Support preventive action, development, engineering, and ongoing manufacturing efforts regarding quality and efficiency.

Responsibilities

• Monitor active manufacturing batches, process trends, and floor activities to ensure safe, compliant, and efficient fill/finish operations.
• Provide real-time technical support and troubleshooting of batch issues, equipment concerns, and process deviations.
• Lead and support continuous improvement initiatives and change control activities.
• Support and/or lead non-routine on-the-floor activities including engineering studies, proof-of-concept runs, equipment testing, and safety improvements.
• Act as a manufacturing liaison with project Planning, Engineering and Technical teams.
• Develop and maintain process monitoring and trending tools; perform periodic review of data to identify opportunities to improve performance and efficiency
• Identify unfavorable trends, investigate root causes, and support the development and implementation of corrective and preventive actions.
• Provides leadership and manufacturing support in investigations, as assigned.
• Support process and equipment risk assessments to identify risks and weaknesses in new and existing fill/finish processes.
• Champion projects as they transition into and through the manufacturing areas and provide regular status updates to Manufacturing management.
• Develop, revise, and implement SOPs and manufacturing documentation in support of new and changed processes.
• Support Management in authoring and revising GMP documentation, including Master Production Records and operational procedures.
• Provide technical and administrative support in the authoring and review of engineering and validation documentation.
• Support Preventive Maintenance activities PM work orders and equipment inspections.

Core Competencies

• Strong knowledge of fill/finish and aseptic manufacturing operations
• Working knowledge of cGMP regulations
• Strong troubleshooting, documentation, and communication skills
• Ability to work cross-functionally in a regulated manufacturing environment

Qualifications

Qualifications

• Experienced manufacturing, process development, or engineering in a pharmaceutical setting

• Needs to have a blend of both technical and operational know-how in a cGMP setting.

• Dependable, well-organized, efficient worker with good communication skills

• Experience supporting investigations, deviations, change controls, and GMP documentation systems preferred.

Basic Requirements

• BS Degree preferred or equivalent experience
• 1-2 years in manufacturing, process development, or engineering in a pharmaceutical setting

Physical Requirements

Ability to support cleanroom and manufacturing floor operations, including prolonged standing and walking, aseptic gowning, use of PPE, and occasional lifting up to 50 lbs. Must be able to operate manufacturing equipment and meet required medical and vision qualifications.

About Us

Why join Team Alkermes?

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.