Role Summary
Senior Analytical Scientist at Stoke Therapeutics, joining the Analytical and Formulation Sciences team. The role focuses on UPLC method development and mass spectrometry-based characterization of oligonucleotides and their conjugates to support the development of oligonucleotide-based therapeutics. This position reports to the Director, CMC and is based in Bedford, MA with approximately 5% travel.
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
- Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 6+ years of relevant industry experience; or MS with 10+ years of experience; or Bachelor's with 16+ years of experience.
- 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 is desired.
- 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.
Additional Requirements
- Location: Bedford, MA (based in Bedford).
- Travel: approximately 5% travel.