James Odonnell

About James Odonnell

Process Development professional with over 20 years experience in Biotech Industry with primary focus on process validation and process optimization/characterization. Strong understanding of risk analysis and statistical analysis. Excellent communication, organizational, planning and problem solving capabilities. Current role is process validation group leader who leads validation personnel in planning and scheduling validation activities. Specific qualifications and technical skills include-Extensive experience using Design of Experiments (DoE) to study process variables and improve/optimize the process and demonstrate process robustness-Developing pre-process validation activities using QbD approach, FMEA, cause and effect analysis and DoE-Technical transfer of process from laboratory to production-Synthesis of Oligonucleotides (DNA/RNA) using AKTA Oligopilot and Unicorn software-Prep scale purification development and DoE studies-UF/DF development and DoE studies-Developing protocols and writing reports for process validation-Scale down of process for research and experimentation-Technical report writing including interpretation of data-Statistical analysis including ANOVA, Cpk and DoE (working knowledge of Design Expert and JPM statistical software)-Strong knowledge of large and small scale chromatography including HPLC, Affinity and Ion exchange chromatography-Familiarity with cGMP guidelines, ICH guidelines and Safety regulations (OSHA, EPA and NRC-Formal supervisor for process validation group direct reports.

Experience

1. Principal Scientist

   Nitto Avecia

   Sep 2015 — Present

Education

• Harvard University

  ALM (Masters of Liberal Arts), Biology

  1998 — 2002

• UMass Boston

  BS, Major: Biology, Minor: Chemistry

  1991 — 1994