Principal Engineer

Join the Alkermes Process Development team as a Principal Engineer, where you will lead late-stage drug product Process Development activities at internal and external manufacturing sites. You will be responsible for providing technical guidance and driving execution for small molecule process development, scale-up and technical transfer to manufacturing from Phase 3 up to PPQ. You will play a key role in the CMC team and work closely with the Operations organization.

This role will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs.

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 Bio Pharma 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.

• PhD (>8 years’ experience) or MS (>15 years’ experience) in Science or Engineering
• Expertise and demonstrated experience in small molecule process development, scale up and technical transfer.
• Expertise in design of experiments, data analysis and data interpretation for process development studies.
• Experience managing contract drug development (CDMO) activities.
• Technical problem-solving ability utilizing current research and technologies.
• Broad understanding of the drug development process and the role and impact of process development within this process
• Demonstrated collaborative leadership, strong people skills, and excellent verbal and written communication skills.
• Expert understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development.
• Subject matter proficiency across a range of processing techniques such as, powder blending granulation, compression, encapsulation, Wurster coating and pan coating.
• Demonstrated ability to work successfully in a fast-paced team/matrix environment as well as independently manage priorities and maintain timelines for multiple activities.
• Previous experience with Process Analytical Technology is preferred.

Travel demands will vary based on project stage and business needs; however, travel will be a key component of this role. The successful candidate is expected to serve as a primary technical…