ASSOCIATE DIRECTOR OF AOC PROCESS DEVELOPMENT & MANUFACTURING
Company: Confidential
Location: San Diego
Posted on: November 4, 2024
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Job Description:
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
Keywords: Confidential, Laguna Niguel , ASSOCIATE DIRECTOR OF AOC PROCESS DEVELOPMENT & MANUFACTURING, Executive , San Diego, California
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