Job Description

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 i...

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