Associate Director of AOC Process Development & Manufacturing

About the Company

Top-tier pharmaceutical firm

Industry
Pharmaceuticals

Type
Privately Held

About the Role

The Company is in search of an Associate Director for AOC Process Development and Manufacturing, with a focus on Oligo-linker. This senior leadership role is pivotal in overseeing all aspects of oligonucleotide process development and manufacturing, from the initial stages to Phase 3 and commercial scale-up. The successful candidate will be responsible for the technical aspects of oligonucleotide CMO process development, providing expert guidance, and ensuring the execution of late-stage manufacturing strategies. A strong background in oligonucleotide synthesis, and purification, and a deep understanding of cGMP, FDA, and EMA guidelines are essential. The role also involves authoring and reviewing regulatory fili...