Senior Director, CMC Technical Operations

Job Overview

Lead CMC strategy for siRNA programs aligning manufacturing plans with timelines. Drive scale-up and tech transfer of oligonucleotide DP processes (HPLC, TFF) under GMP.

Responsibilities

• Advance DP development with formulation and LNP encapsulation; risk assessments.
• Oversee CDMOs, lead campaigns, manage deviations, ensure quality and regulatory alignment.
• Integrate AI-enabled data analysis and digital tools into CMC to accelerate timelines.

Requirements & Qualifications

• BS/MS/PhD in Chemical Engineering, Biochemistry, or Pharmaceutical Sciences.
• 12+ years in CMC development in biotech with siRNA/oligonucleotide RNA therapeutics.
• Expertise in oligonucleotide drug substance manufacturing, scale-up, GMP transfer.
• Experience overseeing CDMO partnerships and external manufacturing in clinical-stage programs.
• Strong knowledge of global regulatory expectations for CMC documentation and IND/early programs.