Director of Analytical Development
Job Summary
Leading analytical development initiatives, the fully remote Director of Analytical Development will oversee drug substance and product programs, manage external partners, and provide technical leadership to accelerate complex pharmaceutical projects through key milestones.
Key responsibilities:
- Lead analytical development activities, including method development, validation, and technology transfer
- Act as the primary analytical and CMC representative on cross-functional project teams
- Manage CROs and contract laboratories to ensure timely execution of analytical objectives
Required qualifications:
- MS degree in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry, or a related field
- 7+ years of experience in pharmaceutical or biotechnology analytical development and CMC activities
- Strong knowledge of analytical techniques such as HPLC and dissolution testing
- Experience managing CROs and influencing cross-functional teams
- Working knowledge of cGMP requirements and FDA regulatory guidelines
Complete Job Description
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