Associate Director, Analytical Sciences

Job Description

ORIC Pharmaceuticals, Inc, is a clinical stage oncology company dedicated to improving patients’ lives and focused on developing treatments that address mechanisms of therapeutic resistance. We are seeking a highly motivated analytical research and development scientist with a proven record of sustained laboratory achievement and innovation to join our growing CMC group at ORIC Pharmaceuticals. The candidate will be part of cross-functional teams providing analytical leadership on projects, working closely on a shared mission to bring new therapeutics to cancer patients.

The successful candidate will report to the Sr. Director of Analytical Sciences and will be responsible for :

• Management of outsourced and in-house research activities. Function as a subject matter expert for tech transfer / development of processes to external vendors and CMOs. Create and execute plans for external projects by providing technical guidance, strategic and tactical direction, and oversight to ensure the product requirements are designed and delivered appropriately and in a timely manner for all the stakeholders and customers, across all the stages of drug development - from discovery through preclinical to clinical and commercial.
• Independently lead and provide oversight for analytical method development, solid state characterization, validation, release, and stability testing activities at CDMOs and in-house.
• Management of GMP manufacturing and product characterization activities at external partners including preparation and review of analytical methods, Method Validation Protocols, Method Validation Reports, Stability protocols and CoAs; work closely with process and formulation colleagues to propose specifications for RSMs, IPCs, intermediates, API and DP based upon batch history data and control strategy.
• Manage and provide technical guidance during investigations / quality events at CDMOs / CROs in collaboration with quality.
• Author and review technical reports, technical data packages, and relevant sections in health authority filings (including INDs, NDAs, annual reports, and any other regulatory interactions), and contribute to regulatory filing strategy.
• Prepare presentation materials and clearly communicate research results to manager, and at internal / external meetings.
• Work cross-functionally with Regulatory, Quality, Pre-clinical, Process and Formulations Development colleagues.
• Maintain oversight of batch genealogy, stability, and test results to ensure all information is appropriately archived, readily available, and is transformed into useful knowledge and understanding.
• Work closely with formulation and process colleagues for CMO selection, enablement and troubleshooting at site, and tech transfer. Proactively coordinate and work with CROs, CDMOs, and CMOs ensuring smooth tech transfer, uninterrupted clinical supplies.
• Communication excellence in managing projects and deliverables, including budget planning, oversight in partnership with cross-functional colleagues, periodic organization and documentation of progress and accruals, and contract / PO / invoice coordination with finance.

Qualifications

Additional Information

All your information will be kept confidential according to EEO guidelines.