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

Company Profile:

The Centre for Probe Development and Commercialization (CPDC) is dedicated to fostering the development, translation, and commercialization of 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 and develop future drugs within the CPDC portfolio.

The ideal candidate has experience working in a Pharmaceutical Quality Control Laboratory, performing Biological Potency Assays (Elisa, IRF, etc), analysis of ADC (Antibody Drug Conjugates), and Chemical Potency and Impurities analysis (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

  • Quality control testing of materials and finished drug products (radiopharmaceuticals) including chemical, biological and microbiological tests using various analytical techniques such as HPLC, GC, TLC, pH, IRF, ELISA, Bacterial Endotoxin Testing, sterility testing, bioburden testing, etc. according to standard operating procedures.
  • Calibration/maintenance of lab equipment (refrigerators, freezers, incubators, HPLCs, GC's etc.)
  • Inventory/material management of QC materials (reagents, supplies) and maintenance of cell lines (eukaryotic cells)
  • Analytical method development, transfer, troubleshooting, and validation.
  • Investigate of out-of-specification or out-of-trend results and document 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 Chemistry , Biological Chemistry, Biotechnology, or a related discipline.
  • 5+ years' hands-on experience in a pharmaceutical GMP environment, working with small molecule testing methodologies (e.g. HPLC; TLC; GC), as well as with microbiological / biological testing assays including: Bioburden, Sterility, Bacterial Endotoxins, ELISA, Immunoreactivity Fraction Assay, and Protein/Peptide characterization.
  • 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.
  • Experience in aseptic operations (use of a BSC - Biological Safety Cabinet) and working with sterile pharmaceuticals are assets.
  • Hands on experience with analysis of radiopharmaceuticals (under Canadian Nuclear Safety Commission regulations ) 
  • 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

  • * 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