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Associate Director, Formulation and Drug Delivery - South San Francisco, United States - Astrix Inc
Description
Our client is a clinical stage biopharmaceutical company dedicated to improving patients' lives. They develop multiple precision medicines targeting hallmark cancer resistance mechanisms.Title:
Associate Director, Formulation and Drug Delivery
Location:
South San Francisco, California
Salary:
$175k - 215k
Position Summary:
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).
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.
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.
Authoring CMC sections of regulatory filings and participating in regulatory agency interactions.Requirements
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
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