What are the responsibilities and job description for the Senior Scientist Bioanalytical Development position at Talent Groups?
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 expereince in LC‑MS work did you personally run?
- Need 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
Salary : $85 - $90