Luke Werrett

About Luke Werrett

Life Sciences Professional with expertise in:Product Development – Sourcing and documenting raw materials, scaling up process formulation from laboratory to clinical and exhibit batches, definition and verification of critical processing parameters and ranges, specifying intermediate hold times and storage conditions, authoring abbreviated new drug application (ANDA) process sections, and addressing FDA responses and information requests.cGMP Manufacturing – Leading operations groups during campaigns, hands-on experience with human derived and cell culture derived API, training department personnel for various roles in MES/ HMI / automation systems, investigating adverse events and developing corrective actions, authoring batch records and standard operating procedures and executing performance qualifications. Capitol Projects – Planning project timelines, identifying and corresponding with contractors and vendors, developing URS documents, selecting equipment, generating and approving drawings, execution of FAT and SAT and performing risk assessments.Validation – Development and execution of IQ/OQ/PQ protocols for equipment, processes, automation, cleaning and sterilization.Automation – Linking PLC inputs and outputs with GMP documentation systems, modifying existing code for efficiency, adding code for new equipment, composition and maintenance of manufacturing execution systems (MES), and on-call trouble shooting.Process Optimization – Bottleneck mitigation, statistical process control, design of experiment, and identifying new an/or improved equipment and technologies.

Experience

1. Principal Formulation Scientist

   somafina

   Mar 2024 — Present

Education

• Brigham Young University

  BS, Chemical Engineering

  2003 — 2007

Skills

• Cross-Functional Team Leadership
• Mes
• Manufacturing
• U.s. Food and Drug Administration (Fda)
• Process Optimization
• Quality Assurance
• Testing
• Automation
• Pharmaceutical Industry
• Business Process Improvement
• Fda
• Root Cause Analysis
• Gmp
• Validation
• Technology Transfer
• Process Control
• Biotechnology
• Six Sigma
• Engineering
• Process Development
• Process Improvement