Sr. Director/ VP
Drug Product Development/Formulations & Manufacturing
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, BLA, and MAA submissions)
- Experience in drug product, technology transfer, formulation and process characterization, and stability testing
- Will work and manage in-house and external lab activities.
- Lead and overlook the Biologics Drug Product portfolio
- Focus on multiple compounds within their pipeline (Preclinical, Clinical Phases I-III, and Manufacturing)
Qualifications:
- Experience working among CMC leaders such as Regulatory, Analytical, Quality,Manufacturing
- Past experience overseeing outsourced vendors (CROs/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 over 10 years of industry experience