Supervisor, Analytical Development

Alkermes; Massachusetts; On-site; USD 131,000 - 142,000; Full time

Job summary

Alkermes is seeking an Analytical Development Supervisor to provide technical and operational leadership for small molecule analytical activities within our Pharmaceutical Development organization. This role coordinates testing across manufacturing, ensuring high-quality data to support process development and manufacturing.

The successful candidate will bring strong scientific expertise, people leadership, and cross-functional collaboration in a GMP environment, driving timely project execution

Qualifications

• MS (>5 years) or BS (>10 years) with related experience in analytical chemistry or quality control.
• Strong understanding of the role of Analytical Development within the drug development process.
• Experience with advanced analytical techniques (HPLC/UHPLC, LC/MS, GC, Dissolution, FTIR, UV/Vis, KF, laser diffraction, etc.).
• Familiarity with operation and troubleshooting of LC instrumentation/software (Waters, Agilent, Gilson, etc).
• Experience in a GMP regulated analytical environment.
• Good understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development.
• Demonstrated supervisory or team leadership, coordination and team development capabilities.
• Ability to prioritize tasks and responsibilities for work assignments to meet project timeline.
• Excellent verbal and written communication skills.

Responsibilities

• Partner with Process Development, Manufacturing, Quality, Regulatory, and Project Management teams to support development programs
• Coordinate with manufacturing team to schedule analytical testing activities and sample prioritization
• Supervise day to day testing to ensure compliance with all applicable procedures and timely completion
• Review and approve analytical data, reports, and documentation
• Author, revise or review SOP’s, analytical protocols, analysis reports, specifications, and controlled forms
• Review and approve electronic laboratory notebooks and data packages
• Oversee laboratory equipment, qualification, maintenance programs, and operational readiness
• Support laboratory safety initiatives and continuous improvement activities.
• Troubleshoot analytical methods and investigate technical issues to ensure timely project execution
• Technical oversight of GMP suite environmental monitoring testing and trending
• Perform other duties as assigned

Education

MS (>5 years) or BS (>10 years) in analytical chemistry or quality control

Job description

Job Description

The Analytical Development Supervisor provides technical and operational leadership for small molecule analytical activities within a growing, dynamic Pharmaceutical Development organization. This role coordinates manufacturing area testing activities, ensuring the delivery of high-quality analytical data to support process development and manufacturing. The position requires strong scientific expertise, people leadership, and cross-functional collaboration in a regulated environment. The successful candidate will thrive in a highly collaborative team environment to ensure the successful development of new drugs.

Responsibilities

• Partner with Process Development, Manufacturing, Quality, Regulatory, and Project Management teams to support development programs
• Coordinate with manufacturing team to schedule analytical testing activities and sample prioritization
• Supervise day to day testing to ensure compliance with all applicable procedures and timely completion
• Review and approve analytical data, reports, and documentation
• Author, revise or review SOP’s, analytical protocols, analysis reports, specifications, and controlled forms
• Review and approve electronic laboratory notebooks and data packages
• Oversee laboratory equipment, qualification, maintenance programs, and operational readiness
• Support laboratory safety initiatives and continuous improvement activities.
• Troubleshoot analytical methods and investigate technical issues to ensure timely project execution
• Technical oversight of GMP suite environmental monitoring testing and trending
• Perform other duties as assigned

Qualifications

Basic Qualifications

• MS (>5 years) or BS (>10 years) with related experience in analytical chemistry or quality control

Preferred Qualifications

• Good understanding of the role of Analytical Development within the drug development process
• Experience with advanced analytical techniques (HPLC/UHPLC, LC/MS, GC, Dissolution, FTIR, UV/Vis, KF, laser diffraction, etc.)
• Strong instrumental background, familiarity with operation and troubleshooting of LC instrumentation/software (Waters, Agilent, Gilson, etc)
• Experience in a GMP regulated analytical environment
• Good understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development
• Demonstrated supervisory or team leadership, coordination and team development capabilities
• Ability to prioritize tasks and responsibilities for work assignments to meet project timeline
• Excellent verbal and written communication skills

The annual base salary for this position ranges from $131,000 to $142,000. 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.