- Job Type: Full-Time
- Function: Life Sciences R&D/Engineering
- Industry: Biotechnology
- Post Date: 11/22/2022
- Website: oricpharma.com
- Company Address: 240 E. Grand Ave 2nd Floor, South San Francisco, CA, 94080
About ORIC PharmaceuticalsORIC 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.
We are seeking an experienced and highly motivated small molecule formulation scientist with a proven record of sustained laboratory achievement and innovation to join our growing Department of Pharmaceutical Sciences (PharmSci/CMC) at ORIC Pharmaceuticals. The successful candidate will report to the head of PharmSci and will be responsible for:
DUTIES AND RESPONSIBILITIES:
- Leading the design, development, and implementation of phase appropriate drug product formulation, packaging, and manufacturing processes to successfully support preclinical and clinical studies, in close collaboration with process chemistry and analytical sciences Incorporation of drug delivery strategies and principles in drug product design.
- Leading the developability assessment of new candidates, preclinical formulation, preformulation, and discovery pharmaceutics studies including API form selection and characterization to nominate a suitable form for development, troubleshooting, and ‘defining the path’ for new drug Managing internal lab and staff to enable these deliverables.
- Leading the non-GMP and cGMP drug product manufacturing and supply activities at CMOs, including CMO selection and oversight in close partnership with quality.
- Authoring CMC sections to be included in regulatory filings and participating/leading due diligence and partnering efforts as needed.
EDUCATION AND EXPERIENCE:
- PhD in pharmaceutics, material science, chemical engineering or a related filed with 10+ years of pharmaceutical/Biotech industry experience.
- Demonstrated in depth understanding of GLP, cGMP, and CMO
- Excellent communication and organization
- Effective at creating strategic plans and implementing
- Outstanding record of innovation with a sustained publication
- Exceptional problem-solving skills and ability to quickly adapt and shift focus as
- Preferably experience putting together and authoring an
- Preferably experience in preformulation and drug delivery strategy design and implementation in preclinical through clinical drug development.