Director, Regulated Bioanalytics, Sample Management

Job Description

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.

Role Overview

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.

Key Leadership Expectations

• Lead Through Empowerment
  Establish clear direction and accountability while enabling teams to operate independently. Build a culture of trust, ownership, and continuous learning.

• Demonstrate Proven People Leadership
  Recruit, develop, and retain talent. Provide coaching and mentorship that grows future leaders and strengthens organizational resilience.

• Influence Across Functions and Geographies
  Build strong, trusted partnerships across Clinical Operations, IT, Quality, and global stakeholders to drive aligned outcomes and process improvements.

• Drive Strategic Thinking and Execution
  Translate organizational priorities into clear objectives for the sample management function, ensuring alignment with division goals and long-term capabilities.

• Champion Innovation and Continuous Improvement
  Encourage curiosity and challenge the status quo to advance technologies, processes, and ways of working.

Core 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

Education

B.A./B.S. with at least 15 years, M.S. with at least 10 years, or Ph.D. with at least 8 years of relevant experience in Biology, Chemistry, Biochemistry, Engineering, Biotechnology, or related discipline. Equivalent experience in regulated laboratory operations, automation, or global sample management leadership will also be considered.  Supply Chain / Logistics (life sciences or regulated environment preferred)

Required Experience & Skills

• 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

Signature Leadership Traits (Critical for Success)

• 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

Required Skills:

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-Oriented, Strategic Direction, Talent Development, Team Leadership

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is

$173,200.00 - $272,600.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include 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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

06/10/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.