Raj Rai
Montreal,Québec
Summary
Determined and well-rounded individual with more than 5 years of working experience as a Scientist/Research project lead within the pharmaceutical industry/Academia. Sharp and focused professional offering skills in pre-clinical study management. Communicative Scientist proficient in safety procedures, processes and regulations. Pursuing role and leveraging exceptional technical knowledge to better satisfy customer needs with dynamic knowledge in Analyst, Microsoft office, PMOD PET imaging, LIMS (Watson) software with Highly motivated with outstanding writing and interpersonal skills.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Scientist
Bioanalysis Charles River Labs Montreal
05.2022 - 06.2023
- Prepared and reviewed study-related documentation (draft study plans, amendments, technical procedures, etc.), in collaboration with the Study Director as per ICH/FDA regulations
- Assisted in the performance of QC review of Sample Login binders, Bioanalytical run binders, Wet Lab notebooks, data tables, data table summaries and electronic submissions before QA submission
- Reviewed toxicology study plans and amendments (sections pertaining to Bioanalytical), in collaboration with the Study Director/Principal Investigator and/or Individual Scientist;
- Analyzed the results wrote and reviewed technical reports and procedures;
- Interacted with sponsors, suppliers, quality assurance auditors, regulatory auditors and Study Directors, as required;
- Assisted in effectively scheduling the activities for validations and analysis of biological samples in a multi-disciplinary laboratory using a variety of extraction techniques, manual testing, automated equipment and analytical instruments
- Coordinated multiple projects and studies
- Utilized software such as Watson, Analyst, and MS Office
- Obtained various learning courses such as the Clinical Research Coordinator course offered by CITI program.
Quality Assurance Inspector (CRO)
ITR Labs
02.2022 - 05.2022
- Participated in the inspection of data, various documents, archives and study plans to confirm compliance with GLP and company standards
- Observed personnel in the laboratory to ensure they were following relevant procedures and working in compliance with GLP
- Helped in facilities inspection to ensure the facility is fit for purpose and complies with the regulations
- Participated in the review and development of technical and QC SOPs to ensure compliance with appropriate regulations
- Tracked and reported deviation trends to the scientific and management team.
Research Project Lead
University of Saskatchewan
11.2019 - 01.2022
- Utilized UPLC/MS to quantify more than 50 metabolites from urine to help prepare a clinically relevant model to distinguish between Asthma and COPD
- Kept the lab and all its members up to date with safety policies and training along with maintaining lab inventory
- Clinical sample data collection and storage in regards to accuracy and privacy
- Corrected operations of all the standard laboratory equipment including HPLC, Mass Spectrometer, and Biosafety cabinet, following appropriate training
- Analyzed clinical samples for assay verification and validation
- Collaborated with Stat Canada to manage clinical research
- Performed scientific assessment of various projects
- Synthesized chemical moieties to functionalize nanodiamonds and applied various techniques such as NMR, FTIR, MS, DLS zeta sizer, gravimetry and gel electrophoresis for characterization and formulation strategy
- Optimized a novel method for labelling hard nanoparticles with a radioactive isotope, Zr89 to Perform biodistribution followed by PET/CT scanning, image process by PMOD PET imaging software and pharmacokinetics studies in mice using a cyclotron facility
- Provided Brief lectures to undergraduate pharmacy students (3rd Year) on pharmaceutical Biotechnology techniques such as DNA extraction, Gel Electrophoresis, Western blot, cell culture, and SDS PAGE.
Project Engineer
Wipro Technologies
05.2013 - 08.2015
- Assisted in the development of detailed design documents, Sequence Diagrams, and Use-case definitions
- Worked on SQL/PLSQL databases
- Developed the unit test cases and demonstrated the application as a part of the Release
- Assisted in the 'Automated Teller Machine' enhancements during the Maintenance Phase
Education
MSc - Pharmaceutical Sciences Saskatoon, Saskatchewan
University of Saskatchewan, College of Pharmacy and Nutrition
Postgraduate Diploma - Management
Okanagan College
Kelowna, BritishSkills
- LCMS Bioanalysis
- GLP Compliance and regulation
- Biodistribution
- Quality Assurance
- Radiochemistry/Amide Chemistry
- Western Blot, Cell Culture
- Sales Marketing
- SQL/PL/SQ
- CRO experience ICH/ US FDA Regulations
- Results Analysis
- Assay Development
- Project Management
- Research and Publication
- Lab Experiments and Research
- Safety Processes
- Critical Thinking
- Clinical Studies
- Microsoft Dynamics
- Scientific Principles Application
- Quality Production
- Experiment Protocol Development
- Laboratory Equipment Functions
Additional Information
- Clinical Research Coordinator course, CITI program, August 2023, Canada. 990 Research Seminar Award 2019, University of Saskatchewan, Canada. Awarded the first Dr. Ed Knaus Graduate Scholarship in Pharmaceutical Research, University of Saskatchewan, Canada Held Interdisciplinary Graduate Scholarship, University of Saskatchewan, Canada Successfully achieved Dean’s List of Business Administration Post Baccalaureate Diploma in Marketing, Okanagan College
Certification
● Good Manufacturing Practices, Sylvia Fedoruk Center for Nuclear Innovation, Canada
● UACC Anesthesia workshop, University of Saskatchewan, Canada
● UACC Rodent handling workshop, University of Saskatchewan, Canada
● UACC Animal Ethics Course: Basics, University of Saskatchewan, Canada
● Radiation Safety Training, University of Saskatchewan, Canada
● Biosafety Training, University of Saskatchewan, Canada
● Health and Safely Training, University of Saskatchewan, Canada
● Lab safety training, University of Saskatchewan, Canada
● Nuclear Magnetic Resonance training, University of Saskatchewan, Canada
Pulications
· Biodistribution of nanodiamonds is determined by surface functionalization. Diamond and
· Chitosan Nanoparticles at the Biological Interface: Implications for Drug Delivery. Pharmaceutics 2021, 13, 1686. https://doi.org/10.3390/pharmaceutics13101686
· Polymeric nanoparticles in gene therapy: new avenues of design and optimization for delivery applications. Polymers 2019, 11, 745; doi:10.3390/polym11040745.
· Anti-Microbial activity of TiO2 microparticles in suspension on E. coli strains under UV irradiation. IOSR Journal of Pharmacy and Biological Sciences (IOSRJPBS) ISSN: 2278-3008 Volume 1, Issue 1 pp 21-30.
Timeline
Scientist
Bioanalysis Charles River Labs Montreal
05.2022 - 06.2023
Quality Assurance Inspector (CRO)
ITR Labs
02.2022 - 05.2022
Research Project Lead
University of Saskatchewan
11.2019 - 01.2022
Project Engineer
Wipro Technologies
05.2013 - 08.2015
MSc - Pharmaceutical Sciences Saskatoon, Saskatchewan
University of Saskatchewan, College of Pharmacy and Nutrition
Postgraduate Diploma - Management
Okanagan College
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