Responsibilities:
- Design, develop, and optimize ligand-binding assays (e.g., ELISA, MSD, Gyros) to quantify monoclonal antibodies in biological fluids.
- Perform fit-for-purpose bioanalytical method work per internal SOPs and global regulatory guidelines; evaluate accuracy, precision, selectivity, sensitivity, and stability.
- Analyze preclinical and clinical study samples to provide high-quality data.
- Characterize, conjugate, and manage critical reagents (capture/detection antibodies, standards) for long-term assay consistency.
- Independently troubleshoot assays; evaluate and implement new technologies to improve sensitivity, throughput, and robustness.
- Document procedures/results in an electronic lab notebook (ELN).
- Collaborate cross-functionally and communicate effectively.
Required Qualifications:
- Ph.D. in Immunology, Biochemistry, Biology, or related field; OR M.S. with 3+ years industry experience; OR B.S. with 5+ years industry experience.
- Hands-on experience developing/validating/running ligand-binding assays (LBAs).
- Knowledge of pharmacokinetics principles for biologic drugs.
- Immunoassay platform proficiency; ELISA experience minimum.
Preferred Qualifications:
- Experience with MSD, Gyros, or Quanterix.
- ADA (anti-drug antibody) assay development/validation experience.
- Cell-based neutralizing antibody (NAb) assay familiarity.
- Data analysis skills; e.g., SoftMax Pro, Benchling.
- Strong problem-solving and scientific rigor.
Benefits:
- Multiple relocation packages; two weeklong shutdowns in the US (mid-summer/year-end, in addition to PTO); 8-week parental leave; 9 Employee Resource Groups; annual bonus offering; flexible work arrangements; up to 6% 401K matching.