Browse New and Exciting Opportunities
Sr. Research Associate II
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:
- Â SRA II:Â Â 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
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About Novato, CA
Discover Exciting Job Opportunities in the Vibrant Novato, California Area! Novato, nestled in Marin County and conveniently located near San Francisco, offers job seekers a perfect blend of suburban charm and urban excitement. With its picturesque surroundings, proximity to the wine country, and access to stunning parks like Stafford Lake Park and the Marin Museum of Contemporary Art, Novato provides a dynamic backdrop for career growth. Enjoy the renowned cuisine at spots like Boca Tavern or trek the beautiful trails at Mount Burdell. Don't miss the Novato Theater Company productions or catch a game at the Novato Community Athletic Fields. Start your career journey in Novato today and experience the magic this bustling town has to offer.