General Lab Ops Manager - Chemistry - Cardinal Health
Mansfield, MA
About the Job
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, Chem 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. The Chemistry Service 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.
Responsibilities
Manage Corporate General Laboratory Operations for testing and support for Chemical Characterization testing of medical device and solid dose pharmaceutical development, registration, commercialization, and lifecycle management.
Establish Center of Excellence for the design, justification, execution, reporting, and submitting of Chemical Characterization studies.
Work closely with product development, toxicology, regulatory affairs, and product lifecycle management functions.
Provides the chemical data used to register, commercialize, and support safe and effective 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.
Prepare, present and defend capital and non-capital budgets consistent with corporate priorities and evolving technical needs of the E&L and pharmaceutical test Center.
Supports laboratory tasks including Extractable and Leachable studies; instrument method development, feasibility, and validation; and compendial verifications and analysis.
Authors and reviews standard operating procedures for testing methodologies.
Supervise General Laboratory Operations staff.
Organize and schedule essential laboratory services.
Manages the inventory of essential laboratory supplies for Advanced Analytical Operations (AAO) department.
Coordinate activities to support Advanced Analytical Operations.
Works with Director of Chemistry, Scientific Services to develop and defend operating and capital expense plans related to Chemical Characterization, E&L, EO Residuals, pharmaceutical testings and other regulated testing programs and R & D supports, representing the needs of General Laboratory Operations.
Manages operational and capital expenditures to budget.
Assist Study Directors in Protocol and Proposal Development, data processing and reporting.
Qualifications
B.S. or M.S. in a scientific/engineering field, master’s degree or equivalent experience preferred.
8 – 12 years’ experience in a regulated GMP/GLP analytical laboratory; 4 years of which is in a managerial capacity leading a pharmaceutical analysis, or E&L Laboratory.
Experience operating and maintaining the specific brand and models of relevant instruments within elemental analysis (e.g., Agilent ICP-MS and ICP-OES systems) is preferred.
Capable of operating basic laboratory instruments and performing basic analytical testing.
Must have a working knowledge of the theory and practice of analytical techniques and methodologies applied to E&L, pharmaceutical analyses including instrument operation and data analysis.
Proficient in Microsoft Office, LIMS and laboratory operation software systems.
Thorough understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) to ensure 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 and pharmaceutical impurities /degradation products.
What is expected of you and others at this level
Manage the day-to-day operations and quality of the General Lab 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 lab personnel.
Oversee creation of brand-new analytical chemistry lab, including facilities, instrumentation, and personnel.
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 General Operations for E&L, EO Residuals, and pharmaceutical testing programs 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 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.
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 device.
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 of systems and procedures.
Works independently and as part of a team, displaying self-motivation and adaptability.
Supervises and mentors a small team of less experienced team members.
Ensures that the scheduled analytical tests are done according to the test specification, test method and working instruction.
Anticipated salary range: $136,500 - $194,500
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: 10/4/2024 *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.
