Solomon Hailu

Enthusiastic and driven analytical chemist with over a decade of practical laboratory experience in analysis of pharmaceutical samples. Proven expertise in method development, validation, and quality control testing (i.e. Assay, Stability, organic impurities etc...) using classical analytical methods (i.e. volumetric and gravimetric techniques) and advanced analytical techniques like UPLC, LC-MS, GC-MS, ICP-MS and others to support drug filings and regulatory compliance. My expertise extends to interpreting data, executing method transfers, and ensuring adherence to cGMP standards.  

Senior QC Analytical Chemist 

     Psygen Lab Inch. Calgary, AB 

     June 2024 to September 2025  

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) and established analytical procedures and techniques. 

Analytical method development and validation using principles of Quality by Design for drug substance and drug compounds. 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 for large scale manufacturing in Production Labs in GMP environment. 

Senior QC Chemist 

Trillium Health Care Products, Brockville, ON  

May 2022 to May 2024  

Method development (ID, Assay & Organic Impurities) and validation for drug substance and drug products using HPLC, UPLC and GC. Then write the protocol based on the results. 

Testing of in-process, bulk, finished product, stability samples and raw materials by TLC, UV, IR, HPLC and GC and wet chemistry techniques as per SOP, USP, EP, BP. 

Provide bench support for testing, method transfers, protocol executions, and associated analytical requirements (equipment sourcing and evaluation) related to project work. 

Act as contact for analytical customer representatives regarding project deliverables and initiatives. 

Creation/modification/management of the documentation pertaining to the new product introduction including change controls, verification/validation activities, method transfers, vendor certification, AWC creation/updates and CALS updates. 

Initiate and lead laboratory investigations, notification of events (deviation reports), and provide technical expertise on CAPA related to project work. 

Work with QC lab on continuous improvement opportunities to ensure the lab stays compliant and competitive with today’s industry standards. 

Carry out special projects, involved with new product launches or as assigned by lab leadership (technical/analytical bench support and documentation support required). 

Provide training support on instrumentation and procedural techniques for analysts to allow transfer of project work into the mainstream production environment. 

Analytical Chemist 

Toronto Research Chemicals/LGC Standards. Vaughan, ON 

October 2019 to April 2022  

Perform structural elucidation of synthesized intermediate and finished organic compounds using NMR and MS spectroscopy. 

Provide analytical support for finished and in process pharmaceutical chemicals using modern analytical techniques such as: Nuclear Magnetic Resonance (NMR), Mass Spectrometry (MS), Ion Chromatography (IC), Optical rotation (OR), Gas Chromatography (GC, GC-MS), High performance Liquid Chromatography (HPLC, ELSD, LCMS), Karl Fischer (KF), elemental analysis (CHN, ICP-MS). 

Responsible for calibration and use of laboratory instrumentation. 

Develop and validation of new HPLC and GC methods for new drug substance. 

Interpret and report analysis results in accordance with the guidelines of documentation and reporting. 

Independently organize work tasks for the day according to business priorities and backlog. 

Senior Analytical Chemist 

Chemical Industry, Addis Ababa, Ethiopia 

February 2010 to June 2013  

Perform the Physico-Chemical tests for pharmaceutical, environmental, food, water and wastewater samples using spectroscopic, chromatographic and wet chemistry techniques. 

Provided training on operational procedures, general maintenance, and theoretical background to 20+Analytical Chemists on analytical instruments. (i.e. LC-MS, GC-MS, HPTLC, NMR, UV, FT-IR, ICP-OES and AAS, HR-SEM, TGA and XRD) via presentations and hands-on-training, resulting in the chemists become more specialized in an instrument. 

Performed routine preventative maintenances, OQPVs, IQ, calibrations, and repairment of 20+analytical instruments, and communicated with service contractors and instrument suppliers regarding external operation qualifications and purchasing transactions for new instruments, instrumentation parts and consumables, allowing the instruments to be in optimal conditions and reducing instruments’ downtime status. 

Initiated, investigated, resolved, and written quality documents for laboratory instrument control and processes including IQ, OQPV (operation qualification and performance verification certification), SOPs, repair reports, and deviation report including investigation processes and instrument statuses, which led to successful external audits for ISO 9001 and 17025 regulations regarding analytical department processes. 

Analysed and solved quality problems regarding analytical processes such as performance of the analytical chemists, implementation of new instrumentation, and instrumentation operations and processes, and communicated to various department stakeholders with visual metrics, dashboards, and reports. 

Junior Chemical Laboratory Technician 

       Chemical Industry, Addis Ababa, Ethiopia 

       March 2009 to January 2010  

Conducting different laboratory analysis using classical and modern analytical techniques for pharmaceutical, food, textile, leather and environmental samples 

Administer the chemical and laboratory equipment warehouse 

Performed both general and preventative maintenance on machines, tools and laboratory equipment 

Assisted in clearing debris and hazardous materials from the laboratory 

Test samples of materials or products to ensure compliance with specifications, using test equipment 

Analytical Chemistry (Postdoctoral Research) 

Tshwane University of Technology, Pretoria, South Africa  

January 2017 to December 2017 

Analytical Chemistry (PhD Degree) 

Addis Ababa, University, Addis Ababa, Ethiopia 

October 2013 to August 2016 

Analytical Chemistry (PhD Research Work) 

Council of Scientific & Industrial Research (CSIR), Chennai, India 

February 2015 to December 2016 

Analytical Chemistry (MSc Degree) 

Addis Ababa University, Addis Abeba, Ethiopia 

September 2011 to August 2012 

Chemistry (BSc Degree) 

Addis Ababa University, Addis Ababa, Ethiopia 

September 2004 to June 2008 

HPLC Method Development (College certificate) 

Seneca College, Toronto, Canada 

May 2023 to August 2023