An exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development leadership team with responsibility for process development activities within the business, ensuring delivery of robust processes that enable the consistent manufacture of high quality and life changing therapeutics for patients.
This position is responsible for leading and empowering the Process Development Team in taking Alkermes' drug product candidates from formulation development through process development, scale-up, optimization, process characterization, technical transfer, clinical production, validation, and commercial launch. The Team will also work with external development and manufacturing organizations.
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:
Develop and maintain strategic vision and long-range plan for the Process Development function.
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.
Lead process development strategy for Alkermes 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.
Support process validation and commercial launch
Provide technical support to internal manufacturing sites and CMOs.
Author, review and approve technical reports and relevant regulatory submission content.
Support the Regulatory group in responding to agency questions.
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
Basic 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.
Preferred Requirements:
Expertise and demonstrated experience in small molecule process development, scale up, control strategy development and technical transfer.
Expertise in design of experiments, data analysis and data interpretation for process development studies.
Experience managing contract drug development activities.
Technical problem-solving ability utilizing current research and technologies.
Broad understanding of the drug development process and the role and impact of process development within this process
Expert understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development.
Strategic thinking and planning ability.
Demonstrated collaborative leadership, strong people skills, and excellent verbal and written communication skills.
Demonstrated ability to work successfully in a fast-paced team/matrix environment as well as independently manage priorities and maintain timelines for multiple activities.