Job Description
Job Description
The Bioanalytical Development group seeks a highly motivated Senior Research Associate II to provide Bioanalytical and Biomarker method development in support of the Translational Research team as well as programs in non-clinical and clinical development.
Our client develops, transfers and/or validate bioanalytical methods for quantifying biotherapeutic proteins, biomarkers, and anti-dug antibodies in both regulated and non-regulated environment. The data and expertise enable characterization of immunogenicity, pharmacokinetic, and biological activities of company’s biotherapeutics during all phases of drug development.
Responsibilities:
- Develop, optimize, qualify, and perform bioanalytical assays to support PK, immunogenicity, and biomarker analysis of biotherapeutic programs
- Design and execute ligand-binding assays, hybrid assays, and cell-based assays for non-clinical research and early clinical development
- Support technology transfer of assays to internal groups and contract research organizations (CROs)
- Contribute to method qualification, validation, and sample analysis in compliance with regulatory expectations
- Analyze, compile, and interpret data from multiple assay platforms and studies
- Present results clearly through reports, presentations, and discussions with internal and external stakeholders
- Assist in author and review of technical documents including sample analysis plans, method development reports, validation protocols/reports, and study reports.
- Effectively prioritize and manage workload across diverse assay types and timelines.
- Independently troubleshoot complex technical issues and develop creative solutions.
- Ensure that bioanalytical activities relating to regulatory commitments are supported with quality data and in the time expected. Contribute to writing regulatory documents as needed.
- Investigate and implement new analytical methods, technologies, and platforms to enhance assay performance and capabilities
Requirements / Qualifications:
- SRA II: MS in Chemistry, Biochemistry, Biology, Immunology, or equivalent with 4-6 years of related experience; or a BS with 6-8 years of related experience
- Experience developing and qualifying ADA, PK, NAb and biomarker assays
- Experience in a broad range of protein techniques including Western, ELISA, multiplexing platforms such as MSD/Luminex, protein expression, PCR, antibody development/characterization
- Demonstrate independence at the bench and ability to work collaboratively on projects
- Experience with data management systems, familiarity with data and statistical analysis software
- Position requires excellent organizational skills and time management to meet deadlines in a fast-paced organization. Ability to multitask and work on diverse projects is an advantage
- Familiarity with regulatory and industry guidance documents including requirements for GLP bioanalytical assays