Director, Regulated Bioanalytics, Sample Management

Role Overview

• Lead all aspects of global sample management operations, ensuring excellence across West Point (PA), Springhouse (PA), and Schwabenheim (Germany)
• Build strong cross-functional partnerships, particularly with Clinical Operations, to improve end-to-end study execution from clinical sites through bioanalytical data delivery
• Champion innovation, modernization, and continuous improvement in sample management systems, including LIMS and automation platforms, while maintaining the highest standards of compliance and audit readiness
• Lead teams responsible for sample receipt, processing, aliquoting, storage, and distribution, ensuring efficiency, compliance, and scalability
• Develop and sustain strong partnerships with Clinical Operations to improve processes from sample collection through reporting
• Build and develop a high-performing global team through coaching, mentoring, and talent planning
• Oversee the evaluation, implementation, and optimization of LIMS and automation systems supporting sample management
• Partner with IT to ensure effective integration of automation platforms and data systems
• Serve as a key representative during internal and external audits, ensuring inspection readiness and strong quality practices
• Act as a subject matter expert in sample management technologies and industry trends, guiding future capability development
• Establish and monitor priorities and performance metrics aligned with divisional objectives
• Ensure SOPs, job aids, and processes are current, effective, and compliant with GxP requirements.

Requirements

• B.A./B.S. with at least 15 years, M.S. with at least 10 years, or Ph.D. with at least 8 years of relevant experience in Biology, Chemistry, Biochemistry, Engineering, Biotechnology, or related discipline
• Equivalent experience in regulated laboratory operations, automation, or global sample management leadership will also be considered
• Demonstrated success leading teams in a GxP-regulated environment, with a focus on empowerment, accountability, and development of others
• Proven ability to lead through influence across complex, matrixed, and global organizations
• Experience with laboratory automation technologies (e.g., liquid handlers, robotics, automated sample storage systems)
• Strong communication skills with the ability to engage, align, and motivate stakeholders
• Ability to think strategically while ensuring effective operational execution
• Track record of driving continuous improvement and innovation
• Strong organizational and prioritization skills in a complex, multi-site environment
• Demonstrated ability to build trust-based relationships with senior leaders and cross-functional partners
• Commitment to fostering a culture of collaboration, inclusion, and professional growth.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days