Sr. Director/ VP
Drug Substance & Process Chemistry
Greater Bay Area
Competitive Compensation + excellent bonus/benefits
Duties and Responsibilities:
- Able to facilitate, analyze and interpret the data from experiment results
- Ensure protocols are in compliance with company policies, such as cGMP, USP and FDA regulations
- Manage and collaborate with external CMO/CDMO partners
- Author, review and strategically impact CMC sections ( IND, NDA and MAA submissions)
- Lead the drug substance, process optimization, and the late-stage development studies
- Lead and overlook the Small-Molecule Portfolio
- Focus on multiple compounds within their pipeline (phases I-III) to commercialization
Qualifications:
- Experience working amongst CMC leaders such as Regulatory, Analytical, and Quality
- Past experience overseeing outsourced vendors (CMOs/CDMOs)
- Experience overlooking multiple drug candidates within the company's pipelines
- M.S or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 5-7 years of industry experience
- Experience authoring CMC sections for IND, NDA,MAA is highly sought after
