Our partner is a global privately held biopharmaceutical company focused on developing and delivering therapeutics to patients with devastating disease and unmet medical needs. The company has an experienced management team, significant funding, and a clear vision of building a global, generational company.
This critical hire built and led CMC teams in multiple programs, as well as identified third-party manufacturers and oversaw external operations through tech transfer, process and method development, optimization, qualification, and validation. They advised on CMC aspects of product approval submissions with regulatory authorities, and represented the company to internal stakeholders, commercial partners and contract manufacturing organizations.
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