Job Description
The Analytical Development Junior Scientist role is to organize the development of defined assays, necessary for assessing product characterization and product quality of manufactured lots. The incumbent will also participate to product assay specification and limits assessment definition for manufacturing batch release and stability studies. Other responsibilities are to use defined scientific practices in the development and/or use of analytical procedures, ensure assay transfer to QC laboratories, participate to the planning and performance of assay qualification and validation, contributes to stability study design and data trending. Write investigations on out of specification results. Participate to the development and overview of the characterization package for novel molecular entities. Upon request, act as a delegate person of the analytical team within cross-functional teams. The position is based out of Montréal, QC.
Duties and Responsibilities
- Design the development of analytical assays
- Participate to specification limit setting, necessary for cGMP release bulk drug substance and drug product for clinical trials
- Develop robust analytical procedures adapted to the evaluated compound
- Perform data trending and specification limit evaluation
- Prepare investigation reports on out of specifications
- Use scientific knowledge and field established practices in use for product analytical characterization and formulation development plans
- Provide scientific support and guidance during assay development and product characterization
- Participate to assay transfer, qualification and validation as per ICH guideline
- Generate any internal protocols and reports, including assay development reports, certificate of testing used for the release of manufactured lots and stability studies
- Contribute to the planning, data analysis and report generation of stability studies
- Participate to special projects related to analytical topics
- Use a quality by design (QbD) approach during all phases of analytical development
Qualifications
- Undergraduate level (B.Sc.) in pure or applied sciences or equivalent with at least 5 years of experience in analytical development or relevant experience in the pharmaceutical or biotechnology industry
- Experience in managing scientific projects
- 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
- Ability to work in cross-functional teams and in a fast-paced environment
- Experience in problem solving and trouble-shooting
- Excellent verbal and written communication skills
How to Apply
Please submit your CV and cover letter in PDF format to careers@forbius.com. Please indicate the position title in the subject line of your email. We will contact you should we wish to arrange a meeting to discuss this position further.