Director, CMC Analytics

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, for 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.

We are currently seeking an exceptional leader for the role of 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 of CMC on 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 and the ability to collaborate both internally and with external partners. The role is based in our Berkeley, CA office, with a hybrid work-from-home/in-office arrangement, and will require travel to our contract development and manufacturing organizations within the United States.

• Provide input into CMC analytical plans from research through pre-IND and later-phase development, including pivotal Phase 2/3 studies.
• Serve as the point of contact with CDMO vendors 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 a manufacturing tracking and trending system, including in-process and release testing results.
• Lead analytical method development, qualification, and validation activities performed at CDMOs and other contract laboratories.
• Lead analytical method transfer from internal R&D groups to contract laboratories as needed.
• Track CMC analytical deliverables and ensure strategies and plans are incorporated into full program development plans in coordination with the project management team.
• Provide input into risk mitigation and communicate updates to internal teams.
• Provide regular updates to the 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.

• Must have a degree in a relevant scientific or engineering discipline with 8 years of relevant biotech experience.
• Hands-on experience with 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 qualification and validation.
• Experience in specification setting using statistical methods for small sample sizes.
• Late-phase GMP AAV manufacturing experience preferred.
• Experience working with or managing external CDMOs.
• Excellent scientific knowledge and acumen.
• 8 years of industry experience with a proven track record of success.

• Prolonged periods 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 thoroughness of assigned work.
• 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, or local law. We invite applications from minorities, women, individuals with disabilities, 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 healthcare benefits.