Director, Regulated Bioanalytics, Sample Management
Merck
13 days ago
On-site
Lower Gwynedd, PA
Operations
Role Overview
Director, Global Regulated Bioanalytics Sample Management (West Point, PA; Springhouse, PA; Schwabenheim, Germany global oversight). Lead end-to-end sample management for regulated bioanalytical studies, enabling receipt, handling, and distribution of clinical samples and reagents.
Key Leadership Expectations
- Lead through empowerment; foster trust, ownership, continuous learning.
- Recruit, develop, retain talent; coach and mentor future leaders.
- Influence across functions/geographies (Clinical Operations, IT, Quality, global stakeholders).
- Translate priorities into clear strategic objectives.
- Champion innovation and continuous improvement.
Core Responsibilities
- Lead global sample management operations and ensure consistent, high-quality execution.
- Lead teams for receipt, processing, aliquoting, storage, and distribution (efficiency, compliance, scalability).
- Partner with Clinical Operations to improve processes from collection through reporting.
- Oversee evaluation/implementation/optimization of LIMS and automation; partner with IT for integrations.
- Represent the function in internal/external audits; ensure inspection readiness and quality.
- Act as SME on sample management technologies and industry trends.
- Set priorities and performance metrics; ensure SOPs/job aids/processes are current and GxP-compliant.
Education & Experience
- B.A./B.S. (15+ yrs), M.S. (10+ yrs), or Ph.D. (8+ yrs) in relevant sciences/engineering; or equivalent regulated lab/automation/global sample management leadership. Supply Chain/Logistics preferred.
Required Experience/Skills
- GxP-regulated team leadership (empowerment, accountability, development).
- Lead through influence in complex/matrixed global environments.
- Lab automation experience (e.g., liquid handlers/robotics/automated storage).
- LIMS implementation/enhancement.
- Strong communication; strategic and operational execution; continuous improvement.
- Trust-based relationships with senior leaders; collaboration/inclusion.
Required/Selected Skills
ADME, Automation, Bioanalysis, Laboratory Automation, Continuous Process Improvement, Operational Resilience, Immunoassays/Immunochemistry, Pharmacokinetics.
Benefits/Compensation
- Salary range: $173,200.00–$272,600.00. Eligible for annual bonus and long-term incentive (if applicable). Comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays, vacation, compassionate and sick days).
Application Instructions
Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting (job posting end date: 06/10/2026; effective until 11:59:59PM the day before). Requisition ID: R398892.
Director, Global Regulated Bioanalytics Sample Management (West Point, PA; Springhouse, PA; Schwabenheim, Germany global oversight). Lead end-to-end sample management for regulated bioanalytical studies, enabling receipt, handling, and distribution of clinical samples and reagents.
Key Leadership Expectations
- Lead through empowerment; foster trust, ownership, continuous learning.
- Recruit, develop, retain talent; coach and mentor future leaders.
- Influence across functions/geographies (Clinical Operations, IT, Quality, global stakeholders).
- Translate priorities into clear strategic objectives.
- Champion innovation and continuous improvement.
Core Responsibilities
- Lead global sample management operations and ensure consistent, high-quality execution.
- Lead teams for receipt, processing, aliquoting, storage, and distribution (efficiency, compliance, scalability).
- Partner with Clinical Operations to improve processes from collection through reporting.
- Oversee evaluation/implementation/optimization of LIMS and automation; partner with IT for integrations.
- Represent the function in internal/external audits; ensure inspection readiness and quality.
- Act as SME on sample management technologies and industry trends.
- Set priorities and performance metrics; ensure SOPs/job aids/processes are current and GxP-compliant.
Education & Experience
- B.A./B.S. (15+ yrs), M.S. (10+ yrs), or Ph.D. (8+ yrs) in relevant sciences/engineering; or equivalent regulated lab/automation/global sample management leadership. Supply Chain/Logistics preferred.
Required Experience/Skills
- GxP-regulated team leadership (empowerment, accountability, development).
- Lead through influence in complex/matrixed global environments.
- Lab automation experience (e.g., liquid handlers/robotics/automated storage).
- LIMS implementation/enhancement.
- Strong communication; strategic and operational execution; continuous improvement.
- Trust-based relationships with senior leaders; collaboration/inclusion.
Required/Selected Skills
ADME, Automation, Bioanalysis, Laboratory Automation, Continuous Process Improvement, Operational Resilience, Immunoassays/Immunochemistry, Pharmacokinetics.
Benefits/Compensation
- Salary range: $173,200.00–$272,600.00. Eligible for annual bonus and long-term incentive (if applicable). Comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays, vacation, compassionate and sick days).
Application Instructions
Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting (job posting end date: 06/10/2026; effective until 11:59:59PM the day before). Requisition ID: R398892.