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 Director of Analytical Sciences and will be responsible for:
- Scientific leadership of conceptualizing, initiating, and execution 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 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 analytical method development, solid state characterization, validation, release, and stability testing activities at CDMOs and in-house.
- Independently conceptualize, design, and conduct experiments; interpret and present data and conclusions to various audiences, including manager, senior leadership. Expected to solve challenging problems by application of one or more (traditional or emerging) analytical techniques. Maintain timely and accurate lab records consistent with good documentation practices and work in compliance with all applicable laboratory, safety, quality, and regulatory guidance and requirements.
- Prepare presentation materials and clearly communicate research results to manager, and at internal/external meetings.
- Oversight 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.
- 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.
- Work cross-functionally with Regulatory, Quality, 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 clinical and preclinical colleagues including developability assessment, 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 project management; budget planning, oversight in partnership with quality, regulatory, clinical, and preclinical departments. Periodic organization, documentation of progress and accruals, and contract/PO/invoice coordination with finance.
- Drive and maintain the establishment of internal state-of-the-art analytical capabilities to support discovery, process chemistry, pre-formulation and formulation development under tight timelines and material constraints, to enable accelerated CMC development timelines.
- Ph.D. in analytical chemistry or relevant field with 10+ years of relevant hands-on pharmaceutical/biotech industry experience, or equivalent, in the field of new drug discovery and development.
- Demonstrated problem-solving skills, scientific curiosity, passion, critical thinking, and ability to quickly adapt and shift focus as needed.
- Demonstrated ability to take initiative, ownership, problem identification, problem solving and strategic input. A proven record of sustained laboratory achievement and innovation.
- Extensive hands-on experience and mechanistic understanding of analytical technologies including UHPLC, GC, LC-MS, GC-MS, SFC, dissolution, disintegration, wet chemistry, DSC, TGA, PSD, XRPD, spectroscopic and compendial methods.
- 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 product specifications, method validation protocol/ reports, analytical methods, development reports, release, and stability.
- Experience in late-stage pharmaceutical and analytical chemistry drug development, such as assembling data and authoring, an NDA for a small molecule commercial product is highly preferred.
- Working understanding of all ICH and regulatory guidances. A strong attention to detail and demonstrated prior experience working in lab, GLP, and cGMP environment.
- Scientific excellence as demonstrated by publications, presentations, and/or engagement in the scientific/professional community.
The anticipated salary range for candidates who will work in our South San Francisco location is between $165,000- $224,000. 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.