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.