Sr. Director of CMC
Greater San Diego Area
Competitive Compensation + excellent bonus/benefits
Duties and Responsibilities:
- Overlook DS & DP for late stage programs & manufacturing
- Ensure protocols follow company compliances, such as cGMP, USP and FDA regulations
- Leads external process development in developing scalable processes with improved product yield and reduced costs for manufacturing systems as well as guiding tech transfer, process and method development, optimization, qualification, and validation activities.
- Will work and manage in-house and outsourced lab activities.
- Focus on multiple compounds within their pipeline (Late Stage Development & Manufacturing)
Qualifications:
- Experience working amongst CMC leaders such as Regulatory, Manufacturing and Quality
- Past experience overseeing outsourced vendors (CROs/CMOs/CTLs/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, IMPD, NDA and MAA is highly sought after
