Associate Director, Process Development
5 days ago
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.
- 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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