John Bigelow Email & Phone Number

Lawrence Township, NJ, US

Lawrence Township, NJ, US

- Lead specification, design, and implementation of process equipment, systems, and associated process control methodologies in direct support of commercial and clinical manufacturing operations- Perform Facility Fit studies for new product introductions including equipment sizing and allocation, mass balances, facility dynamic capacity analysis, and.

New York, New York, US

- Executed and troubleshot all clinical manufacturing unit operations associated with microbial processing, including upstream fermentation and downstream purification processes, Clean-In-Place (CIP), and changeover operations in a cGMP environment- Mentored and developed colleagues by providing advice, unlocking growth opportunities, and helping them set.

St Louis, Missouri, US

- Tested and validated DeltaV Equipment Modules (EMs), Phases, and Recipes for a single-use clinical manufacturing facility- Qualified and performed data integrity assessments on equipment for a new Quality Control (QC) laboratory- Led the commissioning and qualification (C&Q) efforts of all upstream and benchtop equipment for an innovative continuous.

Paris, France, FR

- Provided daily technical support and data analysis for chromatography and filtration purification operations to ensure on-time product release- Identified process improvements and drive the implementation of corrective and preventative actions (CAPAs) and change controls- Managed a multi-site filter integrity test (FIT) improvement project to reduce.

- Monitor and provide support for manufacturing operations and troubleshoot process issues- Evaluate process data including chromatography trends and column performance/integrity- Participate in investigations and support the implementation of CAPAs in response to investigation findings- Evaluate root causes of deviations and process failures/action limit.

- Performed transition analysis to create a historical database for comparisons- Reviewed and overlaid chromatograms using UNICORN for routine process monitoring and investigations- Led a cross-functional team to implement a Standard Operating Procedure (SOP) that regulated a way to analyze chromatograms for every product produced at Shire HGT and wrote a.

-Supported environmental chamber qualification efforts and any associated discrepancy investigations at Shire HGT.-Performed IOQ protocol generations, executions, execution coordination, and final report generations for -80°C freezers, Ultrafiltration skids, Chromatography skids, and utility systems.-Contractor for Castle Validation Services, Inc. working.

-Developed an equipment performance evaluation tool for the Clean In Place (CIP) process by using Excel and putting together a team of experts that met weekly. This tool is now being automated and passed on to other Shire facilities.-Presented a poster of my project to managers and all of Shire HGT.-Investigated aborts and other suspicious data or trends.