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Analytical Scientist

Ontario, ON
Analytical Scientist
 
PharmEng Technology is currently seeking an Analytical Scientist for a project in Ontario, Canada.  The position is available immediately conditional of a successful interview
 
Job Description:
  • Co-ordinate, manage validation, and assess test methods used for licensed vaccine products to ensure the validated status of the test method is maintained throughout test method life cycle, all while ensuring objectives and timelines are met.
  • Monitor test performance through trending and monitoring of test parameters and conduct scientific investigations into causes of atypical/aberrant test results.
  • Lead and manage test method changes, analytical transfers and enable implementation of new technologies within Quality Control.
  • Experience in analytical sciences for biologicals in a GMP manufacturing environment
  • Knowledge of the Good Manufacturing Practices in a regulated environment (pharmaceutical)
  • Experience in biological products characterization and release assays development
  • Knowledge of analytical assay transfer and validation as per ICH guidelines
  • Analytical Chemists perform controlled experiments to explore the exact chemical components of a substance.
  • Analyze various samples to discover what it is made of and how it reacts under certain conditions.
  • Utilizing various pieces of specialized equipment and advanced software, data is collected and analyzed to determine possible uses for the substance.
  • Write up complex technical reports detailing their findings. In addition, Analytical Chemists may be required to work on research teams and collaborate with other experts to achieve their end goal.
  • Plan and execute complex analytical and physical chemistry testing following the laboratory SOPs
  • Manage timelines by using testing expertise, advanced chemical knowledge, statistical tools, logic and creativity to overcome challenges. Be prepared to present results to various stakeholders
  • Identify potential challenges and proactively plan for resolution
  • Build relationships across multiple cultures and regions to support advancement in the field
  • Ensure that all reagents and solutions are prepared according to SOPs
  • Ensure that equipment is calibrated to confirm accuracy, reliability and precision.
  • Interpret and document all test results including calculations and observations in lab documentation.
  • Review peers' analytical data for accuracy and integrity.
  • Alert the Chemist-in-charge of unusual test results and of any difficulties or problems encountered during the performance of duties
 
Job Requirement:
  • Minimum Bachelor’s degree in Chemistry, Microbiology, Physics, Biochemistry, Cell Biology or a related field
  • Minimum 3 years’ experience in a Pharmaceutical industry with relevant experience in a Quality Control or R&D setting
  • Sound knowledge and experience in the fields of Quality Control testing, test method validation and Biological testing is essential.
  • Analytical scientist who can take on a specific method qualification/validation projects
  • Understanding of PKA
  • Previous supervisory experience is an asset
  • Experience in analytical sciences for biologicals in a GMP manufacturing environment
  • Knowledge of the Good Manufacturing Practices in a regulated environment (pharmaceutical)
  • Experience in biological products characterization and release assays development
  • Knowledge of analytical assay transfer and validation as per ICH guidelines is an asset
  • Strong organizational, communication and problem-solving skills.
  • Excellent project management skills
  • Ability to work in cross-functional teams and in a fast-paced environment
  • Experience in problem solving and troubleshooting
  • Excellent verbal and written communication skills
 
 
 
 
Thank you for your consideration and application!  We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.
 
 
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