Biological Researcher I

Role Summary

Biological Researcher I in the Bioassay Department of Biologics CMC. Performs method development, troubleshooting, routine sample testing, and method qualification of PCR and ELISA-based assays to support both clinical and commercial programs. This role involves collaborating with cross-functional teams and may support regulatory submissions. Reports to an Associate Director of the Bioassay Department.

Responsibilities

• Conduct routine sample testing and analysis of biologic products using quantitative PCR and ELISA-based methods.
• Develop, qualify, transfer, and troubleshoot quantitative PCR and ELISA-based methods to internal and external GxP laboratories.
• Author and review SOPs, protocols, laboratory notebook entries, and technical reports.
• Actively manage and maintain lab supplies and critical reagents (ordering/inventory/characterization).
• Participate in project meetings providing insights and status updates to the larger cross-functional team.
• Present data at internal/external meetings as needed.

Qualifications

• Minimum of 1 year pharmaceutical industry experience.
• Preferred experience in quantitative PCR and ELISA-based assays according to current industry standards to support biologics product testing, specifically monoclonal antibodies.
• Flexible and adaptable: fast-paced environment with changing timelines/priorities.
• Meticulous attention to detail in following procedures, preparing written documentation, and execution of experiments.
• Clear communication skills: able to share data and communicate issues/complications clearly.
• Highly cooperative/team player in a matrixed lab environment (shared responsibilities).

Education

• B.S. in Molecular Biology, Biotechnology or related field

Skills

• Quantitative PCR and ELISA-based assay techniques
• Authoring and reviewing SOPs, protocols, and technical reports
• Written and verbal communication
• Collaborative teamwork in cross-functional environments
• Laboratory supply management and reagent characterization