Scientist II Bioanalytical Assay Manager
1 DNA Way S San Francisco, CA 94080 US
Job Description
Description
A Bioanalytical Assay Manager is a highly motivated and collaborative individual who participates in the evaluation of validation/qualification reports as well as oversight of assay transfer, feasibility, lifecycle management of immunoassays and mass spectrometry assays to measure biomarkers at Contract Research Organization (CRO) in support of pre-clinical and clinical studies. This individual will work across the organization to help harmonize CRO, platform and assay selection and use. This job does not involve hands-on work in the laboratory. Responsibilities:
- Review of validation/qualification documents and bioanalytical reports
- Assist with the transfer of reagents and method documentation, assay transfer and sample analysis plans, from feasibility to validation/qualification
- Assist with the experimental design and protocol language, evaluate project team data to ensure integrity from a technical perspective and troubleshoot technical problems at the CROs, review CRO technical reports, and may present at BAS working groups
- Support and provide oversight of assay life cycle management at CROs, which will require critical reagent forecasting, requesting of new reagent preparation [within and external to Bioanalytical Sciences Department (BAS)] and shipment to the CRO, review of reagent incorporation/troubleshooting, reagent re-test date extension.
- May be required to attend and participate in technical teleconference with CROs and internal BAS bioanalytical and safety biomarker working groups
- Register and maintain assays in internal database systems and webpages
Requirements:
- B.S. in Biological Sciences or equivalent with a 3 to 5 years hands-on laboratory experience in developing/qualifying quantitative ligand binding methods.
- Familiarity with biochemistry, cellular and molecular biology methods, new analytical technologies, Project management software would be an important advantage. Practical knowledge and understanding of computerized data handling are essential.
- Expected on-campus average of 3-days a week with some flexibility.
- Excellent communication (email, phone, teleconference), interpersonal, and organizational skills are essential. This individual must be a good team player able to work in a fast-paced and highly collaborative environment and be able to work independently as well as on a team. They should be able to multi-task and prioritize work well, and to consistently demonstrate initiative and creativity.
Pay Rate Range: $65-85/hr depending on experience
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About S San Francisco, CA
Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.