Job Description
Job DescriptionenGene (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.RoleenGene 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.
ESSENTIAL DUTIES AND 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.
EDUCATION AND EXPERIENCE
- 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.
SKILLS
- 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.
- Strong critical thinking, analytical and troubleshooting skills.
- Extensive experience with cGMP and guidelines (ICH, FDA, EMA, Health Canada).
- Experience working with nucleic acids and/or polymers preferred
Location: USA Boston Massachusetts Salary: The salary range for this role is $150,000-$165,000The base salary range provided represents a good faith estimate of the compensation for this position at the time of posting. Actual compensation will be determined based on a number of factors, including, but not limited to, relevant skills, experience and education.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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.