Scientist, Immunoassay/ADA Assay Development

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.

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