QC Analyst I

Redwood City, CA
Apr 18, 2021
Quality, Quality Control
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Adverum is looking for a Quality Control Analyst I to join our team in our Redwood City office. This position reports into the Quality Control Manager.  This person will be working with the QC team and cross-functionally.  This individual will be a crucial member of the Quality Control team, contributing to the development and performance Quality Control (QC) methods, systems, policies, processes, procedures and controls as they relate to the analytical testing of clinical materials. 
What you'll do:
  • The Quality Control Analyst is responsible for release testing in support of nonclinical and clinical viral vector products in compliance with GxP requirements.
  • Understands and follows standard operating procedures (SOPs).
  • Performs release, stability, and in-process testing of materials, samples, and final products; works with mammalian samples and cell cultures.
  • Performs analysis and interpretation of test results, identifies deviations, and makes appropriate recommendations.
  • Participates in method and equipment qualification/validation studies; generates protocols, executes and coordinates experiments, and drafts reports.
  • May assist in assay development and nonclinical sample testing to support IND-path studies.
  • Other responsibilities may be assigned as needed

About you:
  • Relevant scientific degree with minimum 0-3 years of experience in a bio-pharma analytical laboratory.
  • Experience in quality control desired.  A strong background in molecular biology is desired. Experience with viral vector (adeno-associated virus) product is a plus.
  • Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries desired. Must have laboratory experience with a variety of analytical techniques including, but not limited to, quantitative and/or digital PCR, ELISA, and cell-based methods.
  • Knowledge of statistical methods applicable to the analysis of experimental data.
  • Proficient in general and non-routine laboratory skills.
  • Excellent interpersonal, communication and organizational skills.
  • Flexibility in problem solving to meet business objectives. Good oral and written communication skills. MS Office skills; equipment related software such as Soft Max Pro desired.

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