Process Development Engineer I

This position designs and executes experimental studies to develop well understood, robust oral solid dosage manufacturing processes. Key duties are process design, equipment set-up, troubleshooting equipment, running experiments, collecting, and evaluating data to identify and implement process/equipment improvements reducing waste and increasing process reliability.

Key role in maintaining GMP standards in the pilot facility and manufacturing clinical supplies.

Responsibilities:

• 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 select process trains and process flows.

• Design and execute experiments to enhance process understanding and manufacture GMP batches at various scales.

• Responsible for the creation of batch records, change controls and standard operating procedures for area of responsibility with a strong focus on efficiency and continuous improvement.

• Design 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.

• Preparation 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 5+years of experience in pharmaceutical solid oral dosage processing.

Preferred Requirements:

• Thorough mechanical and chemical engineering knowledge as it applies to general process systems and equipment, as well as oral solid dosage drug process systems and equipment.

• "Hands-on" ability to install and troubleshoot instrumentation and equipment.

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

• Demonstrated experience in small molecule process development, scale up and technical transfer.

• Knowledge of design of experiments, data analysis and data interpretation for process development studies.

• Technical problem-solving ability utilizing current research and technologies.

• 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.

• 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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