Job Posting

Director, MSAT

Reporting to: VP, CMC

Location: San Francisco Bay Area

About us

Ray Therapeutics is developing novel optogenetics gene therapies for patients with blinding diseases. The company is developing its lead candidate RTx-015 in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need. The company’s mission is to use optogenetics to restore vision, independent of genetic mutation for patients with inherited retinal diseases. Ray Therapeutics is based in the San Francisco Bay Area. For additional information, please visit our About Us page.

Position Summary:

We are currently seeking an exceptional individual as Director, Manufacturing Sciences, Analytics and Technology (MSAT) to join our team in the mission to restore vision to patients. The Director, MSAT will work closely with and report to our VP, CMC in all aspects of manufacturing from research through pivotal stage manufacturing. The position requires hands on AAV manufacturing 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.

Essential Duties and Responsibilities:

Develop, discuss, and drive CMC plans from research to pre-IND and later phase development including pivotal Phase 2/3 studies
Serve as point of contact with CMO vendor
Review and provide technical feedback on CDMO GMP documentation including, but not limited to master production records, test procedures, deviations, CAPAs and completed records.
Build internal manufacturing tracking and trending system including in-process and release testing results as well as manufacturing process parameters and raw materials.
Track CMC deliverables and to ensure strategies and plans are incorporated into full program development plans by working with project management team.
Proactively outline risk and mitigations and communicate all to internal team
Provide regular updates to leadership team on progress, data, risks, and forecasting of future CMC project needs
Provide input on project plans for research, nonclinical, and GMP AAV manufacturing

Qualifications and Experience:

Bust have a degree in relevant scientific or engineering discipline with 10+ years relevant biotech experience
Hands on experience in AAV gene therapy manufacturing required
Knowledge of AAV analytical methods and testing
Experience as part of or managing external CDMOs
Experience with manufacturing tracking and trending or statistical process control
Excellent scientific knowledge and acumen
10+ 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

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