooting, and reporting Out Of Specification (OOS) results.• Responsible to communicate and solving queries from Drug Regulatory Affairs (DRA) related to Chemistry, Manufacturing, and Control (CMC) for filing dossiers across 60 countries. • Analyzed and released more than 300% batches of Meropenem and Enoxaparin Sodium using AAS instrument and Super oxidized (HOCl) sanitizer to ROW countries during peak Covid-19 time.• Ensured compliance of High Quality, Data Integrity, cGMP, GLP, GDP, lab safety practices in the laboratory and participated actively in the internal and external client/WHO/MOH audits and certification.

Noida, India

• Designed and executed novel synthetic routes and chromatographic purification for new chemical entities (NCE) screened for Structure-Activity Relationship (SAR) studies for Anti-cancer drugs. • Instrumental in the synthesis and purification of more than 200 New Drug Molecules in 3 years with ≥ 95 % purity, each involving 6-9 steps.• Successfully conducted Chromatographic purification using Biotage Column Chromatography and analyzed by TLC, HPLC, GC-FID, MS, NMR, IR spectroscopy.• Increased final product shipment up to 1.8 times having coordinated with a team of 4 training associates.• Documented every reaction performed in the Laboratory Notebook and ensured completion of all given projects on time, purity assessment, and shipment.• Updated bi-weekly to Eli-Lilly Clients, USA, with status reports through teleconferencing.• Ranked in top 5% of employee performance for 2 years running showing excellence in problem solving, adaptability, and being reliable.

Noida, Uttar Pradesh, India

Noida, Uttar Pradesh, India

Doctor Of Philosophy - Phd, Analytical Chemistry

Activities and Societies: Taught classes: • (CHEM-207 and 208): Introduction to Analytical Chemistry I and II. • (CHEM-209): Introduction.

Industrial Pharmaceutical Technology Program, Quality Assurance And Gmp Compliance

Courses includes: 1. Pharmaceutical Quality Assurance Basics 2. A Practical approach to QA System Design/Management 3. Qualification.

Research Associate, Analytical Chemistry

• Explored the catalytic applications of 1-3 nm sized core@shell nanoparticles using Au, Cu, and Pd, in hydrogenation and isomerization.

Master Of Science (Honors), Chemistry

Research Thesis: Synthesis and Characterization of New-Complex Salts of tris (1, 10-phenanthroline) cobalt (III). • Synthesized various.

Bachelor Of Science (B.S.), (Industrial Chemistry)