Director, Regulated Bioanalytics, Sample Management
About The Position
The PDMB Regulated Bioanalytics Department is seeking a strategic, people-centered Director to lead our Regulated Bioanalytics Sample Management function. This leader will be based across our West Point and Springhouse, PA sites, with global oversight of associated staff and processes in Schwabenheim, Germany. Our sample management teams play a critical role in enabling the successful execution of regulated bioanalytical studies by ensuring the seamless receipt, handling, and distribution of clinical samples and reagents. These studies support the development of small molecules, biologics, and vaccines from non-clinical through clinical phases. This role requires a proven leader who empowers teams, builds trust, and drives results through influence, not oversight intensity. The successful candidate will foster a high-performing, collaborative culture, enabling teams to operate with accountability, ownership, and continuous improvement. The Director will lead all aspects of global sample management operations, ensuring excellence across West Point (PA), Springhouse (PA), and Schwabenheim (Germany). This individual will build strong cross-functional partnerships, particularly with Clinical Operations, to improve end-to-end study execution from clinical sites through bioanalytical data delivery. This leader will 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.
Requirements
- 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
- Empowering leader who delegates effectively and avoids micromanagement
- Strong coach and mentor who develops future leaders
- Calm, steady presence who drives clarity and alignment in complex environments
- Collaborative influencer who builds trust across functions and geographies
- Forward-thinking mindset with a passion for innovation and continuous improvement
Nice To Haves
- Supply Chain / Logistics (life sciences or regulated environment preferred)
Responsibilities
- Provide overall leadership and strategic direction for global sample management operations, ensuring consistent, high-quality execution across sites
- 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
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays, vacation, and compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Director
