Director, Regulated Bioanalytics, Sample Management

Merck Merck · Pharma · PA

Merck is seeking a Director to lead their Regulated Bioanalytics Sample Management function, overseeing global operations, staff, and processes. The role focuses on ensuring seamless receipt, handling, and distribution of clinical samples and reagents for drug development. Key responsibilities include leading teams, building cross-functional partnerships, championing innovation in sample management systems (LIMS, automation), and ensuring compliance with GxP requirements. The position requires strong leadership, strategic thinking, and experience in regulated laboratory operations.

What you'd actually do

  1. Provide overall leadership and strategic direction for global sample management operations, ensuring consistent, high-quality execution across sites
  2. Lead teams responsible for sample receipt, processing, aliquoting, storage, and distribution, ensuring efficiency, compliance, and scalability
  3. Develop and sustain strong partnerships with Clinical Operations to improve processes from sample collection through reporting
  4. Build and develop a high-performing global team through coaching, mentoring, and talent planning
  5. Oversee the evaluation, implementation, and optimization of LIMS and automation systems supporting sample management

Skills

Required

  • 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)
  • Experience implementing and enhancing LIMS or related laboratory 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

Nice to have

  • ADME
  • Automation
  • Bioanalysis
  • Bioanalytical Assays
  • Biopharmaceuticals
  • Biopharmaceutics
  • Biotechnology
  • Clinical Data
  • Continuous Process Improvement
  • Cross-Cultural Awareness
  • Immunoassays
  • Immunochemistry
  • Innovation
  • Laboratory Automation
  • Mentoring Staff
  • Microbiology
  • Operational Resilience
  • Pharmaceutical Analysis
  • Pharmaceutical Biology
  • Pharmacokinetics
  • Results-O

What the JD emphasized

  • GxP-regulated environment
  • global sample management
  • laboratory automation
  • LIMS