Associate Director, Formulation and Drug Delivery - South San Francisco, 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. Our culture and values support our mission, provide a shared understanding of how we work together as a company and provide a clear sense of what is most important for us as an organization. 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 beresponsible for:

Responsibilities:

• 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.
• 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.
• 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 candidates.

Qualifications :

• Ph.D. or M.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.
• Strong understanding and extensive hands‐on experience in early- and late-stage drug product process development. In-depth understanding of formulation development best practices & trends.
• Proven experience in the generation of relevant regulatory sections of IND filings.
• Excellent problem-solving and decision-making skills with the ability to quickly adapt to changing program needs

The anticipated salary range for candidates who will work in our South San Francisco location is between $160,000- $215,000. 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.
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