enGene · 6 days ago
Senior Scientist, Analytical Development
Boston, MA
Full-time
Onsite
Senior Level, Lead/Staff
$150K/yr - $165K/yr
8+ years expenGene is a late-stage biotechnology company focused on genetic medicines. The Senior Scientist will be responsible for overseeing analytical aspects of technology transfer, method validation, and ensuring compliance with regulatory requirements in the development of new gene therapy technology.
BiotechnologyDiabetesGeneticsHealth Care
Responsibilities
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
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
Qualification
Required
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
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)
Preferred
Experience working with nucleic acids and/or polymers preferred
Company
enGene
enGene is a biotechnology company develops treatment for mucosal diseases through inducing therapeutic proteins of harmful proteins.
11-50 employees
H1B Sponsorship
enGene has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
Funding
Current Stage
Public CompanyTotal Funding
$391.75MKey Investors
Hercules CapitalCystic Fibrosis FoundationForbion Capital Partners
2025-11-13Post Ipo Equity· $92.81M
2024-10-25Post Ipo Equity· $43.19M
2024-02-14Post Ipo Equity· $200M
Leadership Team
Ron Cooper
Chief Executive Officer | Member, Board of Directors
Joan Connolly
Chief Technology Officer
Recent News
2025-12-24
Company data provided by crunchbase