Associate Scientist, Assay Development
Adverum Biotechnologies is a gene therapy company committed to discovering and developing novel therapeutics that can offer life-changing benefits to patients living with rare diseases or diseases of the eye who currently have limited or burdensome treatment options. This is a technical position for a highly motivated Associate Scientist for our Assay Development team to provide support for our Research and Development group. The right candidate would particularly be involved in quantitative assay development and performance in a variety of formats in support of pharmacokinetics, pharmacodynamics, and product release.
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.
- Participate in the transfer of processes, technology, and assays to/from internal and external collaborators and outside vendors
- 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. Experience with GraphPad Prism a plus. Experience with JMP a plus.
- Peer-reviewed publications in the area of assay development a plus