Associate Director, Analytical Services

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.

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; 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

Requirements

BSc degree in a relevant biological science required; MSc, PhD or other post-graduate degree in biochemistry or related science is preferred; 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 development, qualification, validation, transfer, and lifecycle management principles; Thorough understanding of current regulatory requirements and practical experience of analytical testing in support of GMP operations; Ability to manage multiple competing priorities in a fast-paced environment; Strong collaboration skills, with the ability to work effectively across functions and influence decision-making through partnership and engagement; Ability to interface effectively with management and other groups or project teams; Computer processing literacy and experience in statistical analysis; Excellent verbal and written communication skills

Nice to have

MSc, PhD or other post-graduate degree in biochemistry or related science; Experience in a GMP-compliant environment

Benefits

Annual performance incentive bonus; New hire equity; Ongoing performance-based equity; Medical, dental, and vision insurance; 401k match; Flexible time off; Paid holidays including year-end shutdown