Senior Research Associate Ii

Overview

• Play a pivotal role in advancing bioanalytical and biomarker methods for groundbreaking drug development initiatives.
• Develop and validate innovative bioanalytical assays to support regulatory and non-regulatory research environments.
• Collaborate with internal teams and external partners to ensure seamless technology transfer and project execution.
• Analyze and interpret complex data from diverse assay platforms to drive impactful research outcomes.
• Present findings through comprehensive reports, presentations, and stakeholder discussions.
• Investigate and implement cutting-edge analytical methods to enhance assay performance and reliability.
• Ensure compliance with regulatory standards and contribute to the preparation of regulatory documentation.
• Engage in a dynamic research environment fostering innovation and professional growth.

Key Responsibilities & Duties

• Design, develop, and qualify bioanalytical assays for pharmacokinetics, immunogenicity, and biomarker analysis.
• Execute ligand-binding, hybrid, and cell-based assays to support research and clinical development.
• Facilitate assay technology transfer to internal teams and external contract research organizations.
• Contribute to method qualification, validation, and sample analysis adhering to regulatory guidelines.
• Analyze data from multiple platforms, ensuring accurate and effective presentation of results.
• Author and review technical documents, including validation protocols and development reports.
• Troubleshoot technical challenges and develop innovative solutions independently.
• Investigate emerging methods and technologies to enhance assay capabilities and efficiency.

Job Requirements

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Biology, Immunology, or related field.
• 4-8 years of experience in bioanalytical assay development and qualification.
• Proficiency in ADA, PK, NAb, and biomarker assay techniques.
• Experience with protein techniques such as ELISA, MSD/Luminex, PCR, and antibody development.
• Strong organizational skills and ability to multitask in a fast-paced environment.
• Familiarity with regulatory guidance documents for GLP bioanalytical assays.
• Competence in data management systems and statistical analysis software.
• Ability to work collaboratively and independently on diverse projects.