Technical Lab Operations Manager

What Chemistry Services contributes to Cardinal Health

Chemistry Services performs laboratory testing to characterize the chemistries of our medical device products and stability testing for pharmaceutical products of Cardinal Health. Under the umbrella of QRMA Chemistry Services develops and executes test protocols utilizing specialized instrumentation and analytical techniques to characterizes medical devices materials and processing aids for chemical properties of concern or the chemical constituents which may be released when a device is utilized during clinical use. Chemistry Services will also use specialized instruments to perform Assay and impurity/degradant tests for stability and release testing for solid dose pharmaceutical. Chemistry Services is a part of QRMA Scientific Services.

100% onsite in Mansfield MA

Responsibilities

• Manages the Advanced Analytical Operations (AAO) department providing chemical characterization testing and support for medical device development registration commercialization and lifecycle management.

• Establishes a cGMP facility for extractable and leachable chemistry. Collaborates with product development toxicology regulatory affairs and product lifecycle management to deliver the chemical data required for the registration commercialization and safe use of medical devices.

• Develop manage and energize a team of professionals dedicated to providing effective efficient timely and compliant chemical studies to establish the safety of marketed medical devices and pharmaceuticals consistent with current and evolving regulatory requirements and practices.

• Provide analytical testing support for other R&D activities of Cardinal Health as needed

• Develop and retain key team members.

• Authors and reviews standard operating procedures for testing methodologies.

• Organize and schedule essential laboratory services.

• Coordinate activities to support Advanced Analytical Operations.

• Responsible for partnering with the Director of Chemistry Scientific Services in developing and justifying operating and capital budget proposals for Chemical Characterization and other regulated testing programs as well as R&D support acting as a key advocate for the Advanced Analytical Operations Teams requirements.

• Responsibilities include supporting laboratory tasks such as Extractable and Leachable studies instrument method development feasibility and validation and compendial verifications and analysis in addition to assisting Study Directors with protocol and proposal development data processing and report generation.

What is expected of you and others at this level

• Manage the day-to-day operations and quality of the Advanced Analytical Operations of the Analytical Chemistry department.

• Recruit develop motivate and retain a high-performing team consisting of expert SMEs and supporting staff. Oversight of Analytical Chemists and PhD level scientists.

• Develop implement and monitor clear challenging and motivational performance-based expectations for team members fostering a collaborative environment that emphasizes teamwork ongoing improvement effectiveness and efficiency and excellence in study design and implementation.

• Plans organizes and manages resources for Advanced Analytical Operations for Chemical Characterization of Medical Devices (such as E&L) to assure technical conduct regulatory quality and both budget & schedule adherence.

• Manage multiple simultaneous projects with competing and aggressive schedules so that all regulatory commitments are met within agreed-upon timelines.

• Develop justify and manage functions budget balancing staffing and capital resource needs with fiscal prudence.

• Prepare for and participate in internal and external audits by regulatory authorities (FDA EU) and customers.

• Provides broad-based technical and management support to analytical strategies and methodologies throughout the organization.

• Provide primary support to all cross functional teams with respect to analytical testing related matters including liaison with external testing labs and contract vendors evaluation of suppliers raw materials facilities equipment manufacturing processes inspection and testing.

• Represent function to upper management.

• Ensures compliance of functions output with FDA ISO and EU MDR regulatory requirements as applicable to medical devices.

• Support as needed development of SOPs guidance protocols reports supporting laboratory GMP/GLP function in compliance with FDA ICH and other regulatory guidance.

• Support organizational non-Chemical Characterization Analytical Laboratory needs as necessary.

• Provide technical support to stakeholders (Manufacturing operations Corporate Engineering Regulatory and Compliance R&D etc.).

• Partner with EH&S to ensure safety within the laboratory for all lab personnel.

• Serves as contact for scientific and regulatory issues.

• Understands Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) to ensure compliance with systems and procedures.

• Ensures that the scheduled analytical tests are done according to the test specification test method and working instruction.

Qualifications

• B.S. or M.S. in a scientific/engineering field masters degree or equivalent experience preferred. PhD preferred.

• 8 12 years experience in a regulated GMP/GLP analytical laboratory preferred; 4 years of which is in a managerial capacity leading an E&L Laboratory preferred. CRO experience highly desired.

• Capable of operating advanced laboratory instruments and performing advanced analytical testing.

• Must have a working knowledge of the theory and practice of analytical techniques and methodologies applied to E&L analyses including instrument operation and data analysis.

• Proficient in Microsoft Office LIMS Agile Veeva and laboratory operation software systems similar to Agilent ECM and MassHunter.

• Thorough understanding of ISO 10725 ISO 10993 GLP 21 CFRs USP ICH and related GMP compliance of systems and procedures.

• Excellent written and oral communication skills. The incumbent has daily contact with a variety of research personnel technical peers and appropriate managerial personnel as well as frequent contact with customers clients vendors and suppliers. Must be able to accurately and effectively convey recommendations data observations results and problems to co-workers and sponsors.

• Working knowledge of commercial materials analytical characterizations (materials plastics polymers material/plastic additives and metals) and Extractables & Leachable studies of commercial products and/or medical devices.

• Experience with operation of a Laboratory Information Management System (LIMS) and project management a plus.

Anticipated salary range:$138200 - $177750

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:5/3/2026 *

*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 candidates 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.

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