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- Leading the cGMP drug product manufacturing and packaging activities at CMOs and oversight in close partnership with quality.
- Lead late-stage drug product development activities including scale-up, design of experiments (DOEs), risk assessments, and development of the integrated control strategy in partnership with other CMC functional areas, Quality, Regulatory Affairs, and Manufacturing.
- S. in Chemical Engineering or relevant scientific discipline with at least 10 years of experience in formulation and drug product development and track record of progressing assets from INDs to MAAs.
- Proven experience in the generation of relevant regulatory sections of IND filings.
Associate Director, Formulation and Drug Delivery - San Francisco, CA, United States - Oric Pharmaceuticals, Inc.
Description
ORIC is a research-driven company dedicated to discovering and developing novel therapies that can Overcome Resistance In Cancer.Our collaborative, empowering culture gives scientists the authority, responsibility, and support to do cutting-edge work on therapies for treatment-resistant cancers.
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 Director of Formulation and Drug Delivery and will be responsible for:Accountable for the design, development, and characterization of phase appropriate solid oral dose drug product formulations, packaging, and manufacturing processes to successfully support clinical studies.