Technical Lab Operations Manager in Mansfield

Chemistry Services performs laboratory testing to characterise 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 utilising specialised instrumentation and analytical techniques to characterise medical devices, materials, and processing aids for chemical properties of concern or the chemical constituents which may be released when a device is utilised during clinical use. Chemistry Services will also use specialised instruments to perform Assay and impurity/degradant tests for stability and release testing for solid dose pharmaceuticals. Chemistry Services is a part of QRMA Scientific Services.

Responsibilities:

• Manages the Advanced Analytical Operations (AAO) department, providing chemical characterisation testing and support for medical device development, registration, commercialisation, 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, commercialisation, and safe use of medical devices.
• Develop, manage, and energise 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.
• Authors and reviews standard operating procedures for testing methodologies.
• Organise 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 Characterisation and other regulated testing programmes, as well as R&D support.
• Support laboratory tasks such as Extractable and Leachable studies, instrument method development, feasibility, and validation, and compendial verifications and analysis.

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.
• Plans, organises, and manages resources for Advanced Analytical Operations for Chemical Characterisation of Medical Devices to assure technical conduct, regulatory quality, and both budget & schedule adherence.
• Manage multiple simultaneous projects with competing and aggressive schedules.
• Develop, justify, and manage function’s 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.
• Provide broad-based technical and management support to analytical strategies and methodologies throughout the organisation.
• Provide primary support to all cross-functional teams with respect to analytical testing related matters.
• Ensure compliance of functions output with FDA, ISO, and EU MDR regulatory requirements.
• Support development of SOPs, guidance, protocols, reports supporting laboratory GMP/GLP function in compliance with FDA, ICH, and other regulatory guidance.
• Provide technical support to stakeholders.
• Partner with EH&S to ensure safety within the laboratory for all lab personnel.
• Serves as contact for scientific and regulatory issues.
• Understand Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Ensure 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, master’s 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.
• 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.
• Proficient in Microsoft Office, LIMS, Agile, Veeva and laboratory operation software systems.
• 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.
• Working knowledge of commercial materials, analytical characterisations 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.

Cardinal Health offers a wide variety of benefits and programmes to support health and well-being, including medical, dental and vision coverage, paid time off plan, health savings account (HSA), 401k savings plan, access to wages before pay day, flexible spending accounts (FSAs), short- and long-term disability coverage, work-life resources, paid parental leave, and healthy lifestyle programmes.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background.