Director of Product Development

Position Summary The position is responsible for the project oriented technical leadership for process development and manufacturing of investigational drug products from clinical to commercial stage. Essential Duties and Responsibilities Manage and oversee activities and contractual relationship with Contract Manufacturing Organizations (CMOs) performing process scale-up development, technology transfer, and manufacturing of drug product. Lead and collaborate with cross functional project team members to meet operational, quality, and CMC goals. Write Request for Proposal and negotiate contracts and agreements. Evaluate and select contract manufacturers. Thoroughly review and approve master and executed manufacturing and packaging batch records. Provide manufacturing summary reports. Assist in preparation of regulatory documentation for IND and NDA submissions. Work closely with CMC project managers, CTM supply chain manager, and drug substance team to plan and coordinate manufacturing activities to meet clinical supply projection. Troubleshoot manufacturing related issues. Make decisions and recommendations. Knowledge/Skills/Abilities Required Master’s degree in pharmaceutical sciences, chemistry, chemical engineering or relevant area. 8+ years relevant industry experience with increasing responsibility. Extensive experience with process scale-up and manufacturing of oral solid dosage forms. Prior experience with QbD (Quality by Design) and process validation is a plus. Proven track record of CMO management. Experience in compiling technical information for manufacturing and control of critical steps to support regulatory submissions. Thorough understanding of drug product GMPs and quality systems. Excellent written and oral communication skills. Strong organizational and problem solving skills. #J-18808-Ljbffr