Director, Regulated Bioanalytics, Sample Management
Merck
13 days ago
On-site
West Point, PA
Operations
Role Overview:
Director leading Global Regulated Bioanalytics Sample Management operations across West Point (PA) and Springhouse (PA), with oversight in Schwabenheim (Germany). Improve end-to-end study execution with Clinical Operations; modernize sample management systems (e.g., LIMS, automation) while ensuring GxP compliance and audit readiness.
Key Responsibilities:
- Provide strategic leadership for global sample management; ensure consistent, high-quality execution across sites.
- Lead teams for sample receipt, processing, aliquoting, storage, and distribution (efficiency, compliance, scalability).
- Partner with Clinical Operations to improve processes from sample collection through reporting.
- Coach and mentor to build and develop a high-performing global team.
- Evaluate, implement, and optimize LIMS and automation systems supporting sample management.
- Partner with IT to integrate automation platforms and data systems.
- Represent the function during internal/external audits; ensure inspection readiness and strong quality practices.
- Serve as SME for sample management technologies and industry trends.
- Establish/monitor priorities and performance metrics; ensure SOPs/job aids are current and GxP-compliant.
Qualifications:
- B.A./B.S. (15+ yrs) or M.S. (10+ yrs) or Ph.D. (8+ yrs) in Biology, Chemistry, Biochemistry, Engineering, Biotechnology, or related; or equivalent regulated lab operations/automation/global sample management leadership. Supply Chain/Logistics preferred.
Required Experience & Skills:
- Proven people leadership in a GxP-regulated environment (empowerment, accountability, development).
- Ability to lead through influence in complex, matrixed, global organizations.
- Lab automation (liquid handlers/robotics/automated storage); LIMS implementation/enhancement.
- Strong strategic execution, communication, prioritization, continuous improvement, and trust-building.
Required Skills (examples):
- Bioanalysis, ADME, automation, laboratory automation, continuous process improvement, mentoring/talent development, operational resilience, pharmacokinetics.
Benefits/Comp:
- Salary range: $173,200.00–$272,600.00; eligible for annual bonus and long-term incentive (if applicable). Comprehensive benefits incl. medical/dental/vision, retirement (401k), paid holidays/vacation, and sick/compassionate days.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.
Director leading Global Regulated Bioanalytics Sample Management operations across West Point (PA) and Springhouse (PA), with oversight in Schwabenheim (Germany). Improve end-to-end study execution with Clinical Operations; modernize sample management systems (e.g., LIMS, automation) while ensuring GxP compliance and audit readiness.
Key Responsibilities:
- Provide strategic leadership for global sample management; ensure consistent, high-quality execution across sites.
- Lead teams for sample receipt, processing, aliquoting, storage, and distribution (efficiency, compliance, scalability).
- Partner with Clinical Operations to improve processes from sample collection through reporting.
- Coach and mentor to build and develop a high-performing global team.
- Evaluate, implement, and optimize LIMS and automation systems supporting sample management.
- Partner with IT to integrate automation platforms and data systems.
- Represent the function during internal/external audits; ensure inspection readiness and strong quality practices.
- Serve as SME for sample management technologies and industry trends.
- Establish/monitor priorities and performance metrics; ensure SOPs/job aids are current and GxP-compliant.
Qualifications:
- B.A./B.S. (15+ yrs) or M.S. (10+ yrs) or Ph.D. (8+ yrs) in Biology, Chemistry, Biochemistry, Engineering, Biotechnology, or related; or equivalent regulated lab operations/automation/global sample management leadership. Supply Chain/Logistics preferred.
Required Experience & Skills:
- Proven people leadership in a GxP-regulated environment (empowerment, accountability, development).
- Ability to lead through influence in complex, matrixed, global organizations.
- Lab automation (liquid handlers/robotics/automated storage); LIMS implementation/enhancement.
- Strong strategic execution, communication, prioritization, continuous improvement, and trust-building.
Required Skills (examples):
- Bioanalysis, ADME, automation, laboratory automation, continuous process improvement, mentoring/talent development, operational resilience, pharmacokinetics.
Benefits/Comp:
- Salary range: $173,200.00–$272,600.00; eligible for annual bonus and long-term incentive (if applicable). Comprehensive benefits incl. medical/dental/vision, retirement (401k), paid holidays/vacation, and sick/compassionate days.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.