Solomon Hailu

Senior Qc Chemist @Psygen

Calgary, AB, CA

Perform sampling and analysis of laboratory samples including raw materials, in-process samples, finished products, cleaning validation samples, and stability samples using analytical instruments (i.e. UPLC, LC-MS.etc.) and established analytical procedures and techniques.• Analytical method development and validation using principles of Quality by Design for Psychedelic drug compounds such as DMT, LSD, MDMA, Pyilocybin, 5-MeO-DMT and Ibogaine. Prepare and execute analytical method validation protocols for all applicable product lines. Assist with the preparation of drug master files and Client CTA/IND filings.• Perform method transfer and verification of compendial methods, methods sourced from monographs.• Perform calibration, installation, qualification, maintenance of laboratory equipment as required by the department’s established calibration program and GMP requirements and contact with suppliers and vendors, and quote comparison.• Examine and establish specifications for new drug substances and drug products, as well as for in-process intermediates.• Recognize out-of-specification or out-of-trend results and, under the direction of management, assist in the completion of required investigations.• Document and compile observations and data obtained from testing as per established SOPs and good documentation practices. • Coordinate with Quality Assurance, Production, Marketing, and Sales for batch releases, OOS and OOT Investigations, Stability Data, Impurity Profiles of APIs and Intermediates etc.• Coordinate with external labs for release testing of finished APIs.• Maintain lab cleanliness, safety, and cGMP guidelines, and records for audit purposes.• Handle waste generated by analytical processes according to internal waste management standard operating procedures.• Plan, schedule, and prioritize laboratory activities to comply with timelines and meet deadlines.• Participated for Scale up Psychedelic API production in GMP environment.

CSIR-Central Leather Research Institute, Chennai, India

PhD Research Fellowship

Seneca College

Certificate

Tshwane University of Technology, South Africa, Pretoria

Postdoctoral in Analytical Chemistry

Addis Ababa University

Master's degree

Addis Ababa University

Doctor of Philosophy - PhD

Addis Ababa University

Bachelor of Applied Science (B.A.Sc.)