Associate Director, Analytical Services at Replimune Group in Framingham

Job description

Overview Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. At Replimune, we live by our values: United: We Collaborate for a Common Goal. Audacious: We Are Bold. Dedicated: We Give Our Full Commitment. Candid: We Are Honest With Each Other. People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves. Join us, as we reshape the future. Summary of job description: The Associate Director, Analytical Services provides both strategic and operational leadership for the Analytical Services laboratory while maintaining an active technical role within the function. The position is responsible for ensuring the compliant, timely, and efficient delivery of analytical data to support process development activities, including process and product characterization studies, manufacturing investigations, analytical method investigations, and analytical method lifecycle management. Working within a small team, the Associate Director is expected to maintain a high level of technical expertise through direct laboratory involvement while leading, coaching, and developing team members. The role requires a balance of leadership and hands-on contribution, with approximately 50% of time dedicated to laboratory-based activities, data review, and technical troubleshooting, alongside departmental management, strategic planning, resource planning, and operational oversight responsibilities. Key responsibilities: · Provide scientific leadership for the Analytical Services team. · Act as the technical expert for analytical methodologies and laboratory operations. · Lead the planning and prioritization of analytical testing activities, ensuring effective resource allocation and alignment with departmental and organizational objectives. · Lead analytical troubleshooting activities and support resolution of complex technical challenges. · Support laboratory activities during periods of high workload or resource constraints. · Perform routine analytical testing and data review as required to support departmental deliverables. · Ensure testing is executed according to approved methods, procedures, and quality standards. · Oversee analytical method lifecycle activities including method development, qualification, transfer, troubleshooting, and continuous improvement. · Review, interpret, and approve analytical data and reports. · Collaborate with cross-functional stakeholders to align analytical activities with project timelines. · Drive laboratory efficiency, standardization, and right first-time performance. · Identify opportunities to improve processes, workflows, and utilization of laboratory resources. Other responsibilities · Lead, coach, mentor, and develop Analytical Services personnel, ensuring appropriate training, performance management, and succession planning. · Manage laboratory resources, equipment, and consumables to ensure uninterrupted laboratory operations. · Support budget planning and monitoring for laboratory operations and capital investments. Educational requirements: · BSc degree in a relevant biological science required. · MSc, PhD or other post-graduate degree in biochemistry or related science is preferred. Experience and skill requirements: · Minimum 8 years' experience in analytical sciences, including analytical method development, analytical services or analytical sciences preferably within a GMP-compliant environment. · Experience supporting analytical activities for product development, technology transfer, regulatory submissions, and commercial manufacturing. · Knowledge of analytical method developme