Company: enGene Inc.
Position: Senior Research Associate/Scientist Analytical Development
Location: Montreal, Quebec
enGene Inc. is a high growth biotechnology company developing a robust, proprietary non-viral vector platform to deliver genes to various epithelial tissues. The vector system can be administered to the intestine via the oral or enema route, or the bladder via installation. enGene is developing its unique gut optimized gene delivery formulation into an orally available “Gene Pill™”, which has the potential to be a platform for oral delivery of a wide range of therapeutic protein drugs. The Company’s primary focus is to apply its technology to enable localized delivery of therapeutic proteins to the gut and other epithelial tissues for treating various disorders.
enGene Inc. is currently seeking a qualified and motivated candidate who will play a key role in the CMC group. In collaboration with project leaders, the Senior Research Associate/Scientist of Analytical Development will provide expertise to a team responsible for developing, optimizing, qualifying and performing assays, to support the pipeline development and production of nanoparticle gene therapy drug products and be an integral part of the Chemistry, Manufacturing and Controls (CMC) and Formulations teams. This position reports to the Manager Analytical Development and Quality Control.
The candidate will work in a dynamic, fast-paced and highly collaborative environment, as well as perpetuate the company culture that promotes our values (Patient-focused, Integrity, Innovation and Teamwork).
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Develop, perform optimize and qualify analytical methods for in-process, release and stability testing of drug products, drug substances, polymers and intermediates.
• Contribute to the assessment of process and product related impurities, to the development and qualification of the analytical methods for their quantification.
• Design and perform forced degradation studies for the identification of degradation impurities and pathways.
• Contribute to the development of stability indicating methods.
• Review method qualification protocols and reports.
• Author and review work instructions and reports.
• Contribute to preparation of regulatory documents (IND, CTA).
• Maintain good laboratory records using electronic laboratory notebook.
EXPERIENCE AND QUALIFICATION
• Ph.D. in analytical chemistry, polymer science/biochemistry/related with a minimum of 1 year related industrial experience or M.Sc. in analytical chemistry, polymer science/biochemistry/related with a minimum of 5 years relevant industrial experience.
• Experience in development and qualification of analytical methods to determine identity, purity, quality, strength and stability of products as part of in-process controls and batch release testing of gene therapy products.
• Understanding and experience regarding the validation principles of analytical methods (specificity, linearity, limits of detection and quantification, range, accuracy, precision, robustness and stability .
• Hands-on experience with a variety of methods: HPLC, SEC-MALS, NMR, LC/MS, GC/MS, FTIR, UV-vis, fluorescence spectroscopy, DLS, Karl Fischer titration, gel electrophoresis and others.
• Experience with cGMP and guidelines (ICH, USP, FDA, Health Canada)
• Experience working with nucleic acids and polymers preferred.
• Ability to define problems, design and execute experimental plans, analyze data, establish facts, and draw valid conclusions.
• Critical strong thinking, analytical and troubleshooting skills.
• Creative, proactive, detailed-oriented, organized and highly motivated team player.
• Proficiency in MS Office Suite.
• Excellent verbal and written communication in English (French represents an asset).
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