Associate Director Of Aoc Process Development & Manufacturing, Oklahoma City
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Oklahoma City, USA
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Posted: a week ago
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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
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Job positionAssociate Director Of Aoc Process Development & Manufacturing
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