Sr. Scientist I/II
Seeking a Sr. Scientist I/II to assist in preclinical and clinical development. The candidate will primarily develop, optimize and help qualify ELISA, enzyme activity, and immunogenicity 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, and technical reports
- Participate in the development and qualification of quantitative and semi-quantitative bioanalytical methods to support product release, pharmacokinetic, and immunogenicity assessments
- 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
- B.S./M.S./PhD with 5+ years cell based assay development and viruses 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 MicroSoftt Office Suite. Experience with SoftMax Pro/ GraphPad Prism/JMP a plus.