Process Development Manager

4 weeks ago

Waltham, Massachusetts, United States Alkermes, Inc. Full time

The Process Development Manager manages the pilot scale process development facility and personnel and provides technical guidance for small molecule process development, scale-up and technical transfer of developed processes 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.

Responsibilities:

  • Managing the set up and operation of a new GMP clinical manufacturing suite with a broad range of processing capability and technology approaches.
  • Provide Subject Matter Expert understanding of the operation of processing equipment with ability to assimilate and use new technologies quickly and provide guidance, training, and direction on technical items.
  • Design and lead selection of process trains and process flows.
  • Design and execute experiments to enhance process understanding and manufacture GMP batches at various scales.
  • Responsible for the creation, management and control of systems and procedures including batch records, change controls and standard operating procedures for area of responsibility with a strong focus on efficiency and continuous improvement.
  • 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.
  • Managing a systematic approach to Process Development and Technology Transfer activities to ensure that consistency in, and quality of end processes developed is achieved.
  • Preparation, review, and approval of protocols, reports and sections of regulatory submissions.
  • Maintaining compliance with all aspects of cGMP, Safety and Environmental legislation and Company policy, which impacts on day-to-day activities.
  • Present technical data to cross functional teams and senior management as a process development expert, and effectively communicate critical process issues and solutions.
  • Manage, train and mentor junior Process Development staff.
  • Perform other duties as assigned.

Basic Requirements:

  • Bachelor's Degree in engineering/scientific discipline, or the equivalent with 10+years of experience in pharmaceutical solid oral dosage processing.

Preferred Requirements:

  • Subject matter proficiency across a range of processing techniques such as, powder blending granulation, compression, and coating.
  • 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
  • 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.
  • 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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