Scientist, CMC Analytical Development

Location
South San Francisco, CA
Posted
Mar 27, 2019
Ref
2019UB001
Required Education
Doctorate/PHD/MD
Position Type
Full time

About Audentes Therapeutics

Audentes Therapeutics is a biotechnology company committed to the development and commercialization of innovative new gene therapy treatments for people with serious rare diseases. We believe gene therapy technology has tremendous potential as a treatment approach for many genetic diseases. We currently have four programs in development for the treatment of X-Linked Myotubular Myopathy (XLMTM), Crigler-Najjar Syndrome Type 1 (CN Type 1), CASQ2-related Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) and Pompe disease. We are a focused, experienced and passionate team driven by the goal of improving the lives of patients.

Listed below is a current opening for which we are seeking smart, driven, experienced, and just plain nice people to join us in realizing Audentes' mission.  Audentes takes pride in strong, global relationships with the patient, research, and medical communities, and we take equal pride in carefully selecting our colleagues. If you believe you match what we're looking for, we'd love to hear from you. Our compensation philosophy embodies what you'd expect from an innovative life sciences employer competing for the best talent available.

The Role

Reporting to the Scientist II of CMC Analytical Development, the Scientist will be responsible for independently developing and qualifying cell-based assays for the determination of the potency of AAV vector products. Many of our programs involve proteins of poorly known function, so creativity is required to develop an assay that assesses the function of the transduced protein.  In addition, the oversight of CRO's will be a responsibility of this position. The position will be in our newly opened laboratories in South San Francisco.

Specific responsibilities include:

  • Ability to use literature to design proof of concept experiments for assays that measure either relevant  viral attributes, or the function of a transduced protein.
  • Developing cell based in-vitro potency assays for AAV products with either an ELISA, ddPCR/qPCR, or a protein functional readout.
  • Participation in transfer and validation activities for cell-based in-vitro potency assays.
  • Management and oversight of analytical activities at third party contract research organizations (CROs), including interfacing for assay transfer, validation and sample handling

Required Education, Skills & Experience

  • PhD in Virology/Immunology/Biology with 3+ years' post-graduate experience
  • Proven experience with the culture of multiple mammalian cell lines
  • Demonstrated prior experience developing Elisa, qPCR, Cell based in-vitro, Western Blot and other gene therapy vector characterization assays
  • Successful track record working with early development programs in a regulated environment
  • Strong written and verbal communication skills, with the ability to clearly articulate complex concepts and strategies
  • Demonstrated leadership and critical thinking skills

Preferred Skills & Experience

  • Experience managing and overseeing analytical activities at third party contract research organizations (CROs), including interfacing for assay transfer, validation and sample handling
  • Track record of success as demonstrated by successful regulatory submissions (e.g., IND CTA, BLA), peer-reviewed publications and/or presentation at industry meetings
  • Expertise in drug discovery and development with AAV-based therapeutics