Scientist, Analytical Development

You will love this role if you have a passion for science and medicine, you thrive in a fast-paced environment and enjoy contributing to drug development in an integrated communicative team environment.

The Analytical Development Scientist will be responsible for the planning / development / implementation / optimization of assays necessary for assessing protein characteristics. The incumbent will participate in the assessment of the quality of manufactured lots using platform tests and support R&D activities. Additional responsibilities will be to plan and execute the pre-validation of developed assays using defined scientific and regulatory practices required for assay transfer to QC laboratories. An important part of the role will be to structure data analysis, perform the trending of data, and to write and / or review analytical documentation (analytical development reports, analytical methods, work instructions for the use of laboratory equipment, etc.). The incumbent will also organize and execute the development of appropriate formulations to ensure stability and suitability for clinical administration of a drug product.

This is a full-time position that reports to the Associate Director, Analytical Development and is based in Montreal.

Key responsibilites :

• Design the development or implementation of analytical assays for protein-based compounds.
• Lead the development of robust analytical procedures adapted to manufactured proteins assay panel.
• Use scientific knowledge and field established best practices in use for product analytical characterization.
• Provide scientific support and guidance during assay development and product characterization.
• Participate in the assay transfer, qualification or validation as per ICH guideline to QC laboratories.
• Perform structured data analysis, trending and basic statistics.
• Generate internal protocols, reports and procedures.

Qualifications :

Experienced in experimental planning, problem solving and troubleshooting.

Contact :

Please send your CV and cover letter outlining your motivation and relevant experience for the role to careers@35pharma.com quoting “35Pharma Posting SAD0605” in the subject line – we are looking forward to hearing from you!

35Pharma is a biopharmaceutical company focused on designing and developing innovative biologics for diseases with high unmet medical need.

750 St Laurent Boulevard, Suite 101

Montreal, QC H2Y 2Z4

Canada

50 Milk St.,

Boston, MA 02109

United States

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