Associate Director, Drug Product Operations Tracking Code 447-419 Job Description Summary The Drug Product Operations group located in Cambridge, MA, is seeking an individual to provide technical and operational leadership of drug product development, commercialization, and on-going commercial manufacturing for oral solid dosage forms for small potent molecules. Proactive and effective coordination and collaboration by the Associate Director, Drug Product Operations, with business partners, contract development manufacturing organizations (CDMOs), suppliers, and internal ARIAD team members will ensure production requirements and project timelines are met. The Associate Director, Drug Product Operations will develop and implement operating procedures and metrics to measure and improve efficiency and effectiveness of ARIAD’s operations; and ensure team members and partners remain aligned on all drug product goals/plans. The ideal candidate will have superior communication skills facilitating and leading cross-functional communication among program/project stakeholders. The qualified person shall contribute to and support QbD approaches to product life cycle management programs. Duties and Responsibilities Direct drug product development, process development, process scale-up and technology transfer activities with CDMOs Lead oral solid dosage form manufacturing with CDMOs, suppliers, partners, and internal ARIAD teams to ensure supplies are available as planned to meet global clinical and commercial demand requirements Develop and maintain manufacturing and shipping schedules in coordination with CDMOs and the ARIAD team Provide technical oversight in resolving formulation, process and manufacturing issues Participate in negotiations and execution of proposals with CDMOs Assist in compiling CMC documentation for regulatory filings Help ensure all external suppliers and internal teams meet GMP and other regulatory requirements and guidelines Develop, communicate and implement contingency plans for unplanned events Help ensure that opportunities and problems are considered from a perspective balanced between technical, business and regulatory requirements Help organize and support process knowledge management for manufacturing processes Lead and demonstrate influence with cross-functional teams, partners, and global vendors/suppliers Analyze and translate data into actionable recommendations for improvement of processes Serve as a team leader of a development team, coordinating activities between cross-functional groups, which include commercial API, commercial drug product, analytical development, regulatory CMC, and quality. Drive technical and operational innovation throughout the organization. Foster a culture of high performance, empowerment, collaboration, learning, and diversity. Other duties and responsibilities as required Requirements M.S in pharmaceutical sciences or chemical engineering with 10 – 12 years of relevant experience Ph. D. in pharmaceutical sciences or chemical engineering with 8 years of relevant experience Experience in drug product development of solid oral dosage form preferably tablets and using Quality by Design approach - process development, technical operations, scale-up and commercial manufacturing Experience with highly potent compounds (oncology experience a plus) Experience leading a pharmaceutical development program or project Experience working effectively with domestic and/or international contract manufacturers and suppliers preferred Understanding of the pharmaceutical/biotech industry and regulatory requirements, and meeting country specific regulatory needs Must have experience working in a GMP environment (manufacturing experience desirable) Experience with IND and NDA filings with accelerated timelines a plus Demonstrated evidence of analytical, planning and execution capability Must think critically and creatively, and be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills. Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results. Excellent communication skills (both oral and written) and collaborative interpersonal skills are required. Must be able to lead and participate in highly effective teams. Proficiency in all aspects of Microsoft applications (Excel, Word, Project, PowerPoint, etc.) Job Location Cambridge, Massachusetts, United States Position Type
Posted on: Mon, 21 Jul 2014 14:51:56 +0000