Associate Director, Operations - GMP

At Bio Agilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . and we are growing. Our culture is fast-paced, fun and never boring.

Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.

Bio Agilytix is seeking an Associate Director to lead GMP laboratory operations at our Raleigh-Durham facility, supporting lot release and stability testing for biologics, gene therapies, cell therapies, and related products. This role leads multiple teams through managers and supervisors and is accountable for scientific quality, operational performance, capacity, and reliable delivery.

The Associate Director will provide technical and operational direction across multiple analytical platforms and support clients and internal scientific teams. The ideal candidate will bring strong GMP laboratory experience, particularly with lot release and stability testing, along with experience supporting external clients or internal stakeholders.

Success in this role requires strong relationship-building skills, sound judgment, and the ability to lead effectively through change. The Associate Director will take ownership of complex projects, establish a clear path forward when information is incomplete, and work independently while engaging the appropriate partners at key decision points.

• Lead managers, supervisors, and scientific teams responsible for GMP laboratory operations, with accountability for performance, quality, capacity, and delivery
• Oversee GMP sample analysis supporting lot release, stability, characterization, and other specification-driven testing
• Provide technical and operational oversight for validated and transferred analytical methods throughout the method lifecycle
• Evaluate assay performance and lead the resolution of complex scientific and operational issues
• Lead or oversee laboratory investigations involving deviations, out-of-specification and out-of-trend results, CAPAs, change controls, root-cause analysis, and effectiveness monitoring
• Review and approve GMP laboratory documentation, which may include raw data, analytical data packages, test methods, protocols, reports, certificates of analysis, and investigation records
• Establish and monitor laboratory, operational, and assay-performance metrics. Identify adverse trends and implement sustainable corrective or preventive actions
• Monitor capacity, throughput, utilization, and backlog and take action to improve performance and delivery
• Standardize workflows, management routines, metrics, and escalation processes across the assigned area
• Resolve cross-functional issues affecting staffing, quality, timelines, and client commitments
• Build effective relationships with clients and internal partners across Operations, Quality Assurance, scientific functions, and other business teams
• Support client audits, regulatory inspections, and the preparation of technical responses
• Develop managers and supervisors, strengthen leadership capability, and support succession planning across the organization
• Contribute to budget planning, headcount planning, audit readiness, and process-improvement initiatives
• Translate departmental goals into operating plans and communicate progress, risks, and mitigation actions to leadership
• Perform other duties as assigned

• Bachelor’s degree in scientific discipline, life sciences, operations, quality, or a related field.
• Eight (8) or more years working in a regulated laboratory, pharmaceutical, biotechnology, CDMO, CRO, bioanalytical, quality, or scientific operations environment
• Six (6) or more years of people leadership
• Technical and operational leadership of GMP sample analysis supporting lot-release, stability, characterization, or other specification-driven testing
• Client support or internal scientific stakeholder management within a regulated environment
• An equivalent combination of directly relevant education, training, and experience may be considered

• Extensive knowledge of GMP…