San Mateo Metro Area, CA
In support of gene therapy drug products in preclinical and clinical development. The candidate will primarily develop, optimize and help qualify ELISA, enzyme activity, and immunogenicity assays, possibly including cell-based assays.
The candidate will work collaboratively with different research and development departments to evaluate and implement new assay formats and/or technologies. In addition, the candidate will be expected to perform some testing as needed in support of product characterization.
Responsibilities will also include routine lab maintenance, writing test procedures, SOPs, protocols, technical reports, and summarizing/presenting data at internal and external meetings. Maintaining good documentation is required.
Participate in the development and qualification of quantitative and semi-quantitative bioanalytical methods to support product release, pharmacokinetic, and immunogenicity assessments
Present results, conclusions, and implications to project teams and senior management.
Maintain a detailed awareness of industry guidance and standards for assay validation and performance
May serve as Principal Investigator for assays supporting GLP studies
Contribute to development reports
Contribute to nonclinical and clinical study protocols and regulatory reports
Independently carry out the aforementioned tasks and plan, implement, and complete significant projects with minimal supervision.
Participate in scientific meetings and produce original peer-reviewed publications
Bachelor s degree (advanced degree a plus) and 5+ years biotechnology industry experience
Experience working as part of a project team
Experience in developing large-molecule assays in a regulated environment
Working knowledge of basic statistics
Knowledge of MicroSoft Office Suite. Experience with SoftMax Pro a plus.