Scientist I, Biophysical Characterization (mb)

Location
Redwood City, CA
Posted
Jun 03, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Adverum is looking for a Scientist I to join our team in our Redwood City office. This position reports to Director-level personnel in Assay Development.  This person will be working with Assay Development, Quality Control, Process Development, Preclinical, and Clinical teams. This role is responsible for developing, qualifying, transferring, documenting, and troubleshooting product characterization and bioanalytical assays using biophysical technologies.
 
What you'll do:
  • Participate in the development, qualification, validation, and transfer of quantitative and semi-quantitative biophysical characterization assays to support product release as well as preclinical, and clinical sample bioanalysis
  • Evaluate, implement, and maintain new technology within Assay Development to support product release and sample bioanalysis
  • 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 outside vendors
  • Maintain a detailed awareness of industry regulatory 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.
  • Serve as SME for biophysical assay technologies
  • Participate in scientific meetings and produce original peer-reviewed publications
  • Maintain excellent laboratory notebook documentation
  • Mentor junior scientists
  • Other responsibilities may be assigned as needed

About you:
  • Sr. Scientist level - PhD degree and 8+ years of relevant biotechnology industry experience, Master’s degree and 15+ years of relevant biotechnology industry experience, or Bachelor’s degree and 20+ years of relevant biotechnology industry experience
  • Scientist level - PhD degree and 2+ years of relevant biotechnology industry experience, Master’s degree and 10+ years of relevant biotechnology industry experience, or Bachelor’s degree and 15+ years of relevant biotechnology industry experience
  • Experience working as part of a project team
  • Experience mentoring a group of lab personnel at various levels
  • Understanding of QC assay requirements
  • Understanding of requirements for pharmacokinetic assays
  • Extensive experience in assay development, troubleshooting, validation, qualification, and transfer
  • Working knowledge in developing large-molecule and biologics assays in a regulated environment to support some or all of the following: light scattering, AUC, DSF, SPR, LCMS, or other biophysical assay technologies.
  • Experience in enzyme assays and LBA techniques is a plus.
  • Broad knowledge of gene therapy discovery and regulatory guidelines is desired
  • Background in the area of AAV characterization a plus
  • Peer-reviewed publications in the area of assay development a plus
  • Working knowledge of basic statistics
  • Knowledge of MicroSoft Office Suite. Experience with SoftMax Pro a plus. Experience with GraphPad Prism a plus. Experience with JMP a plus.



About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self.  We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation