Associate Director, Analytical Sciences

Summary

Join a dynamic early-stage company working to create selective medicines for cancer patients and contribute to the strategic analytical aspects of drug substance and drug product development and manufacturing activities.

Requirements

• BS or equivalent in chemistry or related discipline with 10-15 years of relevant industry experience
• PhD in chemistry or related discipline with a minimum of 3-5 years of industry experience
• Strong understanding and knowledge of cGMP/ICH regulations and USP Guidelines
• Expertise in late phase small-molecule Drug Substance and Drug Product analytical support of drug development, and commercial and post-approval changes
• Ability to author and review relevant documentation (methods, protocols, reports) as well as regulatory sections
• Technical leadership experience with CROs and CDMOs
• Mastery of current ICH guidelines and related industry guidelines and practices
• Excellent organization and multi-tasking skills

Responsibilities

• Define/refine and execute on analytical strategy for a late-stage development candidate
• Ensure DS and DP method optimization and ICH method validations are consistent with late-phase expectations
• Participate in the strategic definition and justification of late phase-appropriate and commercial SM, Intermediate, DS, and DP specifications
• Participate as needed on investigation teams as the analytical SME
• Author and review analytical-relevant regulatory submission documents
• Author and review relevant change controls and SOPs