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 researchers who will play a key role in the CMC 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, and ensuring compliance with regulatory requirements. The ideal candidate will have a strong background in analytical sciences, project management, and a proven track record of success in CMC activities.
You will bring your science to work in a dynamic, fast-paced, collaborative, and supportive environment, as well as perpetuate the company culture that promotes our values (Patient-focused, Integrity, Innovation and Teamwork).
(This is an onsite role based in our Boston office working 3 days onsite)
Essential Duties & Responsibilities
- Lead the planning and execution of analytical technology transfer activities from development to commercial manufacturing sites
- Collaborate with cross-functional teams within enGene and at our CMOs; including R&D, Quality Control, and Manufacturing, to ensure a seamless transfer of analytical methods
- Identify and mitigate potential risks during technology transfer processes
- Analytical Method Validation:
- Develop and implement strategies for analytical method validation in compliance with regulatory guidelines (e.g., FDA, EMA, Health Canada)
- Design and execute validation protocols, ensuring robustness, accuracy, and precision of analytical methods
- 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
Project Management:
- Manage timelines, resources, and budgets associated with analytical technology transfer and validation projects
- Provide regular updates to senior management on project progress, highlighting any potential issues or deviations
Skills
- Strong critical thinking, analytical and troubleshooting skills.
- Experience working with nanoparticles, nucleic acids and/or polymers is preferred.
- Intelligent, creative, proactive, organized and highly motivated team player.
- Proficiency in MS Office Suite and various statistical software (JMP, Prism, etc.).
- Excellent verbal and written communication in English (French represents an asset).
Education & Experience
- PhD, M.Sc or B.Sc in analytical chemistry, polymer science/biochemistry/biotechnology related with relevant Pharma/Biotech industry experience.
- Experience in development and GMP qualification of analytical methods to determine identity, purity, quality, and stability of products as part of in-process controls and batch release testing (especially for biologics) is an asset.
- Demonstrated experience of late-stage or commercial-stage validation for analytical methods (specificity, linearity, limits of detection and quantification, range, accuracy, precision, robustness, and stability).
- Experience in analytical method development, data analysis and interpretation, and validation/transfer is required
- Experience with a broad range of analytical instrumentation and techniques like HPLC, GPC (SEC), LC/MS, ICP-MS, NMR, UV-vis, fluorescence spectroscopy, DLS, Karl Fischer titration, and gel electrophoresis are great assets
- Experience with cGMP and guidelines (ICH, FDA, EMA,)
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.
