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.

The Role

The Director, Analytical Development will lead all aspects of analytical method development, validation and testing of drug substance and drug product at CDMOs and contract testing labs. They will lead Analytical R&D, Quality Control, and Stability internally and at CDMOs/contract testing labs. They will manage and coordinate effectively the assay development and quality control deliverables and milestones for analytical projects and ensure successful and timely completion. Importantly, this individual will select and oversee analytical and characterization contract testing laboratories. The Director Analytical will review analytical data from contract partners, provide feedback and facilitate resolution of technical or quality issues. The successful candidate will also have responsibility for authoring technical reports, deviations, change controls, and analytical sections of regulatory filings.

Key Deliverables

Transfer OP-101 methods to CMO.  Transfer D-4517.2 method to CMO for Ph2 batches.  Develop methods for next clinical candidate beginning in Q3 at US contract testing lab for GLP tox/Ph1

Skills and Experience

B.S Degree in a related Discipline.  Expertise in mass spectrometry, chromatography (e.g. SEC, RP-HPLC, HIC, IEX), and NMR techniques.  Expertise in SEC-MALS, dynamic laser light scattering, and ICP-MS.  Experience in analytical method development and qualification/validation for GMP quality control testing along with analyzing antibody drug conjugates or small molecule is preferred.   Hands-on experience with outsourcing of assay development, characterization and testing in support of CMC activities.  Knowledge of regulatory environment (ICH/FDA/EMA regulations) and experience with organizing and writing regulatory submissions.

Please note, candidates must be able to work on site at our Redwood City office a minimum of 2-3 days per week