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
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