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 companys 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