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.
Location(s):
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is based in Bedford, MA.