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.

 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.

 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.

 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.

 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.

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.

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.

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