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Process Development Manager
2 months ago
We are seeking a highly experienced Process Development Manager to join our team at Alkermes, Inc. in Waltham, MA. The successful candidate will be responsible for managing the pilot scale process development facility and personnel, providing technical guidance for small molecule process development, scale-up, and technical transfer of developed processes to manufacturing.
Key Responsibilities- Process Development and Scale-Up: Design and lead the selection of process trains and process flows, and design and execute experiments to enhance process understanding and manufacture GMP batches at various scales.
- Technical Expertise: Provide Subject Matter Expert understanding of the operation of processing equipment, with the ability to assimilate and use new technologies quickly, and provide guidance, training, and direction on technical items.
- Process Development Activities: Design and lead process development activities focused on developing well-understood, science-driven products and processes at all scales, resulting in robust and repeatable control.
- Process Development and Technology Transfer: Manage a systematic approach to Process Development and Technology Transfer activities to ensure consistency in, and quality of end processes developed.
- Regulatory Compliance: Maintain compliance with all aspects of cGMP, Safety, and Environmental legislation and Company policy, which impacts on day-to-day activities.
- Communication and Leadership: Present technical data to cross-functional teams and senior management as a process development expert, and effectively communicate critical process issues and solutions.
- Team Management: Manage, train, and mentor junior Process Development staff.
- Education: Bachelor's Degree in engineering/scientific discipline, or the equivalent, with 10+ years of experience in pharmaceutical solid oral dosage processing.
- Experience: Subject matter proficiency across a range of processing techniques, such as powder blending, granulation, compression, and coating.
- Expertise: Expertise and demonstrated experience in small molecule process development, scale-up, and technical transfer, as well as design of experiments, data analysis, and data interpretation for process development studies.
- Leadership and Communication: Demonstrated collaborative leadership, strong people skills, and excellent verbal and written communication skills.
- Regulatory Knowledge: Expert understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development.
