Senior Associate Director of AOC Process Development & Manufacturing

Senior Associate Director of AOC Process Development & Manufacturing About the Company Join a top-tier pharmaceutical firm that is making significant strides in the industry. Industry Pharmaceuticals Type Privately Held About the Role We are looking for a passionate and experienced individual to fill the role of Senior Associate Director for AOC Process Development and Manufacturing, particularly focusing on Oligo-linker technology. This senior leadership position is crucial in managing all facets of oligonucleotide process development and manufacturing, from initial stages through to Phase 3 and commercial scale-up. The successful candidate will lead the technical aspects of oligonucleotide CMO process development, deliver expert guidance, and ensure that late-stage manufacturing strategies are effectively executed. Applicants should possess a strong background in oligonucleotide synthesis and purification, with a comprehensive understanding of cGMP, FDA, and EMA guidelines. Experience in authoring and reviewing regulatory filings is key, along with expertise in leading tech transfer activities and managing teams to meet the evolving demands of our pipeline. To be considered for this role, candidates must hold a minimum of a Bachelor's degree in a relevant field, with preference given to Master's or PhD holders. A minimum of 8 years of experience in the pharmaceutical industry, specifically in large-scale oligonucleotide synthesis and purification, is required. The ideal candidate should have a proven history in process development, manufacturing, and technology transfer, along with experience with IND and BLA filings. We value strong communication and interpersonal skills, as well as the ability to thrive in a fast-paced environment. The role demands a leader capable of identifying and mitigating risks, ensuring regulatory compliance, and fostering collaboration with both internal teams and external partners. Travel Percent Less than 10% Functions Product Management Medical Care/Hospital Administration Information Technology