Director of Process Development Engineering

2542 Director of Process Development Engineering This position is responsible for leading and empowering the Development Team in taking Company's' drug product candidates from formulation development through process development, scale-up, optimization, process characterization, clinical production, and technical transfer to the commercial manufacturing site. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs. Responsibilities and Requirements: Lead process development strategy for Company's' products and ensure processes are suitable for the phase of development and ultimately for commercial manufacturing. This includes process design and development, scale-up and optimization, characterization and control strategy development and technical transfer to internal manufacturing site or CMO/CDMOs Recruit, manage, train, motivate, develop, and mentor Process Development staff. Collaborate closely with colleagues across Pharmaceutical Development and Manufacturing organizations to best leverage internal and/or external capabilities to assist in process development effort. Ensure process development approaches are suitable for progressive stages of small molecule pharmaceutical development as outlined in ICH and FDA guidance. Operation of the Process Development laboratories and GMP clinical manufacturing suites which are currently under development in Waltham, MA. Provide subject matter expertise in process development methodologies at Company's' requiring internal execution and technical oversight/supervision. Present technical data to cross functional teams and senior management as a process development expert and effectively communicate critical process issues and solutions. Guide and drive process development, design of experiments, product characterization and control strategy development. Develop, review, and approve process development source documents, and author and review drug product process development sections for regulatory submissions. Ensure the team stays up to date with current technologies and manufacturing trends focusing on continuous improvement and operational excellence. Managing the team budget and supporting the planning of capital requirements for the future Support the Regulatory group in responding to agency questions. Support process validation and commercial launch Provide technical support to internal manufacturing sites and CMOs. Qualifications and Requirements: PhD or MS in Science or Engineering 15+ years technical and leadership experience in pharmaceutical development. This should include experience in Process Development, scaleup and GMP manufacturing with an established history of successfully developing and commercializing products and processes. Expertise and demonstrated experience in small molecule(primarily oral solid dose) process development, scale up, control strategy development and technical transfer.