Director, Analytical Chemistry (Chemical Characterization & Stability)

Director, Analytical Chemistry (Chemical Characterization & Stability)

Headquartered in Dublin, OH, Cardinal Health is a global healthcare services and products company. We provide customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories, physician offices, and patients in the home. We are a distributor of pharmaceuticals and specialty products; a global manufacturer and distributor of medical and laboratory products; an operator of nuclear pharmacies and manufacturing facilities; and a provider of performance and data solutions. Working to be healthcare's most trusted partner, our customer-centric focus drives continuous improvement and leads to innovative solutions that improve the lives of people every day.

We are currently looking for a Director, Analytical Chemistry (Chemical Characterization & Stability) to join chemistry services, a key department within QRMA Scientific Services, where we play a critical role in ensuring the quality and safety of medical devices and pharmaceutical products. The Director is responsible for leading a team who are accountable for conducting in-depth laboratory testing, including characterizing the chemical properties of our medical device portfolio and performing essential stability testing for Cardinal Health's distributed pharmaceutical products. We leverage state-of-the-art instrumentation and sophisticated analytical techniques to develop and implement robust test protocols. This includes characterizing medical devices, materials, and processing aids to identify chemical properties of concern and assess potential leachable constituents during clinical application.

Chemistry Services, a vital component of QRMA Scientific Services, specializes in comprehensive laboratory testing for both medical devices and pharmaceutical products. Our team characterizes the chemistries of medical devices and conducts stability testing for distributed pharmaceutical products. Utilizing specialized instrumentation and advanced analytical techniques, we develop and execute test protocols to characterize medical devices, materials, and processing aids for critical chemical properties and potential leachable constituents during clinical use. Additionally, Chemistry Services performs assay and impurity/degradant tests using specialized instruments for the stability and release testing of solid dose pharmaceuticals.

This role is 100% onsite at our state-of-the-art lab in Mansfield, MA location. We are seeking an experienced and dynamic leader to direct our Extractables & Leachables (E&L) and Stability testing laboratories. This role is critical in ensuring the safety and longevity of medical devices and pharmaceuticals through rigorous analytical testing and adherence to global regulatory standards.

Key Responsibilities:

• Strategic Laboratory Leadership: Drive the long-term strategy and operational planning for the E&L and Stability laboratories, encompassing space, IT, capital projects, and resource allocation. Develop and manage comprehensive budgets, staffing, and capacity plans.
• Team Leadership & Development: Lead, mentor, and develop a high-performing team of scientific professionals, fostering a culture of excellence, continuous improvement, and effective service delivery. Oversee recruitment, training, and performance management.
• Technical & Scientific Oversight: Provide expert direction for compliant chemical studies, including Extractables & Leachables (E&L), EO Residuals, and pharmaceutical stability testing, ensuring the safety and longevity of medical devices and pharmaceuticals. Oversee method development, validation, and analytical support for R&D.
• Quality & Regulatory Assurance: Ensure strict adherence to evolving regulatory requirements (e.g., FDA, ISO, EU MDR, GLP/GMP). Manage quality management systems, lead audit preparedness, and maintain necessary licenses and accreditations.
• Stakeholder Engagement & Collaboration: Serve as the primary scientific and technical liaison for internal cross-functional teams, external partners, and regulatory authorities. Represent the function to upper management and support business development activities.

Qualifications:

• Bachelor's degree (Master's preferred) in a scientific or engineering discipline (e.g., Analytical Chemistry, Pharmaceutical Sciences), preferred or equivalent work experience.
• 12+ years of experience in a regulated GMP/GLP analytical laboratory, including 8+ years in a managerial capacity leading a Pharmaceutical or E&L laboratory, preferred.
• Extensive working knowledge of analytical techniques, methodologies, and instrument operation for Extractables & Leachables (E&L) and pharmaceutical analyses, preferred.
• Strong understanding and practical application of GMP, ICH guidelines, FDA, ISO, and EU MDR regulatory requirements for medical devices and pharmaceuticals.
• Proven ability to lead, supervise, coach, and develop high-performing scientific teams, including staffing and capacity planning.
• Demonstrated experience in managing multiple complex projects, developing and defending capital/operating budgets, and ensuring adherence to timelines.
• Excellent interpersonal, written, and oral communication skills, with the ability to effectively present information and foster customer relationships.
• Working knowledge of commercial materials, analytical characterizations, and E&L studies for medical devices and pharmaceutical products.
• Proficient in LIMS, Microsoft Office, and other laboratory operation software systems.
• Strong financial and data analytics acumen to support strategic decision-making and continuous improvement.

What is expected of you and others at this level:

• Provides leadership to managers and experienced professional staff; may also manage front line supervisors
• Manages an organizational budget
• Develops and implements policies and procedures to achieve organizational goals
• Assists in the development of functional strategy
• Decisions have an extended impact on work processes, outcomes, and customers
• Interacts with internal and/or external leaders, including senior management
• Persuades others into agreement in sensitive situations while maintaining positive relationships

Anticipated salary range: $135,400 - $208,150

Bonus eligible: Yes

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 10/31/2025 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.