Centre for Probe Development and Commercialization
  • Hamilton, ON, CAN
  • Full Time

Biologist/Biotechnologist

Company Profile:

The Centre for Probe Developmenand Commercialization (CPDC) is dedicated to fosterinthdevelopment, translationand commercializatioof radio-labeled molecular imaging probes and therapeutic drug products.

Situated on the McMaster University Main Campus in Hamilton, CPDC is a growing organization and is looking for enthusiastic scientists to support current products andevelop future drugwithin the CPDC portfolio.

The ideal candidate has extensive hands-on experience performing Biological Potency Assays including Immunoreactive Fraction (IRF) - bead-based and cell-based assays, and ELISA testing (direct, competitive, etc.) for analysis of antibodies and ADC (Antibody Drug Conjugates).  In addition, having experience working in a Pharmaceutical Quality Control Laboratory for analysis of Chemical Potency and Impurities content (SE-HPLC, TLC, GC, etc.).

This individual will be responsible for the development, validation and method transfer of analytical and bioanalytical test methods, as well as implementation of these test methods to support GMP release of raw materials, in-process materials and finished drug products (radiopharmaceuticals).   

Duties / Responsibilities

  • Subject Matter Expert (SME) for IRF, ELISA, other bioassays, intact protein analysis, quantitation and identification.
  • Perform method development and quality control testing of materials and finished drug products (radiopharmaceuticals) including chemical, biological and microbiological tests using various analytical techniques such as IRF, ELISA, Bacterial Endotoxin Testing, HPLC, GC, TLC, pH,  sterility testing, bioburden testing, etc. according to standard operating procedures.
  • Calibration/maintenance of lab equipment (refrigerators, freezers, incubators, Gamma Counters, Scintillation Counters, HPLCs, etc.)
  • Inventory/material management of QC materials (reagents, supplies) and maintenance of cell lines (eukaryotic cells)
  • Analytical method development, transfer, troubleshooting, and validation.
  • Investigation of out-of-specification or out-of-trend results and documentation of non-conformances.
  • Write, revise and review technical documents, including Standard Operating Procedures, Test Methods, , validation protocols and reports.

Required Education/Experience/Knowledge:

  • M.Sc. or Ph.D in Biology, Biological Chemistry, or Biotechnology.
  • 5+ years' hands-on experience in a pharmaceutical GMP environment, working with large molecule and small molecule testing methodologies, particularly biological testing assays including ELISA, Immunoreactivity Fraction Assay, and Protein/Peptide characterization. 
  • Must have experience in aseptic operations (use of a BSC - Biological Safety Cabinet);  working with sterile pharmaceuticals are assets.
  • Experience in HPLC analysis is an asset.
  • Having a working understanding of appropriate regulatory guidance for validation and international pharmacopeias (ICH, USP, Ph.Eur.).
  • Proficiency with spreadsheets (e.g. Excel, Google Sheets), and ability to write technical documents and reports.
  • Good communication skills (in English) and ability to work both independently and cooperatively in a team environment.
  • Hands on experience with analysis of radiopharmaceuticals (under Canadian Nuclear Safety Commission regulations ) is an asset.
  • This position requires shift work (scheduled day, night, or weekend shifts).
  • Ability to lift and move heavy weights up to 23 kilograms is required 

If you require accommodation for your application or interview, please contact Human Resources directly at 905.525.9140 ext. 21112 or by email at careers@imagingprobes.ca

 

We thank all those who apply but only candidates selected for interviews will be contacted.

 

 

 

Centre for Probe Development and Commercialization
  • Apply Now

    with our quick 3 minute Application!

  • * Fields Are Required

    What is your full name?

    How can we contact you?

    I agree to PrevueAPS's Applicant Information Use Policy.*
  • Sign Up For Job Alerts!

  • Share This Page
.
Logo Home About Products Pipeline Services R and D Partners Careers Contact