Executive Director/Head of CMC
Small Molecules & Biologics
Greater Boston Area
Competitive Compensation + excellent bonus/benefits
Duties and Responsibilities:
- Overlook DS & DP for Pre-Clinical/Clinical Trials
- Ensure protocols follow company compliances, such as cGMP, USP and FDA regulations
- Author, review and strategically impact CMC sections (Pre-IND, IND & BLA submissions)
- Will work and manage in-house and outsourced lab activities.
- Lead and overlook the Small Molecule & Biologics Portfolio
- Focus on multiple compounds within their pipeline (Early Stage & Late Stage Development)
Qualifications:
- Experience working amongst CMC leaders such as Regulatory, Analytical, 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, BLA and NDA is highly sought after
