Temp-Process Development Technician-OSD

Job Description

The Process Development Technician supports the execution of experimental and clinical studies to develop well-understood, robust oral solid dosage (OSD) manufacturing processes. Key responsibilities include execution of experiments, documentation and data collection to support process development. This role plays a key part in maintaining GMP standards and supporting the manufacture of development and clinical supplies.

• Assist in designing experimental programs and compiling data from studies.
• Execute experiments to enhance process understanding and manufacture GMP clinical batches at various scales.
• Complete all documentation accurately and legibly, ensuring compliance, and participate in updating batch paperwork and SOPs.
• Maintain a working knowledge of Manufacturing, Quality, and Development systems and procedures; support regulatory inspections and audits as required.
• Maintain awareness of project schedules and strive to achieve while responding positively and flexibly to changing priorities to ensure desired outcomes.
• Assist with root cause investigations and the implementation of CAPAs, as appropriate.
• Ensure compliance with all applicable cGMP, safety, environmental regulations, and company policies.
• Take ownership of the general upkeep of process areas and ensure project goals are met.
• Perform other duties as assigned.

• Associate or bachelor’s degree in engineering/scientific discipline, or equivalent, with 1-3+ years of experience in pharmaceutical solid oral dosage processing.
• Strong understanding of mechanical and chemical engineering principles as applied to general process systems and oral solid dosage equipment.
• Proficiency with solid oral dosage processing techniques, including powder blending, granulation, compression, coating, and encapsulation.
• Working knowledge of data analysis techniques used in process development studies.
• Technical problem-solving ability utilizing current research and technologies.
• Understanding of the drug development process and the role and impact of process development within this process.
• Demonstrated strong people skills, and excellent verbal and written communication skills.
• Understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development.

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.