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Sr. Research Associate II

The Steely Group

Novato, CA

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JOB DETAILS
SKILLS
Analysis Skills, Antibodies, Assays, Biomarkers, Clinical Research, Contract Research Organization (CRO), Data Analysis, Data Collection, Data Management, Drug Development, Establish Priorities, GLP (Good Laboratory Practices), Identify Issues, Ligand Binding, Multiplatform/Cross-Platform, Multiplexing, Multitasking, Organizational Skills, Pharmacokinetics, Polymerase Chain Reaction (PCR), Regulations, Regulatory Compliance, Reporting Skills, Statistical Analysis System (SAS), Statistics Software, Team Player, Technical Support, Technical Writing, Time Management, Translational Research, Validation Plan, Writing Skills
LOCATION
Novato, CA
POSTED
7 days ago

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

About the Company

T

The Steely Group

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