Principal Engineer, Process Development - OSD

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.

• 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.

• 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.

Travel Requirements

Travel demands will vary based on project stage and business needs; however, travel will be a key component of this role. The successful candidate is expected to serve as a primary technical representative during critical manufacturing activities and provide onsite leadership at development and commercial manufacturing sites during scale-up campaigns, technology transfers, validation activities, process troubleshooting, and other key project milestones as needed.

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