Associate Director, External Operations API

Overview

Associate Director, External Operations API — API process expert responsible as the technical lead representative supporting API manufacturing at Contract Manufacturing Organizations (CMOs) 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 CMOs on behalf of Alkermes.

• 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 control strategy documentation through the commercial part of the lifecycle of the API.
• Provide technical input into the commercial master batch records.
• Provide input into the Specification and Commercial Purchasing Specification.
• Provide technical input into Process FMEA and Change Risk assessments.
• Provide technical review of regulatory filings supporting CMC aspects of regulatory dossiers, providing input and guidance around the manufacturing control strategy prior to filing and process validation.
• Support validation planning and execution of APIs as needed as part of cross functional teams involving Supply Chain, Quality and Validation.
• Work closely with the Process Development providing that link between Development and Commercial manufacturing throughout the product lifecycle. Provide commercial technical requirements for all molecules transitioning from Development to Commercial. Would be required to provide input and guidance to the manufacturing decision making processes prior to filing and validation.
• Support Alkermes CMOs in regulatory and external auditor inspections and respond to observations as needed.
• Support the Operations leadership with the project management and implementation of key technical projects which are identified as part of the company’s objectives in both CMOs and Alkermes facilities.
• Manage, coach and develop direct reports ensuring that they deliver and reach their potential.

• Establish and maintain strong working relationships to build partnerships based on trust with CMOs.
• Develop recommendations for strategic/business decisions. Provide management with accurate and timely information necessary to make strategic, investment and operating decisions.
• Preparation of CMO competency assessment to ensure robust decision-making processes when it comes to vendor selection and vendor optimization discussions with senior management.
• Facilitate the transfer of new products and development projects to site’s through the development of effective business cases and management support.
• Preparation of credible and reliable business plans, budgets, and forecasts.
• Foster and promote internal collaboration.
• Ensure support and integration of Technical Operations with relevant functions to achieve customer service objectives.

• Bachelor’s degree in…