Director, Regulated Bioanalytics, Sample Management

Job Overview

The PDMB Regulated Bioanalytics Department seeks a strategic, people‑centered Director to lead the Regulated Bioanalytics Sample Management function. The position will be based across our West Point and Springhouse, PA sites, with global oversight of associates in Schwabenheim, Germany. The director will manage receipt, handling, and distribution of clinical samples and reagents to enable regulated bioanalytical studies for small molecules, biologics, and vaccines from non‑clinical through clinical phases.

• Lead through empowerment—establish direction and accountability while enabling teams to operate independently.
• Recruit, develop, and retain talent; provide coaching and mentorship that grow future leaders.
• Build a culture of trust, ownership, and continuous learning.
• Influence across functions and geographies, building strong partnerships with Clinical Operations, IT, Quality, and global stakeholders.
• Translate organizational priorities into clear objectives and ensure alignment with division goals.
• Champion innovation and continuous improvement, encouraging curiosity and challenging the status‑quo.

• Provide overall leadership and strategic direction for global sample‑management operations.
• Lead teams responsible for sample receipt, processing, aliquoting, storage, and distribution.
• Develop and sustain strong partnerships with Clinical Operations to improve end‑to‑end study execution.
• Oversee evaluation, implementation, and optimization of LIMS and automation systems.
• Partner with IT to integrate automation platforms and data systems.
• Represent the organization during internal and external audits to ensure inspection readiness.
• Act as subject‑matter expert in sample‑management technologies and industry trends.
• Establish and monitor performance metrics aligned with division objectives.
• Maintain current, compliant SOPs, job aids, and processes under GxP requirements.

• Bachelor’s degree in Biology, Chemistry, Biochemistry, Engineering, Biotechnology, or related discipline with at least 15years of experience; or Master’s degree with at least 10years; or PhD with at least 8years, plus equivalent experience in regulated laboratory operations, automation, or global sample‑management leadership.
• Experience in supply chain or logistics within a life‑sciences or regulated environment.

• Demonstrated success leading teams in a GxP‑regulated environment.
• Strong influence across complex, matrixed, and global organizations.
• Experience with laboratory automation technologies (liquid handlers, robotics, automated sample‑storage systems).
• Experience implementing and enhancing LIMS or related laboratory systems.
• Strong communication, strategic thinking, and operational execution abilities.
• Track record of driving continuous improvement and innovation.
• Organizational and prioritization skills in a multi‑site environment.
• Ability to build trust‑based relationships with senior leaders and cross‑functional partners.
• Commitment to fostering a culture of collaboration, inclusion, and professional growth.

• ADME, Automation, Bioanalysis, Biopharmaceuticals, Clinical Data, Cross‑Cultural Awareness, Innovation, Laboratory Automation, Mentoring Staff, Operational Resilience, Strategic Direction, Talent Development, Team Leadership.

Salary range: $ – $. Successful candidates will be eligible for an annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, healthcare insurance, retirement benefits (401(k)), paid holidays, vacation, compassionate and sick days.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.