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 work either remotely or hybrid, reporting to the Director of Process Chemistry, and will be responsible for the following;
- 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.
- Proposal and management of outsourced research activities, and 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.
- 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 through coordination of labeling, packing, shipping, and any other needs. 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; follow-ups and keeping activities on track meeting high quality deliverables in a timely manner.
- PhD in organic chemistry with 7-10+ 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.
- 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.
About ORIC Pharmaceuticals:
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s lead product candidate, ORIC-101, is a potent and selective small molecule antagonist of the glucocorticoid receptor, which has been linked to resistance to multiple classes of cancer therapeutics across a variety of solid tumors. ORIC-101 is currently in two separate Phase 1b trials of ORIC-101 in combination with (1) Xtandi (enzalutamide) in metastatic prostate cancer and (2) Abraxane (nab-paclitaxel) in advanced or metastatic solid tumors. ORIC’s other product candidates include (1) ORIC-533, an orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy- and immunotherapy-based treatment regimens, (2) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (3) ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations, being developed across multiple genetically defined cancers. Beyond these four product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to http://oricpharma.com/.