Ryan McGee

About Ryan McGee

Dedicated pharmaceutical professional with extensive experience in bioanalytical…

Experience

1. Associate Director, Bioanalysis

   Incyte

   Feb 2022 — Present

   Manage a team of highly skilled Scientists providing in-house regulated bioanalytical support for preclinical GLP TK through registration studies Manage the bioanalytical outsourcing for multiple programs ranging from early development through registration studies Evaluate new CRO’s and conduct periodic assessments of existing vendors, working closely with QA to qualify vendors Skilled at contract negotiation and setting up MSA’s and SOW’s Manage legal contracts, requisitions, budgets, budget forecasting, and invoices for bioanalytical outsourcing and external consultants Coordinate with various internal groups and CRO’s to ensure study timelines are met, at times providing rapid data turnaround to support dose escalation studies Review and approve method validations and sample analysis data ensuring regulatory requirements are met Established interdepartmental collaborations, developing standards for Lab Manual design, Central Laboratory documents, and PK sample collection procedures, streamlining the study start up and various process improvments Review/Approve central laboratory worksheets (CLW) defining handling procedures for PK samples Coordinate with Data Management for PK sample reconciliation Manage and oversee all operational aspects of the regulated bioanalytical laboratory Created and manage the Sample Management group to support regulated bioanalysis Maintain equipment maintenance and calibration schedules, manage service contracts, and operational budget Coordinate and approve the qualification of new equipment and facilities improvements System Owner for validated computer systems, working closely with QA CSV to manage validation and change control activities. Skilled in writing IQ/OQ/UAT scripts Expertise in drafting Standard Operating Procedures and Work Instructions

Education

• University of Notre Dame

  Bachelor of Science (BSc), Biochemistry

Skills

• Biochemistry
• Glp
• Analytical Chemistry
• Hplc
• Ind
• Elisa
• Chemistry
• Pharmacokinetics
• Sop
• Assay Development
• Cell
• Lc-Ms
• Toxicology
• Protein Chemistry
• Fda
• Bioanalytical Chemistry
• Lims
• Mass Spectrometry
• Drug Discovery
• Dmpk
• Gmp
• Clinical Development
• Bioanalysis
• Pharmaceutical Industry
• Chromatography
• Validation
• Drug Metabolism
• Laboratory