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Scientific. Clinical. Software Engineering

Associate Scientist

San Mateo Metro Area, CA

Job Number: JN -042020-26653 Region: San Mateo Metro Area

Job Description

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.

Position Responsibilities:

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

Position Requirements:

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.

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