Overview:
The Product Development and Quality Team is looking for a focused and motivated individual interested in making significant contributions in the area of analytical chemistry to support the development, translation, and commercialization of molecular imaging probes. Interested applicants must be capable of working independently in a fast-paced and highly regulated environment.
Responsibilities and job tasks include, but are not limited to, the following:
- Conduct all work in accordance with appropriate regulatory guidance, international pharmacopeias, ICH, GxPs, established business processes and protocols, and applicable standard operating procedures
- Independently carry out analytical methods development, chemical characterization studies and chemical stability characterization evaluations
- Perform method validation activities for analysis of radiopharmaceuticals and radiochemical metabolites
- Provide analytical support for process development including characterization of starting materials, intermediates, API and finished products
- Work with Quality Assurance, Regulatory Affairs and Process Development to define specifications for raw materials, intermediates and finished products
- Lead the qualification/transfer of analytical methodology from external sources to quality control laboratories
- Prepare working plans for new projects and provide updated timelines to the project team
- Report analytical results and conclusions in the form of weekly presentations and/or reports to customers and/or project teams
- Write formal reports for inclusion in regulatory filings and supporting the generation of appropriate responses to questions from regulatory authorities.
- Providing scientific guidance, leadership and training to others within the department and between departments
- Maintain a laboratory notebook in compliance with recognized good documentation practices and relevant GxPs
- Write technical documents, including SOPs, validation documents and reports
- Review technical documents and data, including SOPs, validation documents and reports
Required Experience:
- Recognized post secondary education in analytical chemistry, organic chemistry, physical chemistry, or a related discipline
- M.Sc. with 5 years or PhD with 2 years experience in an R&D environment with a demonstrated record of scientific accomplishment, laboratory experimentation, publication and presentation
- Comprehensive knowledge of chemistry with extensive expertise in measurement science
- Laboratory experience with an in-depth knowledge of conventional laboratory characterization techniques such as HPLC, GC, UV, IR, mass spectrometry, and NMR is a must
- Working knowledge of GLP/GMP and applicable FDA, EMA and ICH guidances
- Expertise in the development of analytical methods for impurity and metabolite analysis
- Strong understanding of drug development with strong problem-solving and troubleshooting skills
- Strong capabilities in experimental design and execution
- Proven ability to work independently with strong communication skills, including proficiency in the English language, both written and oral
- Strong interpersonal skills and the ability and interest to serve as a team member/leader in an environment where individual initiative, collaboration and accountability are valued
To apply please submit a cover letter and a resume to careers@imagingprobes.ca.
Attention: Dr. Joe McCann.
We thank all applicants for their interest, but only those selected for interview will be contacted.
