Senior Scientist, Assay Development Cell Biology
Adverum is looking for a Senior Scientist with knowledge of cell biology to join our team in our Redwood City office. This position reports to the Senior Director of Assay Development and Bioanalytics. This person will be working cross functionally with Assay Development, QC, and Process Development groups. This role is responsible for overseeing and planning strategy for developing, qualifying, transferring, and troubleshooting cell-based assays in support of product characterization/release and bioanalysis.
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.
- 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.