Senior Scientist, Analytical Development

enGene • Boston, MA

1d • $150,000 - $165,000

About The Position

enGene (NASDAQ: ENGN) is a late-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, whose lead product candidate, detalimogene voraplasmid, is being evaluated in an ongoing pivotal study for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who are unresponsive to BCG. Detalimogene voraplasmid was developed using enGene’s PROPRIETARY, Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. For more information, visit enGene.com . Role enGene Inc. is seeking curious, passionate, and motivated Senior Scientist who will play a key role in the analytical group. In collaboration with others in the team, you will be an integral part of developing an exciting new gene therapy technology. You will be responsible for overseeing the analytical aspects of technology transfer, method validation, regulatory filing and ensuring compliance with regulatory requirements.

Requirements

• Advanced Degree: M.Sc . (or Ph.D.) in Analytical Chemistry, Polymer Science, Biochemistry, or a related discipline, with a minimum of 8 years of relevant experience in late-phase development (e.g., PPQ, commercialization) within Pharma/Biotech industry; or B.Sc . in the same fields with at least 10 years of relevant experience.
• Analytical Method Validation Expertise: Strong understanding of validation principles, including specificity, linearity, limits of detection and quantification, range, accuracy, precision, robustness, and stability.
• Regulatory Documentation Experience: Proven track record in preparing documents for regulatory submissions (FDA, health Canada, EMA) such as IND, IMPD and BLA.
• Strong critical thinking, analytical and troubleshooting skills.
• Extensive experience with cGMP and guidelines (ICH, FDA, EMA, Health Canada).

Nice To Haves

• Experience with analytical methods like HPLC, GPC (SEC), LC/MS, FTIR, UV-vis, fluorescence spectroscopy, DLS, Karl Fischer titration, and gel electrophoresis (CE, AGE) are great assets.
• Experience working with nucleic acids and/or polymers preferred

Responsibilities

• Analytical Transfer, Validation and lifecycle management: Collaborate with cross-functional teams within enGene and at our CMOs; including R&D, Quality Control, Quality Assurance, Regulatory affairs, Manufacturing, to ensure robustness of analytical methods used and high quality of the product delivered to the patients.
• Identify and mitigate potential risks during technology transfer processes.
• Develop and implement strategies for analytical method validation in compliance with regulatory guidelines (e.g., FDA, EMA).
• Coordinate and liaise with external vendors and partners involved in the validation process.
• Regulatory Compliance: Stay abreast of relevant regulatory requirements and guidelines pertaining to analytical methods and technology transfer.
• Ensure that all activities adhere to cGMP, ICH, and other relevant regulatory standards.
• Prepare and review documentation for regulatory submissions related to analytical methods and validation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level