Job Posting

Director, CMC Analytics

Reporting to: VP, CMC

Location: San Francisco Bay Area

About us

Ray Therapeutics mission is to restore vision to people with retinal degenerations. RayTx is using a novel bioengineered optogenetic protein optimized for human vision delivered by AAV to restore visual function in a mutation agnostic approach and without the need for light enhancing eyewear. The company is developing its lead candidate RTx-015 in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need as well as a pipeline to treat both rare and large market indications. Ray Therapeutics is based in the San Francisco Bay Area. For additional information, please visit www.raytherapeutics.com.

Position Summary:

We are currently seeking an exceptional leader as Director, CMC Analytics to join our team in the mission to restore vision to patients. The Director, CMC Analytics, will work closely with and report to our VP, CMC in all aspects of outsourced early and late phase/commercial analytical sciences, development and QC testing for our AAV optogenetic therapeutic products. The position requires hands on GMP AAV analytical experience with the ability to be a team player both internally as well as with our external partners. The role is based in the Berkeley, CA office with a hybrid work from home/in office requirement and will require travel to our contract development and manufacturing organizations in the United States.

  • Provide input into CMC analytical plans from research to pre-IND and later phase development including pivotal Phase 2/3 studies.
  • Serve a point of contact with CDMO vendor for analytical subject matter.
  • Review and provide technical feedback on CDMO GMP documentation including, but not limited to master production records, test procedures, analytical method protocols and reports, deviations, CAPAs and completed records.
  • Collaborate with internal and external teams to build manufacturing tracking and trending system including in-process and release testing results.
  • Lead analytical method development, qualification and validation activities that are performed at CDMO and other contract laboratories.
  • Lead analytical method transfer from internal R&D group to contract laboratories as needed.
  • Track CMC analytical deliverables and to ensure strategies and plans are incorporated into full program development plans by working with project management team.
  • Provide input into risk mitigation and communicate to internal team
  • Provide regular updates to leadership team on progress, data, risks, and forecasting of future CMC analytical project needs

Provide CMC analytical input on project plans for research, nonclinical, and clinical programs.

Essential Duties and Responsibilities:

  • Provide input into CMC analytical plans from research to pre-IND and later phase development including pivotal Phase 2/3 studies.
  • Serve a point of contact with CDMO vendor for analytical subject matter.
  • Review and provide technical feedback on CDMO GMP documentation including, but not limited to master production records, test procedures, analytical method protocols and reports, deviations, CAPAs and completed records.
  • Collaborate with internal and external teams to build manufacturing tracking and trending system including in-process and release testing results.
  • Lead analytical method development, qualification and validation activities that are performed at CDMO and other contract laboratories.
  • Lead analytical method transfer from internal R&D group to contract laboratories as needed.
  • Track CMC analytical deliverables and to ensure strategies and plans are incorporated into full program development plans by working with project management team.
  • Provide input into risk mitigation and communicate to internal team
  • Provide regular updates to leadership team on progress, data, risks, and forecasting of future CMC analytical project needs
  • Provide CMC analytical input on project plans for research, nonclinical, and clinical programs.

Qualifications and Experience:

  • Bust have a degree in relevant scientific or engineering discipline with 8+ years relevant biotech experience
  • Hands on experience in GMP AAV gene therapy analytical methods and testing
  • Hands on experience with molecular biology, protein, chemical and cell based assays
  • Deep understanding of analytical method qualifications and validations
  • Specification setting experience using statistical based methods for small sample sizes
  • Late phase GMP AAV manufacturing experience preferred
  • Experience as part of or managing external CDMOs
  • Excellent scientific knowledge and acumen
  • 8+ years of industry experience with a proven track record of success

Working Conditions:

  • Prolonged periods of being at a stationary desk or work computer
  • Ability to occasionally adjust, handle, or move objects up to 20 pounds
  • Ability to assess the accuracy, neatness, and/or thoroughness of the work assigned
  • Travel up to 30% within the United States

Ray Therapeutics does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual’s status in any group or class protected by applicable federal, state, and local law. We invite applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Ray Therapeutics offers a competitive total rewards package that includes a market competitive base salary, target bonus, and equity in addition to health care benefits.

Please submit please submit your resume and cover letter to: careers@raytherapeutics.com