Sr. Director/ VP
Drug Product Development | Formulations
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
- Author, review and strategically impact CMC sections ( IND and NDA submissions)
- Experience in drug substance technology transfer, formulation and process characterization, and stability testing
- Will work and manage in-house and outsourced lab activities.
- Lead and overlook the small molecule Portfolio
- Focus on multiple compounds within their pipeline (phases I-III)
Qualifications:
- Experience working amongst CMC leaders such as Regulatory, Analytical, Quality, and Supply Chain
- Past experience overseeing outsourced vendors (CROs/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 and NDA is highly sought after
