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.
Responsibilities- Provide subject matter expertise in process development methodologies at Alkermes requiring internal/external execution and technical oversight/supervision.
- Guide and drive process development, design of experiments, product characterization and control strategy development for development programs.
- Design and execute process development activities suitable for progressive stages of small molecule pharmaceutical development that follow ICH and FDA guidance.
- Work closely with colleagues across Pharmaceutical Development and Manufacturing organizations to best leverage internal and/or external capabilities to assist in process development effort.
- Provide timely technical support and management oversight of process development activities at external partners.
- Develop, review, and approve process development source documents, and author and review drug product process development sections for regulatory submissions.
- Present technical data to cross functional teams and senior management as a process development expert, and effectively communicate critical process issues and solutions.
- Identify and advocate new and emerging technology opportunities for process development.
- Manage, train and mentor junior Process Development staff.
- Perform other duties as assigned.
- 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 Requirements
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 representative during critical manufacturing activities and provide onsite leadership at development and commercial manufacturing sites during scale-up campaigns, technology transfers, validation activities, process troubleshooting, and other key project milestones as needed.
The annual base salary for this position ranges from $173,000 to $193,000. 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
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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.
Skills Required
- PhD (>8 years) or MS (>15 years) in Science or Engineering
- Expertise in small-molecule process development, scale-up and technical transfer (Phase 3 to PPQ)
- Experience managing contract drug development (CDMO) activities and providing oversight at external partners
- Expertise in design of experiments, data analysis and interpretation for process development
- Ability to develop control strategies, author and review process development documents and regulatory submission sections
- Expert understanding of ICH, FDA, and USP guidelines and ability to apply them to drug development stages
- Subject matter proficiency across processing techniques: powder blending, granulation, compression, encapsulation, Wurster coating and pan coating
- Demonstrated collaborative leadership, people management, mentoring, and strong verbal and written communication skills
- Ability to work in a fast-paced matrix environment and independently manage priorities and timelines for multiple activities
- Previous experience with Process Analytical Technology (PAT)
What We Do
Alkermes focuses on the development of innovative medicines that seek to address unmet needs of people living with serious mental illness, addiction, and cancer. As a fully-integrated, global biopharmaceutical company, we apply our scientific expertise and proprietary technologies to develop products that are designed to make a meaningful difference in the way patients manage their disease. We are inspired by some of the most pressing public health challenges of our time to help advance innovation with the potential to improve treatment options and outcomes for patients. Beyond our important mission of developing medicines, we believe it is our responsibility to take a holistic approach as we seek to support patients, caregivers, and broader impacted communities. In this context we also work to help support and enhance the systems through which these complex diseases are treated. We are committed to patient engagement, disease education and awareness, and advocacy for important policies that support equitable access to quality treatment. Headquartered in Dublin, Ireland, we have an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. See our Community Guidelines: https://www.alkermes.com/social-community-guidelines
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