Marcus Cheatham Email & Phone Number

United States

 Leading protocol development and project stability strategy Data reviews at major stability timepoints Protocol design and development based on current regulations and market requirements Author stability studies Advice project team on current global stability requirements Stability packaging site transfer requirements Management of disentanglement projects Respond to global stability emails concerning temperature excursions Working with Regulatory affairs with market reassessment requirements Weekly meetings for project status and project updates

 Responsible for all CQV activities by preparing TOP (Turn-over packages) for every system and equipment including Lyophilizers, Autoclaves, Vial Filling and Coding station, Capper, Washers, WFI, Isolators, automated communication interface system, extension of SCADA systems, Grade C and D controlled classified areas, and CNC areas among other features of new installations like material preparation areas, Compounding area with utility station, Material transfer, RO pre-treat and treatment units. Utility/Facility Qualification Technical Writing  Generating and executing Commissioning IV/OV (Installation Verification/Operational Verification protocols. IOQ/PQ (Installation, Operation and Performance Qualification) protocols. Summary Reports for all systems and equipment assessing critical aspects of each system based on their functionality and requirements

 Maintain compliance of the commercial stability program, which encompasses all commercial products/strengths including starting materials, drug substance, intermediates, drug product intermediates, and drug products. Improve on all stability program sub-processes to ensure compliance and efficiency Effectively communicate with internal and external stakeholders Ensure studies are initiated within project timelines Proactively monitor stability studies to ensure compliance with study protocols, Quality Agreements and Regulatory commitments Perform technical data review and comment resolution internally and with external partners Review OOS/OOE investigations and laboratory deviations Perform data analysis and trending according to industry guidelines Generate and provide stability reports for submission to regulatory authorities Program Management of CMO’s and stability data Monitor and react to key process performance indicators. Author and review SOPs, protocols, and reports May perform in-process, release, and stability testing and/or review independently following established methodology, procedures, and SOPs

 Writing work instructions Writing and reviewing Batch Production Records Writing Specifications containing drawings and list of materials Transportation, storage, certifications, and testing inspection documents Protocols Summary Reports Installation Qualifications Operation Qualifications Process Qualifications Program management of medical device products Assembly and parts standard operating procedures Automated Equipment  Device Components

 Manage creation and tracking of change controls related to assets in CAPA actions Assist client with change control related actions Update SOP’s associated with equipment updates Develop and align specs / URSs for new equipment purchases  Assist client with creation of implementation plans  Technical writing, reviewing, and revising of all documents associated with the specific assignments. Provide guidance and oversight for Process Engineering department related to implementation Manage outside vendor setup of new equipment Program Management  Report updates and concerns/solutions to Sr. Manager – QC Instrumentation  Assist client with validation of equipment including executing of protocols  Collaborate with QC Instrumentation Department to keep all parties informed.  Weekly progress reports indicating recently completed tasks, current tasks, and issues/concerns. Attend Project related meetings (Remote or on-site as needed)

United States

• Support end-to-end QC qualification and validation activities for the QC laboratories.• Author, review, and execute qualification and validation protocols and generate reports, which includes URS, SDS, IQ, OQ, PQ, etc.• Oversee qualification timelines and coordinate with stakeholders to ensure review and approvals of documents.• Oversee investigation for issues encountered during qualification/validation activities.• Work with vendors, Facilities, Engineering, and Quality to support qualification and maintenance activities, which includes onboarding of systems, change records, risk assessments, etc.• Troubleshoot instrument-related issues that arise for the laboratory, determine solutions, and resolve issues.• Ensures instruments in the QC Laboratory are in a constant state of compliance and is inspection-ready by conforming to all regulatory requirements.• Provides support during regulatory, internal, and partner inspections/audits.

Irvine, Ca

Entire PAB production line validation/ revalidation (assembly, filling, etc). Update SOPs/procedures PTRA runs, IQ/OQ/PPQspFMEACAPAs

Austin, Texas Area (Remote)

Develops and maintains equipment validation master plans (VMP), risk assessments, traceability matrices, test case protocols, test cases, validation reports and summary reports for plasma center operating equipment including plasmapheresis and plasma storage equipment, refrigerators and freezers.2. Coordinates supplier performed equipment validation to ensure compliance with regulations, policies and procedures. Ensures supplier provided documentation meets requirements.3. Serves as consultant for test protocol execution and resolves issues.4. Reviews completed validation documentation to ensure actual results meet expected results.5. Reviews temperature excursions and equipment incident reports for appropriate and timely resolution.6. Ensures that all validation deviations are resolved, documented and reviewed for regression testing.7. Oversees the review and approval of operating equipment changes including impact assessment and presents to the Change Control Board.8. Defines and develops validation schedules to ensure that all plasma center equipment are periodically reviewed and assessed for revalidation.9. Develops reviews and revises standard operating procedures (SOPs) consistent with FDA and European Union (EU) regulations and customer requirements.10. Develops processes to maintain validated equipment status per the approved VMP.11. Tracks and trends equipment failures to support process improvement initiatives.12. Prepares monthly equipment validation metrics and reports metrics to the Sr. Director, Corporate Quality and Director, Field Quality.13. Provides guidance to donor center personnel regarding validation policies and procedures.14. Provides validation training materials as required and assists with training as assigned.15. Provides technical support during internal/external audits and regulatory inspections.16. Audits current and/or prospective vendors.

Mesa, Arizona

Cambridge, Massachusetts

Cambridge, Massachusetts

Dallas/Fort Worth Area

Fort Worth, Texas

Tempe, Arizona

Phoenix, Arizona

Chandler, Arizona

Phoenix, Arizona

Chandler, Arizona

Doctor Of Philosophy (Phd), Industrial And Organizational Psychology

PhD in Industrial and Organizational Psychology

Master Of Science (M.S.), Medicinal And Pharmaceutical Chemistry

Master of Science in Pharmaceutical Chemistry

Bachelor Of Science (B.S.), Nutrition Sciences

Bachelor of Science in Nutrition Science