Sr. Director/Head of Analytical Development
East Coast (REMOTE)
Competitive Compensation + excellent bonus/benefits
Duties and Responsibilities:
- Ensure protocols are following company policies, such as ICH, GMP, USP and FDA regulations
- Strong communication, organization, and multitasking skills are needed to lead
- Oversee collaborations & external management activities (CDMOs)
- Will work and manage in-house and outsourced lab activities.
- Focus on multiple compounds within their pipeline (approaching phase III)
- Oversee internal Analytical CMC team (hire, train, and mentor)
Qualifications:
- Have experience in method development (ideally from scratch)
- Experience overseeing outsourced vendors (CROs/CMOs/CTLs/CDMOs)
- Experience coaching and mentoring scientists (highly coveted)
- M.S or Ph.D. in Chemistry or a related scientific field with ideally 15 years of industry experience (flexible)
- Experience authoring CMC sections for NDA. IMPD, & BLA is highly sought after
