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.