Associate Director of AOC Process Development & Manufacturing About the Company Top-tier biopharmaceutical company
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 bioconjugation.
This senior leadership role is pivotal in managing all aspects of AOC drug substance process development and manufacturing, from the early stages to Phase 3 and commercial scale-up.
The successful candidate will be responsible for the technical aspects of AOC DS CMO process development, providing expert guidance, and ensuring the execution of late-stage manufacturing strategies.
A strong background in bioconjugation chemistry, purification techniques, and analytical methods is essential, as is a deep understanding of cGMP and FDA/EMA guidelines.
The role also involves authoring and reviewing regulatory filings, leading tech transfer activities, and working closely with CMOs, QA, and the supply chain to meet the demands of the advancing pipeline.
Applicants for the Associate Director position must have a minimum of a Bachelor's degree in a relevant field, with a Master's or PhD preferred, and at least 8 years of experience in the pharmaceutical industry, particularly in antibody/protein bioconjugation.
Expertise in process development, scale-up, and technology transfer is required, along with a proven track record in late-stage clinical and commercial manufacturing.
The role demands excellent communication, interpersonal skills, and the ability to manage multiple tasks in a fast-paced environment.
The ideal candidate will have experience with IND and BLA filings, a strong understanding of global regulatory requirements, and a history of effective collaboration with both internal teams and external partners.
Travel Percent
Less than 10%
Functions Product ManagementMedical Care/Hospital AdministrationInformation Technology