Associate Director of AOC Process Development & Manufacturing (Indianapolis)

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 filings, leading tech transfer activities, and managing a team to meet the demands of the advancing pipeline.

Applicants for this role at the company should hold a minimum of a Bachelor's degree in a relevant field, with a Master's or PhD preferred, and have at least 8 years of experience in the pharmaceutical industry, specifically in oligonucleotide synthesis and purification at a large scale. The ideal candidate will have a proven track record in process development, manufacturing, and technology transfer, as well as experience with IND and BLA filings. Strong communication, interpersonal skills, and the ability to work effectively in a fast-paced environment are required. The role demands a leader who can identify and mitigate risks, ensure compliance with regulations, and foster collaboration both internally and with external partners.

Travel Percent

Less than 10%

Functions

• Product Management
• Medical Care / Hospital Administration