Director/Associate Director, Process Chemistry
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 process research and development chemist with a proven record of sustained laboratory achievement and innovation to join our growing CMC group at ORIC Pharmaceuticals. The successful candidate will report to the Director of Process Chemistry, and will be responsible for the following;
- Management of outsourced and in-house research activities. Function as a subject matter expert for 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.
- Management of GMP manufacturing activities at external partners including preparation and review of MBRs and EBRs, work closely with AO to support method development and validation, and manage quality event resolution for GMP compliance.
- Author and review technical reports, technical packages, 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.
- Working cross functionally with Regulatory, Quality, Analytical and Formulations Development colleagues.
- Work closely with clinical and preclinical colleagues for need forecasting and supply logistics, including CMO selection, enablement and troubleshooting at site, and tech transfer. Proactively coordinate and work with CROs, CDMOs, and CMOs ensuring uninterrupted clinical supplies. Communication excellence in project management; budget planning, oversight in partnership with quality, regulatory, clinical and preclinical departments. Periodic documentation of progress and accruals, and contract/PO/invoice coordination with finance.
Requirements
- PhD in organic chemistry with 10+ years of relevant hands-on pharmaceutical/biotech industry experience, or equivalent, in the field of new drug discovery and development.
- Proven track record for solving process chemistry problems, including identification, optimization, and characterization of robust and scalable synthetic routes.
- Scientific excellence as demonstrated by publications, presentations, and leadership/engagement in the scientific/professional community.
- Working understanding of analytical tools used in process development (DSC, TGA, DVS, HPLC, NMR, KF, PLM, XRPD).
- Understanding of reaction safety hazards assessment and its application to reaction scale-up.
- Detailed understanding of process characterization in preparation for validation, including experience with using statistical methods for reaction modeling to support filings.
- Experience in tech transfer, scale-up, manufacturing on multikilogram scale, and working in GMP environment.
- Demonstrated ability to work independently and efficiently in a collaborative, fast-paced, integrated, multidisciplinary team environment that includes work internally and with external partners, such as research organizations/Universities, CROs, CMOs, and CDMOs.
- Experience in writing and reviewing batch records, specifications, stability protocols/data review, and development reports.
- Experience in late-stage pharmaceutical and process chemistry drug development, including putting together data and documents towards, authoring/reviewing, and submitting an NDA for a small molecule commercial product highly preferred.
- Awareness and practical understanding of ICH, GMP, and regulatory guidances that are important to consider in new drug product development.
- Demonstrated track record of being an effective manager as demonstrated by lab management, hiring, and mentoring direct reports. Able to work as part of a team with strong interpersonal skills.
- Demonstrated ability to quickly adapt and find creative solutions to ensure deliverables are met, as external environment and stakeholder input evolves.
- Excellent oral and written communication skills. Succinct but thorough communication skills with attention to detail, analytical/critical thinking, and data organization, presentation, and inference.
- Onsite, hybrid, or remote work are all negotiable.
- Level is commensurate with experience.
The anticipated salary range for candidates who will work in our South San Francisco location is between $170,000- $230,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristic.