Associate Director, External Operations API

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Not verified last checked Jun 13, 2026

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401(k) match

Listed Source: EMPLR_CONTRIB_INCOME_AMT. source Last checked Jun 13, 2026.

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About this role

Associate Director, External Operations API Waltham, MA, United States Associate Director, External Operations API API process expert responsible as the technical lead representative supporting API manufacturing at Contract Manufacturing Organizations' (CMO's) and subsequent processing of API's in Drug Product (DP) processes across OSD and injectables. Required to support new product introductions, technology transfers, continually monitor and improve API operations conducted at CMO's on behalf of Alkermes. Responsibilities General Review and maintain Alkermes practices & systems in managing contract manufacturers to ensure compliance with cGMP, and other regulatory requirements - ensuring that appropriate policies, rules, regulations and agreements are followed. Understanding of chemical processes from both scientific and engineering perspective demonstrating expertise in how API processes are developed and controlled to maximize yield and minimize impurities. Perform trending on CMO API processes and identify opportunities for continuous improvement providing technical leadership to implement such improvements to deliver on safety, efficiency and/or compliance. Oversee activities related to API production across the commercial supply network including routine production and associated monitoring/control plans as well as investigations, change controls and CAPA's ensuring processes are robust, efficient and in control. Understand and identify key chemical and physical attributes of API material as it pertains to downstream processing in the drug product process. For new processes ensure that the process is well defined with appropriate identification of CQAs and CPP's with appropriate measurement of both. In conjunction with Commercial Supply Chain oversee network optimization to include vendor selection and technology transfers/validations as required. Maintain the process

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