What are the responsibilities and job description for the Product Quality Lead position at Alkermes, Inc.?
POSITION SUMMARY:
Provide onsite Quality Assurance (QA) support for the establishment and operation of Phase I/II oral solid dosage (OSD) manufacturing and analytical activities, with primary focus on analytical lifecycle oversight (instrument qualification, method validation, stability, and data review), cleaning validation for manufacturing equipment, and QA support batch manufacturing. Ensure all activities are executed in full compliance with FDA/EU cGMP requirements and internal quality standards, and support batch disposition through robust data review and cross-functional collaboration.
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.
Degree LevelBachelor's Degree
Benefits:
401K Plan, Health Insurance, Maternity & Paternity Leave