Sr. Process Development 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.

• Knowledge of design of experiments, data analysis and data interpretation for process development studies.
• Solid 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…