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 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.

Business Partnership

• 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.

Requirements

Basic 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 to include:

• 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.

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 proven track record demonstrating issue resolution.

ABILITIES AND JUDGEMENT:

• Ability to 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 message that are easily understood.

• Balances team and individual responsibilities.

• There is ~20% of domestic / international travel associated with this role.

The annual base salary for this position ranges from $160,000 to $180,000. In addition, this position is eligible for an annual performance pay bonus.  Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package.  Additional details can be found on our careers website: www.alkermes.com/careers#working-here  

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About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023). 

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.