Senior Scientist, Assay Development Cell Biology

Redwood City, CA 94063

Posted: 02/07/2020 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 17105

Job Description


 

Job Description

Senior Scientist, Assay Development Cell Biology

 

What You’ ll Do
  • Plan strategies for and participate in the development, qualification, and transfer of quantitative and semi-quantitative cell-based bioanalytical methods to support product release
  • May also contribute to development, qualification, and transfer of molecular biology bioanalytical methods to support preclinical and clinical assays
  • 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 contract research organizations
  • Supervise a group of scientists
  • Maintain a detailed awareness of industry guidance and standards for assay validation and performance
  • Maintain current knowledge of advancing technologies and propose their applications to ongoing projects.
  • Author standard test methods and best-practices documents for the Assay Development group
  • Contribute to development reports
  • Contribute to CMC protocols and regulatory reports
  • Independently plan, implement, and complete significant projects with minimal supervision.
  • 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.
  • Oversee writing of test procedures, documented standard test methods, SOPs, protocols, and technical reports.
  • Present project status updates in internal and external forums. Participate in scientific meetings and produce original peer-reviewed publications.
  • Maintain excellent documentation of laboratory activities.
  • Other responsibilities may be assigned as needed.

About You
  • PhD degree and 8+ years relevant biotechnology industry experience, Master’ s degree and 12+ years relevant biotechnology industry experience.  Bachelor’ s degree with exceptional experience in biologics assay development and 20+ years relevant biotechnology industry experience
  • Supervisory experience is required.
  • Experience in developing and validating cell-based product release and bioanalytical assays is required. Knowledge of FDA requirements desired.
  • Experience working as part of a project team
  • Understanding of QC assay requirements
  • Ability to read and extract information from published literature and internal reports is required.
  • Expertise is required in cell line development and cell-based assays (sterile tissue culture techniques, transfection, transduction, maintaining, subcloning, and banking cells).
  • Knowledge of techniques such as flow cytometry and immunofluorescence are strongly desired.
  • Broad knowledge of cell assay methods and biochemistry with application to gene therapy (for example, neutralizing antibody assays) is strongly desired.
  • Background in the area of retinal or genetic diseases is desired; an understanding of AAV biology is 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 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 presentation at a conference is desired.
  • Proficiency with SoftMaxPro, GraphPad Prism, JMP, and other common analytical software desired.
  • Proficient with MS Office and other common office software.

 

Meet Your Recruiter

Jesse Ashworth

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