Associate Director, External Operations API

About the role

Job Description Associate Director, External Operations API

Responsibilities

• Review and maintain Alkermes practices & systems in managing contract manufacturers to ensure compliance with cGMP, and other regulatory requirements.
• Understand chemical processes from both scientific and engineering perspectives, demonstrating expertise in API process development and control.
• Trend CMO API processes and identify opportunities for continuous improvement, implementing such improvements to enhance safety, efficiency, and compliance.
• Oversee API production activities across the commercial supply network, including routine production, monitoring/control plans, investigations, change controls, and CAPAs, ensuring robust, efficient, and controlled processes.
• Identify key chemical and physical attributes of API material pertinent to downstream processing in the drug product process, particularly for new processes.
• Ensure processes are well-defined with appropriate identification of Critical Quality Attributes (CQAs) and Process Performance Qualifiers (PPQs), and measure these attributes appropriately.
• Work with Commercial Supply Chain to optimize the network, including vendor selection and technology transfers/validations as required.
• Maintain process control strategy documentation throughout the commercial lifecycle of the API.
• Provide technical input into commercial master batch records, Specifications, and Commercial Purchasing Specifications.
• Contribute to Process FMEA and Change Risk assessments.
• Provide technical review of regulatory filings supporting CMC aspects of regulatory dossiers, guiding the manufacturing control strategy before filing and process validation.
• Support validation planning and execution of APIs as needed, collaborating with Supply Chain, Quality, and Validation teams.
• Bridge the gap between Development and Commercial manufacturing throughout the product lifecycle, providing technical requirements for molecules transitioning from Development to Commercial.
• Collaborate with Alkermes CMOs during regulatory and external auditor inspections, responding to observations as needed.
• Support Operations leadership with project management and implementation of key technical projects in both CMOs and Alkermes facilities.
• Manage, coach, and develop direct reports to ensure they deliver and reach their potential.

Requirements

• Bachelor’s degree in relevant technical/engineering/scientific discipline, preferably multi-disciplinary with a strong technical/scientific orientation.
• 8-12 years’ experience in high volume/manufacturing/relevant environment, likely including pharmaceutical with a minimum of 2 years at senior level.
• Established track record with evidence of excellent project management, problem-solving, collaborative, leadership, and communication skills.
• Process safety in API environment.
• Strong understanding and experience of technical/scientific challenges in production processes across both API and Drug Product (DP) processes, with a proven track record of issue resolution.

Preferred Requirements

• Process safety in API environment.
• Strong understanding and experience of technical/scientific challenges in production processes across both API and Drug Product (DP) processes, with a proven track record of issue resolution.

Abilities and Judgement

• Foster and promote internal collaboration.
• Logical and problem-solving skills.
• High level of customer orientation/understanding.
• Excellent interpersonal skills and self-starter, demonstrating high level of initiative.
• Good two-way communicator with ability to comprehend others and deliver succinct messages easily understood.
• Balances team and individual responsibilities.

Business Partnership

• Establish and maintain strong working relationships to build trust-based partnerships with CMOs.
• Develop recommendations for strategic/business decisions.
• Provide management with accurate and timely information necessary for strategic, investment, and operating decisions.
• Prepare CMO competency assessments 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 sites through the development of effective business cases and management support.
• Prepare 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.

About Us

Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder, and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders. We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier, and recognized as a Best Place to Work in BioPharma by Fortune Magazine. Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service, or any other characteristic protected by local, state, or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.