Chemistry Manager

Cardinal Health•Mansfield, MA

3d•Onsite

About The Position

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

Requirements

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.
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.

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 Team's 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.
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 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 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.