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Process Development Manager

2 months ago

Wilmington, Ohio, United States Alkermes Full time
About the Role

We are seeking a highly skilled and experienced Process Development Manager to join our team at Alkermes. As a key member of our Process Development group, you will be responsible for managing activities associated with small molecule oral solid dosage process development, scale-up, and technical transfer to our manufacturing facility.

Key Responsibilities
  • Process Development: Manage the process development activities required to develop, scale up, optimize, and transfer well-understood robust manufacturing processes for solid oral dosage forms.
  • Manufacturing Operations: Operate GMP manufacturing suites with a broad range of processing capability and technology approaches.
  • 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 Design: Design and lead the selection of process trains and process flows.
  • Experimentation: Design and execute experiments to enhance process understanding and manufacture GMP batches at various scales.
  • System Management: Responsible for the creation, management, and control of systems and procedures, including batch records, change controls, and standard operating procedures for the area of responsibility, with a strong focus on efficiency and continuous improvement.
  • Process Development Leadership: 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. Select appropriate parameters for prototype/finished dosage production to ensure product quality and reproducibility are achieved.
  • Process Development and Technology Transfer: Manage a systematic approach to Process Development and Technology Transfer activities to ensure that consistency in, and quality of end processes developed is achieved.
  • Regulatory Compliance: Prepare, review, and approve protocols, reports, and sections of regulatory submissions.
  • Compliance and Safety: 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.
Requirements
  • Education: Bachelor's Degree in engineering/scientific discipline, or the equivalent, with 10+ years of experience in pharmaceutical solid oral dosage processing.
  • Technical Expertise: Subject matter proficiency across a range of processing techniques, such as powder blending, granulation, compression, and coating.
  • Process Development Experience: Expertise and demonstrated experience in small molecule process development, scale-up, and technical transfer.
  • Design of Experiments and Data Analysis: Expertise in design of experiments, data analysis, and data interpretation for process development studies.
  • Technical Problem-Solving: Technical problem-solving ability utilizing current research and technologies.
  • Drug Development Understanding: Broad understanding of the drug development process and the role and impact of process development within this process.
  • 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.
  • Teamwork and Time Management: Demonstrated ability to work successfully in a fast-paced team/matrix environment as well as independently manage priorities and maintain timelines for multiple activities.
  • Preferred Qualifications: Previous experience with Process Analytical Technology and drug product formulation is preferred.