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 :