Who We Are
Ashvattha Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel hydroxyl dendrimer (HD) therapeutics (HDTs) to treat unmet medical needs in oncology, ophthalmology, and inflammatory diseases. We believe that HDTs will become the future of targeted therapeutics and unlock new levels of patient care.
Manage Contract Development and Manufacturing Organizations (CDMOs) for process technology transfer and optimization, non GMP and cGMP manufacture, and supply of Intermediates and Drug Substance (DS) in support of ongoing and new clinical programs.
Support Technical Transfer of Intermediates and Drug Substance processes to CDMOs.
Support Drug Substance process optimization, scale-up and validation activities. Prepare/edit and review cGMP batch records and other quality documents. Execute tactical and strategic plans in accordance with cGMP, ICH, EMA, and FDA regulations. Author and review relevant sections for regulatory submissions. Manage Drug Substance manufacturing
Skills and Experience
BS degree in a related discipline. Experience managing small molecule drug substance manufacturing at CDMOs/CMOs along with the ability to build successful, collaborative relationships with CMOs. Knowledge of US and European cGMP guidelines and requirements. Experience on previous INDs, NDAs and other regulatory filings.
Must be able to work onsite at our Redwood City facility 2-3 days per week.