Senior Analytical Scientist
Stoke Therapeutics
Full-time
Remote friendly (Bedford, MA)
United States
Operations
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Role Summary
We are seeking a highly skilled and motivated Senior Analytical Scientist to join our Analytical and Formulation Sciences team. The ideal candidate will have strong hands-on experience in UPLC method development, and mass spectrometry-based characterization of oligonucleotide and conjugates. This role is critical to supporting the development of innovative oligonucleotide-based therapeutics. This position will report into the Director, CMC. Based in Bedford, MA.
Responsibilities
- Develop, optimize, and validate UPLC methods for the analysis of oligonucleotides and their conjugates.
- Conduct mass spectrometry (LC-MS, HRMS, MS/MS) analyses to characterize oligonucleotide and its conjugates.
- Interpret analytical data to support product development, stability studies, and release testing.
- Collaborate with cross-functional teams including Process Development, Quality, and Regulatory Affairs.
- Author technical reports, method development summaries, and regulatory submissions (e.g., IND, BLA).
- Perform routine formulation preparation and characterization of oligonucleotide drug products for preclinical studies.
Qualifications
- Proven experience in UPLC method development for oligonucleotides or nucleic acid-based therapeutics.
- Strong expertise with mass spectrometry for structural and quantitative analysis of oligonucleotide and conjugates.
- Strong data analysis skills and proficiency with analytical software (e.g., Empower, MassLynx, Xcalibur).
- Excellent communication, documentation, and organizational skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Knowledge of ICH guidelines and regulatory expectations for analytical method validation.
Education
- Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 6+ years of relevant industry experience; or M.S. with 10+ years of experience; or Bachelor's with 16+ years of experience.
Additional Requirements
- Travel: Approximately 5% travel.