Associate Director, Process Development

3 days ago

Wilmington, Delaware, United States Alkermes Full time
Job Summary

The Associate Director, Process Development role at Alkermes is a critical position that leads Process Development activities at our Wilmington facility. This position provides technical guidance for small molecule process development, scale-up, and technical transfer to manufacturing. 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.

Key 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, following 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 efforts.
  • 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.
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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