Job Description

The Manufacturing Systems and Process Support Specialist supports key manufacturing systems and processes to ensure compliance, efficiency, and readiness for audits, inspections, and manufacturing activities. This role provides operational support for platforms such as SAP, Batch Reporting, OSI PI, Maximo, and TrackWise Digital, while collaborating across departments to maintain documentation, support investigations, and assist with introduction of new products including toxicology and clinical materials. The role ensures systems and documentation are aligned with current Good Manufacturing Practices (GMP) and evolving regulatory expectations.

• Partner with manufacturing personnel to proactively identify and resolve GMP non-compliance issues related to manufacturing systems and processes.
• Author and revise SOPs and GMP documentation in support of new or updated manufacturing processes in collaboration with cross-functional teams.
• Coordinate and expedite the review and approval of GMP documents to meet project and compliance timelines.
• Review executed GMP documentation for accuracy and completeness to support production and batch release.
• Facilitate or support investigations, deviations, and CAPAs, serving as SME or scribe where needed.
• Collaborate with departments such as IT, Automation, Quality, Validation, and Supply Chain to resolve system issues and ensure compliance.
• Support preparation of documents for regulatory submissions, validations, and new product introductions.
• Drive continuous improvement initiatives related to system efficiency, quality, and compliance, utilizing the TrackWise Digital system as applicable for Change Controls and Change Action tasks.
• Maintain up-to-date knowledge of regulatory requirements and internal procedures; ensure documents remain inspection-ready.

Required:

• Proven ability to manage multiple projects and meet deadlines in a dynamic, regulated environment.
• Strong cross-functional collaboration and communication skills.
• Working knowledge of US and EU GMP regulations.
• Sound understanding of pharmaceutical manufacturing operations and documentation.
• Excellent written and verbal communication skills.
• Strong attention to detail with a commitment to quality.
• Self-motivated, organized, and dependable with a results-oriented mindset.

Preferred:

• Experience using project management tools such as GANTT charts, PERT charts, and MS Project.
• Familiarity with SAP, Rockwell Automation, Signavio, Veeva, and TrackWise Digital.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Understanding of 21 CFR Part 11 compliance and electronic records management.

Physical Requirements

• Ability to gown for aseptic cleanroom operations.
• Occasional repetitive motions; frequent walking, standing, lifting, and bending.
• Good eyesight for reading, viewing computer screens, and paying attention to details.
• Ability to speak and hear clearly, as well as communicate effectively.
• Ability to stand for extended periods (up to 7 hours) in steel-toed shoes.

Education & Experience

• Bachelor's Degree in a scientific discipline or equivalent experience.

• Minimum of 3 to 5 years’ experience in pharmaceutical or medical device manufacturing, Quality Assurance, or related GMP-regulated roles.

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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.