Janet Colón Email & Phone Number

United States

United States

Technical leadership for Drug Substance and Drug Product operations for more than 10 contract manufacturing sites across the globe and over 5 products.

Puerto Rico

Over 15 years of experience in the Biotech and Pharmaceutical industry. Extensive experience in the areas of engineering, management, process development, leadership and mentoring, and problem-solving. Knowledge in GMP compliance and FDA requirements for Therapeutic Biological and Small Molecule Products. Process Development experience in Scale-up, Technology Transfer, Process Optimization, and Process Validation. Knowledge in fermentation and mammalian cell culture processes. Completed Amgen Operational Leadership Program for Director Level in 2018.

Puerto Rico

Managed the Process Development Process Engineering group, provided daily support to cell culture operations at AML by applying scientific knowledge, analytical thinking and troubleshooting skills. Completed inspections of regulatory agencies, technology transfer and process improvement projects as the Process Engineering lead.

Puerto Rico

Managed the manufacturing and packaging operations for a solid drug product organization. Established key initiatives for improving productivity using Lean Manufacturing principles. Planned and managed operational budget and finances associated to small molecule business. Project lead for new product introduction including transforming operations to multiproduct manufacturing. Supported process deviations, CAPAs, change controls, process monitoring summary reports, and all documentation changes. Knowledge in granulation, compression, coating, and packaging operations for solid manufacturing.

Puerto Rico

Managed the Process Development Process Engineering and provided daily support to both upstream fermentation and downstream purification operations. Conducted Six Sigma project to reduce cycle time and improve processes. Leader of the Raw Material Team in charge of overseeing issues and follow up on actions required to reduce manufacturing impact due to raw material events. Project management for large cost reduction initiatives (>$1M)

Daily support to upstream fermentation process including seed and main fermentors, microfiltration and diafiltration, and centrifugation operations. Supported downstream manufacturing areas including Inclusion Body Recovery (harvest through centrifugation), Protein Refolding, Chromatography and Ultrafiltration and Diafiltration operations. Knowledge in Failure Mode and Effect Analysis (FMEA) performed prior to initiating process characterization work. Executed at scale column packing test runs to support resin supplier changes.