Principal Engineer, Process Development - OSD

Alkermes; Boston (MA); On-site; USD 173,000 - 193,000; Full time

Benefits offered by this job

Competitive benefits

Annual bonus

Career development

Job summary

Join the Alkermes Process Development team as a Principal Engineer, leading late-stage drug product process development at internal and external manufacturing sites. You will guide small molecule PD, scale-up and tech transfer from Phase 3 to PPQ, working with the CMC team and Operations in a collaborative matrix environment.

The role requires PhD or MS with extensive PD experience, DOE, data analysis, and strong communication. Competitive base salary in a global biopharma setting with benefits.

Qualifications

• PhD (>8 years’ experience) or MS (>15 years’ experience) in Science or Engineering.
• Expertise 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.
• 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 processing techniques such as powder blending, granulation, compression, encapsulation, Wurster coating and pan coating.
• Demonstrated ability to work in a fast-paced matrix environment as well as independently manage priorities and timelines.

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.

Skills

Small molecule PD

Design of experiments

Technical transfer

CDMO management

Process characterization

Regulatory knowledge (ICH/FDA)

Leadership in matrix environments

Communication skills

Education

PhD in Science or Engineering

MS in Science or Engineering

Job description

Job Description

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.

Qualifications

• 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.

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

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.