Sr. Process Development Engineer

About the role

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.

Responsibilities

• 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.
• Create batch records, change controls, and standard operating procedures for area of responsibility with a strong focus on efficiency and continuous improvement.
• Present technical data to stakeholders, communicate risks and solutions, and collaborate with formulators, engineers, safety, and quality teams.
• Mentor and train junior staff.

Qualifications

• 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.

Preferred Requirements

• Knowledge of design of experiments, data analysis and data interpretation for process development studies.
• Strong understanding of the drug development lifecycle and the critical role of process development, including its impact on product quality, scalability, and timelines.
• Demonstrated expertise in mechanical and chemical engineering principles applied to general process systems and equipment, including specialized knowledge of oral solid dosage (OSD) drug manufacturing systems and associated equipment.
• "Hands-on" ability to install and troubleshoot instrumentation and equipment.
• Strong knowledge of process safety and risk assessments.
• Technical problem-solving ability utilizing current research and technologies.
• Understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development.
• Previous experience with Process Analytical Technology and drug product formulation is preferred.