Stoke is seeking an enthusiastic, collaborative and experienced Scientist to join the Bioanalytical, DMPK and Biomarker Development group. This is a lab-based role, and the successful candidate will be responsible for:
- Antigen conjugation with carrier proteins, purification and characterization of conjugates.
- Manage outsourced generation of anti-drug antibodies for use in PK (pharmacokinetics), ADA (anti-drug antibody), and nAb (neutralizing antibody) assays as needed.
- Develop ADA methods and work with CROs to transfer, qualify/validate bioanalytical assays, and support assay implementation.
- Review study protocols, manage critical reagent lots, and monitor GLP sample testing.
- Develop high-quality assays to quantitate oligonucleotides in biological matrices to understand the PK, absorption, metabolism, distribution, and excretion (ADME) of drug candidates.
- Partner with and support Toxicology.
- Present results at cross-functional team and lab meetings.
- Maintain accurate documentation of experiments in ELN.
- Prepare clear and accurate reports of internal and external projects as required.
- Help maintain the bioanalytical lab and keep the instruments running properly.
Essential Skills & Experience:
- Bachelor’s degree with 10+ years of experience, or Master’s degree with 8+ years of post-graduate experience, or Ph.D.
- Understanding of ADA and nAb assay, outlier identification, and cut point determination.
- Experience in the development of immunoassays (ELISA/MSD).
- Experience with transferring methods to CROs and managing activities for sample testing.
- Strong knowledge of ADME concepts and bioanalytical principles is desired.
- Good understanding of bioanalytical assay development, validation and implementation.
- Excellent problem-solving skills and ability to work as a team player in a dynamic environment.
- Excellent communication and presentation skills required.
- Proficient in standard Microsoft Office tools: Word, Excel, and PowerPoint.
- Strong attention to detail and organizations skills.
- Prior drug development experience in nucleic acids-based therapeutics is highly desirable.
- Basic understanding of FDA and ICH Guidance for bioanalysis and ADA evaluation.
- Experience in LC/MS based analysis, especially high-resolution LC/MS analysis, is a plus.
Benefits & Compensation:
Stoke Therapeutics offers comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Primary Caregiver Leave; a 401K program with company match, and an Employee Stock Purchase Program (ESPP). Compensation will be highly competitive for the industry and directly commensurate with experience.
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is based in Bedford, MA.