Job Description

Job Title

Senior IT, Technical Services Specialist

Location

Waltham, MA (Hybrid Office Schedule)

Position Summary

The Senior IT, Technical Services Specialist supports technology implementation, system maintenance, and production operations to ensure reliable, secure, and compliant performance of GMP and GxP systems. This role contributes to the development and execution of SOPs aligned with GMP guidelines, assists with onboarding and validating new equipment, and helps maintain the compliance and lifecycle management of existing systems. This position plays a key role in implementing new IT GxP solutions such as Data Historian and LIMS, by technically leading, performing system configuration, testing, documentation, and user support activities. Working closely with CMC, quality, and regulatory teams, the analyst ensures that system operations align with FDA and global regulatory expectations while supporting continuous improvement and operational excellence. Success in this role requires strong technical expertise in pharmaceutical manufacturing systems, a solid understanding of regulatory compliance requirements, and the ability to troubleshoot, integrate, and support complex IT solutions within a GMP environment.

Responsibilities

Responsibilities

• Support Clinical Manufacturing change control, deviation management, and CAPA processes by ensuring IT systems are properly configured, documented, and aligned with regulatory and quality expectations. Demonstrate proficiency with quality and compliance platforms such as Veeva Vault and TrackWise Digital to execute system updates, maintain data integrity, and contribute to compliant operations.
• Define and manage a support and operating model for the Clinical Manufacturing Suite, maintaining application production environments to quality standards and delivering high-value implementation projects on time and on budget.
• Lead and execute implementation and support activities, ensuring SLA adherence and customer satisfaction.
• Collaborate closely with the Process Automation (PA) group to help define and document clear roles and responsibilities between IT and PA, supporting effective coordination, smooth handoffs, and well-established system ownership across both functions.
• Support interactions with external partners and vendors by coordinating technical activities, monitoring service delivery, and ensuring that provided services meet required quality, performance, and regulatory standards.
• Develop, write, and enforce Standard Operating Procedures (SOPs) to ensure adherence to GMP guidelines across all IT-supported manufacturing processes.
• Support onboarding of new equipment into the Clinical Manufacturing Suite, ensuring systems are validated, compliant, and maintained according to regulatory standards.
• Maintain compliance of all existing equipment and IT systems, ensuring continuous alignment with GMP and GxP requirements.
• Support the implementation of new IT GxP systems within the suite (e.g., Data Historian, MES, LIMS) by performing system configuration, validation activities, integration support, and ongoing technical maintenance to ensure compliant and reliable operation.
• Ensure adherence to regulatory requirements (FDA, GxP), cybersecurity standards, and departmental policies, practices, and SOPs.
• Partner with global and local IT management to align best practices across Alkermes, introducing process improvements and leveraging industry learnings.

Qualifications

Qualifications

Basic Qualifications

• Bachelor's degree in computer science, Information Systems, Engineering, or related field.
• Minimum of two (2) years' IT experience supporting pharmaceutical manufacturing suite or with at least 3 years in technical leadership roles.
• Proven experience working with IT vendors and service providers in a regulated environment, including coordinating technical activities, monitoring service quality, and ensuring delivered services meet compliance and performance expectations.
• Demonstrated expertise in GMP and GxP compliance, including authoring and maintaining SOPs for IT systems that support manufacturing operations, and ensuring system activities are documented and executed in alignment with regulatory expectations.
• Strong background in equipment onboarding, validation, and lifecycle management to ensure systems remain compliant and audit-ready.

Preferred Qualifications

• Hands-on experience with ERP, Data Historian, Laboratory Information Management Systems (LIMS), and other GxP manufacturing support technologies.
• Strong understanding of system validation, qualification, and change control processes within pharmaceutical or biotech environments, with the ability to apply these practices to ensure compliant implementation and maintenance of IT systems.
• Excellent verbal and written communication and presentation skills, with the ability to interact professionally with managers, and subject matter experts.
• Self-starter with ability to multitask and manage simultaneous work requests across departments and cross-functional teams.

Competencies

• Demonstrated hands-on problem-solving skills for supporting and troubleshooting manufacturing IT systems.
• Strong collaboration across IT, manufacturing, and quality functions.
• Capable of managing multiple technical priorities in a fast-paced, regulated environment.
• Consistent commitment to compliance, quality, and operational excellence.

The annual base salary for this position ranges from $131,000 to $157,000. 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

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.