Senior / Executive Director of Chemistry, Manufacturing, and Controls (CMC)
The Senior / Executive Director of Chemistry, Manufacturing, and Controls (CMC) will serve as the strategic and technical leader managing a small molecule portfolio development from candidate selection through clinical development. Operating within a lean, agile mindset, this executive will manage a robust external network of CDMOs to drive drug substance (DS) synthesis, process chemistry optimization, scale-up, and advanced formulation/drug product (DP) development. The ideal candidate blends deep synthetic organic chemistry and preformulation expertise with the strategic vision required to navigate rapid timelines, risk management and global regulatory frameworks. The candidate will be expected to be a CMC leader possessing strong communication skills
What You Will Do:
Strategic Portfolio Leadership: Establish and execute the global CMC strategy for the small molecule discovery and development pipeline, ensuring seamless transition from lead optimization to IND/CTA enablement.
Drug Substance (DS) Development & Scale-Up: Oversee phase-appropriate process chemistry, route scouting, crystalline form screening/polymorph evaluation, and scale-up strategies for critical active pharmaceutical ingredients (APIs).
