Position Summary:

The Associate Director position leads Process Development activities at our Wilmington facility, providing technical guidance for small molecule process development, scale-up and technical transfer to manufacturing. The position based in Wilmington reports to the Pharmaceutical Development function based in the Waltham Boston facility and plays a key role in collaboration between the two sites and  Development and Commercial Operations. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs.

Responsibilities:

• Provide subject matter expertise in process development methodologies at Alkermes requiring internal 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.

Qualifications and Requirements:

• 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 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, 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.
• Previous experience with Process Analytical Technology and drug product formulation is preferred.

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