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.

This is an onsite position, located in Waltham, MA. 

 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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