Kelly Services Bioanalytical Chemist in Hamilton, Canada
Kelly Scientific Resources (KSR) is a specialty service of Kelly Services, Inc., a leader in providing workforce solutions. Since its launch in 1995, KSR has provided staffing and placement services to a broad spectrum of industries, including biotechnology, chemical, consumer products, cosmetics, environmental, food sciences, medical/clinical, pharmaceutical, and petrochemical. Today, KSR leads the world in dedicated scientific and clinical research staffing. Visit www.kellyscientific.com to learn more and view a full listing of our opportunities.
Development, validation and method transfer of analytical and bioanalytical test methods. You will also be involved in the implementation of these methods to support GMP release of raw materials, in-process materials and finished products.
Analytical method development, transfer, troubleshooting, and validation.
Write, revise and review technical documents including SOPs, test methods, validation protocols and reports.
QC testing of materials and finished drug products. This may include chemical, biological and microbiological tests using various analytical techniques (HPLC, GC, TLC, pH, IRF, ELISA, Bacterial Endotoxin Testing, sterility testing, and bioburden testing according to standard operating procedures.)
Calibration and maintenance of lab equipment including refrigerators, freezers, incubators, HPLCs, GCs.
Investigate of out-of-specification or out-of-trend results and document non-conformances.
MSc or PhD in Chemistry, Biological Chemistry or Biotechnology.
3+ years’ experience in a Pharmaceutical QC Lab, performing Elisa/ IRF, Chemical Potency and Impurities Analysis (SE-HPLC, TLC, GC) & analyses of Antibody Drug Conjugates.
Knowledge and hands-on experience working with biological techniques such as Immunoreactive Fraction, Bioburden, Sterility, ELISA, Peptide/Protein classification & working in GMP setting with HPLC & GC.
A working understanding of appropriate regulatory guidance for validation and international pharmacopeias (ICH, USP, Ph.Eur.).
Proficiency with spreadsheets and ability to write technical documents and reports.
Good communication skill and ability to work both independently and in a team.
This position may require shift work (scheduled day, night, or weekend shifts).
Ability to lift and move heavy weights up to 23 kilograms is required.