Senior Director, Analytical Development

About This Role As the Senior Director and Head of Analytical Development for Small Molecules & Antisense Oligonucleotides, you will spearhead the advancement and refinement of analytical methods and control strategies critical to our small molecule and antisense oligonucleotide portfolio. Reporting to the Head of Pharma CMC Development and Regulatory, your leadership will be instrumental from R&D transition through to commercialization. You will offer comprehensive expertise in product characterization, ensuring robust support throughout the product lifecycle and in response to comparability assessments. Your role extends to testing commercial products and establishing an early phase clinical testing team under phase-appropriate GMP controls.  What You’ll DoLead and qualify analytical methods for the small molecule and antisense oligonucleotide portfolio. Ensure processes for documenting and transferring analytical methods to Quality Control and external facilities are in place. Characterize new products to support regulatory submissions and lifecycle comparability. Provide leadership to a scientific team of 20+ individuals, managing workload, productivity, and regulatory compliance. Support clinical to commercial analytical methods, improving productivity, reliability, and managing complex investigations. Drive innovation in analytical method development for small molecules and antisense oligonucleotides. Oversee critical sections of IND and NDA submissions, and respond to health authority inquiries.