Associate Director, Process Development

5 days ago


Wilmington, Ohio, United States Alkermes, Inc. Full time
Job Summary

The Associate Director, Process Development position at Alkermes, Inc. leads process development activities at our Wilmington facility, providing technical guidance for small molecule process development, scale-up, and technical transfer to manufacturing.

Key Responsibilities
  • Provide subject matter expertise in process development methodologies, 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 leverage internal and/or external capabilities for 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, effectively communicating 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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