Sr. Process Development Engineer

Senior Engineer

Join the Alkermes Process Development team as Senior Engineer, where you will provide technical leadership and support the development of innovative small molecule pharmaceutical dosage forms. You will operate within cross functional teams to ensure alignment during drug product development, join the CMC teams, and provide leadership for development teams. You will design and execute experimental studies to develop well understood, robust oral solid dosage manufacturing processes.

Key duties are process design, equipment set-up, troubleshooting equipment, running experiments, collecting/evaluating data to identify and implement process/equipment improvements reducing waste and increasing process reliability. This position requires experience in oral solid dosage processing techniques used for manufacture of dosage forms (such as milling, blending, wet and dry granulation, compression, encapsulation and coating). You will also lead process development activities and clinical manufacturing in a GMP facility for oral solid dosage forms, maintaining GMP standards.

• Act as a subject matter expert in oral solid dosage processing, quickly adopt new technologies, and provide technical guidance, training, and direction to teams.
• Lead lab-scale process development and ensure effective knowledge transfer to pilot-scale manufacturing through reports, presentations, and technical collaboration.
• Design and execute experiments to deepen process knowledge, optimize performance, and improve product robustness.
• Support the operation of a GMP clinical manufacturing facility, enabling diverse processing capabilities and supporting early-stage development activities.
• Oversee batch manufacturing activities, ensuring adherence to safety, quality, and documentation standards while producing GMP batches at multiple scales.
• Responsible for the creation of batch records, change controls and standard operating procedures for area of responsibility with a strong focus on efficiency and continuous improvement.
• Author CMC sections for IND, NDA, and other regulatory filings.
• Develop process trains and flows, ensuring scientifically driven, scalable, and reproducible processes with well-defined critical parameters.
• Maintaining compliance with all aspects of cGMP, safety and environmental legislation and company policies.
• Present technical data to stakeholders, communicate risks and solutions, and collaborate with formulators, engineers, safety, and quality teams.
• Mentor and train junior staff.

• Ph.D. and 3+ years in engineering/scientific discipline; M.S. and 10+ years of related experience; B.S. and 15+ years of related experience in pharmaceutical solid oral dosage processing
• Subject matter proficiency across a range of processing techniques such as, powder blending, encapsulation, granulation, compression, and 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.
• Demonstrated collaborative leadership, strong people skills, and excellent verbal and written communication skills.
• Demonstrated experience in small molecule process development, scale up and technical transfer.

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week.

This role is not eligible for fully remote work.

The annual base salary for this position ranges from $140,000 to $154,000. 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.

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…