Scientist- CMC Bioassay Development

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 The Scientist will play a hands-on role in laboratory activities supporting the bioassay function for enGene’s innovative gene therapy products. This individual will be responsible for establishing internal capabilities for bioassay development, testing, and extended characterization to support the advancement of enGene’s pipeline. Additional responsibilities include preparation and review of analytical CMC documentation, contribution to regulatory strategy, and authoring or reviewing analytical sections of regulatory submissions. This is a unique opportunity to make a meaningful impact in a dynamic environment where self-driven and enthusiastic individuals thrive. Essential Duties And Responsibilities Perform hands-on laboratory work to support biological assay development, transfer, and validation for release/stability testing, in-process controls, extended characterization, and testing of starting materials and intermediates. Execute and support development studies for process and product characterization, as well as comparability assessments. Assist in laboratory investigations, including OOS (Out-of-Specification) events, data trending, and contributions to manufacturing investigations in a compliant manner. Demonstrate strong technical expertise in cell-based potency assays; proficiency in data analysis tools and software (e.g., JMP, Prism, PLA) is highly desirable. Draft, review, and approve SOPs, protocols, specifications, forms, and reports for internal and external QC lab transfers. Assist in the preparation of CMC regulatory submissions, including data summaries and trend analyses. Ensure compliance with internal and external regulatory requirements (ICH, FDA, EMA, etc.) and GMP standards to support analytical policy and process development. Travel up to 25%, including occasional international travel to partner or contractor facilities. Skills Expert-level hands-on experience in biological assays, with a strong emphasis on cell-based potency assays. Ability to manage multiple tasks and projects effectively in a fast-paced, dynamic environment. Proven ability to proactively evaluate and independently solve complex problems. Strong oral and written communication skills, with the ability to clearly present experimental results and recommendations. Excellent interpersonal skills; able to work collaboratively across functions and manage diverse personalities. Self-motivated, independent, and results-oriented with a strong sense of ownership. Deep commitment to quality and team success. Strong analytical and organizational skills; detail-oriented with the ability to think strategically. Contribute to a professional, respectful, and collaborative work environment. Required Experience And Qualifications Bachelor’s degree or above in Biological Sciences or a related field, with a minimum of 5 years of hands-on experience in the biotechnology or pharmaceutical industry, focused on biological assay development for gene therapy. Knowledge and experience in biological method development, qualification/validation, and application for product development, and characterization. Proficiency in analytical techniques such as cell-based assays, ddPCR, enzymatic assays, flow cytometry, and ELISA. Excellent oral and written communication skills. enGene USA Inc. is an Equal Opportunity Employer: All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. At enGene USA Inc., we are building a community of intelligent and passionate team members that share our Vision, Mission, and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability. #J-18808-Ljbffr