1035 O'Brien Drive
Industry: Clinical & Scientific
Job Number: 16302
Associate Scientist, Assay Development
Menlo Park, CA
Our Assay Development team is looking to bring onboard an Associate Scientist. This individual will support the Assay Development team through quantitative assay development and performance in a variety of formats in support of product release as well as pharmacokinetics and pharmacodynamics.
Core Duties and Responsibilities
- Work with senior scientific personnel to design, develop, qualify or validate, troubleshoot, and transfer ligand-binding assays, enzyme activity assays, immunogenicity assays, and product characterization assays to internal and external scientists and support the development of cell-based assays
- Participate in decisions on experimental approaches and interpretation of data
- Work collaboratively with different research and development departments to evaluate and implement new assay formats and/or technologies
- Transfer of assays to and oversee work at Contract Research Organizations and with the QC group
- Maintain current knowledge of regulatory requirements for bioanalytical and product characterization assays
- Write test procedures, SOPs, protocols, and technical reports.
- Present project status updates in internal forums
- May perform some internal sample analysis needed in support of product characterization and preclinical studies
- Maintain excellent documentation of laboratory activities
- Perform routine lab maintenance
Position Requirements and Experience:
- Minimum of a biological science bachelor’ s degree with 4-5 years’ experience in a biotech company, or a master’ s degree with 2-3 years’ experience, or an equivalent combination of education and experience
- Experience in assay development is required
- Expertise in a variety of laboratory techniques involving protein analysis including analyte quantitation such as ELISA, MSD, and similar, Western blotting, and immunogenicity assays, potency assays is required. Experience with sterile tissue culture techniques (transfection, transduction, maintaining cell lines) is a plus.
- Experience in biochemical techniques such as LCMS, flow cytometry, and immunofluorescence is strongly desired
- Experience with analysis of proteins in mammalian tissues is preferred.
- Experience in the qualification/validation of quantitative assays and FDA requirements for these is desired.
- Broad knowledge of protein assay methods and biochemistry with application to gene therapy is strongly desired. Ability to read and extract information from published literature and internal reports is required.
- Background in the area of retinal or genetic diseases is desired, with an understanding of AAV biology a plus
- Must be a self-starter, proactive, co-operative, and proficient at working both independently and in a small team environment
- Proven initiative and demonstrated accountability in a fast-paced environment with high degree of flexibility.
- Detail oriented and with time management skills
- Excellent verbal and written communication skills. Experience in presenting data through written reports and oral presentation.
- Publication in a peer-reviewed journal or having presented at a conference is desired
- Proficiency with SoftMaxPro, GraphPad Prism, and other common analytical software desired
- Proficient with MS Office and other common office software