Senior Scientist, Sterile Oligonucleotide Drug Product Development
Stoke Therapeutics · Bedford, MA
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Role summary
Stoke Therapeutics seeks a Senior Scientist to develop sterile oligonucleotide drug products and manufacturing processes. The role involves formulation design, characterization, process optimization, and collaboration with contract manufacturers to support the company's antisense oligonucleotide pipeline.
What they're looking for
- PhD in pharmaceutical sciences, chemistry, chemical/bioengineering, or related field plus 4+ years industry experience
- Hands-on expertise with physicochemical and biophysical characterization methods (DSC, HPLC, LC-MS, particle sizing, etc.)
- Demonstrated experience in oligonucleotide drug product process development via publications, patents, or industry work
- Knowledge of FDA, EMA, ICH regulatory requirements and technical documentation standards
- Proficiency with risk assessment methodologies (FMEA, FMECA) and analytical software (JMP, Veeva, Prism)
- Strong scientific foundation in experimental design, data analysis, and problem-solving
What you'll be doing
- Develop oligonucleotide formulations in-house, conduct testing, and apply Design of Experiments for process scale-up
- Perform physicochemical and biophysical characterization using multiple analytical techniques and methods
- Author technical reports, methods, and regulatory filings aligned with FDA and international requirements
- Support manufacturing equipment selection and oversee scale-up from prototype to full-scale production
- Identify, assess, and mitigate manufacturing risks using established quality and risk management tools
Privacy & handoff
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