DMPK at Talent Boston, Massachusetts

Senior Scientist

We are seeking a Senior Scientist to lead bioanalytical assay development supporting DMPK and immunogenicity for oligonucleotide therapeutics. This role plays a key part in advancing drug candidates from early research through clinical development and regulatory submission.
Key Responsibilities:
PhD in Analytical Chemistry, Biochemistry, or related field
3-5 years of bioanalytical/analytical lab experience
Strong expertise in oligonucleotide bioanalysis and complex biological matrices
Experience with GLP/GCP, regulatory guidelines, and CRO management
Need experience in LC-MS work did you personally run?
Need to describe a bioanalytical assay you developed or validated yourself from start to finish?
LC-MS work directly support an IND, GLP, or GCP study? If yes, how?
Develop, optimize, and validate PK and ADA assays (LC-MS/MS, ELISA, qPCR)
Lead bioanalytical strategies for oligonucleotides (siRNA, ASO, conjugates)
Manage CROs for assay development, transfer, and sample analysis
Analyze and interpret PK, ADA, and PK/PD data for nonclinical and clinical studies
Support study design, regulatory submissions (IND/NDA), and ensure ICH M10 compliance
Collaborate cross-functionally with clinical, translational, and nonclinical teams