Lead Process Development Engineer I/II

Position Summary: 

This position requires extensive experience in solid oral dosage form process development and a strong knowledge and understanding of unit operations such as blending, milling, granulation, roller compaction, tableting, coating and encapsulation. This individual is an independent contributor who leads the oral product process development for Ph1 and Ph2 clinical supplies at the Waltham location or at a contract manufacturing site. This is a high performing individual supporting / leading the tech transfer for Ph3 clinical development to the commercial manufacturing site at Wilmington OH. This is a key member of the process development team supporting the day-to-day operation of the GMP manufacturing process and the suite. This individual interfaces with the cross functional teams such as formulation, quality, regulatory, facilities management and commercial manufacturing.

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

 Responsibilities:

• Design and execute 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. 
• Lead process risk assessments.
• Sound understanding of the operation of processing equipment with ability to set up equipment and run the process independently and / or with help of technician. 
• Required to assimilate and use new technologies quickly and provide guidance, training, and direction on technical items. 
• Manufacture GMP batches at various scales to support phase appropriate clinical supplies.
• Readiness to support the expansion, set up and operation of a new GMP clinical manufacturing suite with a broad range of processing capability and OSD process and new technology approaches.
• Support qualification, calibration and maintenance of new equipment and instruments. 
• Author /review master batch records, protocols and reports. 
• Author CMC sections for IND, NDA, and other regulatory filings. 
• Author /review change controls, SOPS, deviations and associated CAPAs
• Maintain 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 technician or junior process development staff.
• Perform other duties as assigned.

Qualifications and Requirements:

• Bachelor’s Degree with 8+ years or 
• Master’s Degree with 5+ years of experience in engineering/pharmaceutical /scientific discipline, or the equivalent in pharmaceutical product development environment. 
• Thorough understanding of the pharmaceutical solid oral unit operations. Capable of independently planning the experiments, presenting and interpreting the data and statistical data analysis. 
• Prior experience in working in a cross functional team environment is highly preferred. Ability to identify, highlight and communicate the issues and risk to the senior management. Technical problem-solving ability, gap assessment and offer risk mitigation strategies. 
• Excellent presentation, written and communication skills. Prior experience in writing the process development reports, MBRs, protocols and CMC regulatory documents is required. 
• 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. 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,