NELDWIN COLÓN

Supervision, operation, and troubleshooting of the following:

• AKTA Chromatography systems (Affinity, Size Exclusion, Monolithic Technology, Ion Exchange).
• Tangential Flow Filtration (TFF), UF/DF, depth filtration, and sterile filtration, virus filtration and inactivation, and large-volume mixing systems (XDUO).
• GMP documentation, SOP drafting and editing, logbooks, Electronic Batch Records (MasterControl eMBR), deviations, change controls, and CAPAs.
• Aseptic and sterile operations, contamination prevention, working in clean regulated environments (ISO, GMP, USP, EP).
• Process monitoring (flow rates, pressure, pH, conductivity, UV absorbance).
• Scale-Up and MFG execution (Tech transfer support from PD Lab to GMP production).
• Lead and coach MFG Technicians during purification operations.

• Lead training on the downstream purification processes as, Chromatography (Akta Systems), TFF (Kr2i), Harvest clarification, aseptic techniques.
• Technical writing to include investigations, line assessments, and corrective actions.
• Create, revise, and assist with the preparation of documentation for activities, actions, and results using GDP.
• Lead training on all document modifications prior to effective date.
• Investigate manufacturing deviations; close out deviations, CAPAs, as needed.
• Author and review, work Instructions, and MBRs (Master Batch Records) for cGMP operation.
• Coordinate cross-functionally with other departments as required.
• Creation of training modules and resources to ensure that SOPs are covered.
• · Monitor KPIs and training to meet strategic goals and compliance.

• Performed method development, product and process development, scale up and scale down processing and purification, leading several activities including research and product/process development for current and new viral products
• Led operation and maintenance of lab-scale chromatography systems and columns (GE Akta systems, Unicorn software, Ion exchange, Affinity, size exclusion)
• Led operation and maintenance of lab-scale systems including manual and automated normal flow and TFF (Kr2i, KMPi), depth filtration, and clarification systems
• Analytical chemistry, protein biochemistry and molecular biology methods such as HPLC, gel electrophoresis, TCID50, A260 viral particle titer
• General laboratory methods: filtration, centrifugation, bioseparations, spectroscopy
• Performed product testing in support of Research & Process Development
• Led and assisted in the drafting and reviewing of SOPs, work instructions (PDPR), study and development plans, run and experiment reports, including the Tech Transfer of these into the GMP facility
• Supported the initiation of investigations, deviations, and implementation of corrective actions
• Assisted in the Tech Transfer process, training the Manufacturing personnel at the time of process hand over to the GMP suite
• Provided tech transfer support to MS&T, Manufacturing, and QA, as needed
• Led adenovirus culture and purification as a Technical Lead (PI), supporting and coordinating R&D, IPT, QC, and shipping activities
• Project task coordination using Smartsheet, Microsoft Excel, PowerPoint, etc.

• Supported Process Development activities to ensure that viral purification processes were successfully established and transferred to the Manufacturing department for its replication at a cGMP regulated facility
• Experience as: General laboratory methods, filtration, centrifugation, bioseparations, spectrophotometry
• Performed product testing in support of R&D Process Development.
• Assisted in research, product and process development for current and new products
• Operated and maintained lab-scale chromatography systems and columns (GE Akta systems, Unicorn software, Ion exchange, Affinity, size exclusion)
• Operated and maintained lab-scale systems including manual and automated normal flow and TFF (Kr2i, KMPi), depth filtration, and clarification systems
• General analytical chemistry, protein biochemistry and molecular biology methods such as HPLC, gel electrophoresis, A260 particle titer
• Wrote SOPs, work instructions (PDPR), study and development plans, run and experiment reports, and facilitate the Tech Transfer to the GMP suite
• Provided Tech Transfer support to MS&T, GMP Manufacturing, QA, and other departments as needed.

• Supported cGMP manufacturing activities to ensure that investigational materials for pre-clinical and clinical use were provided to clients in compliance with applicable regulations.
• Experience as: Purification of recombinant protein and viral vectors
• Operation of ÄktaPilot and ÄktaReady equipment
• Affinity and ion exchange chromatography processes
• Ran Mobius, KR2i and custom made equipment for UF/DF processes
• Operation of CR4i centrifuge and Ultracentrifuge
• Trouble-shoot technical problems on manufacturing processes
• Reviewed executed production batch records (PBRs)
• Deviations, investigations, change controls and planned variances
• Wrote of SOPs, PBRs, CAPAs, RMS and qualification protocols
• Optimization and/or development of downstream processes
• Supported the Tech Transfer process in coordination with the Process Development team to ensure a robust purification process was transferred to the GMP Manufacturing facility.

• Executed biotechnology operations in compliance with the SOPs, cGMPs, and high-quality standards.
• Capture and Purification: Humira (adalimumab) and Entivyo (vedolizumab)
• Affinity, Ion Exchange and Hydrophobic Interaction Chromatography columns
• Ultrafiltration (Concentration, Diafiltration)
• Viral filtration
• Bulk Drug Substance sterile bottling
• Spectrophotometry and osmolality tests
• PH and conductivity tests
• Validation support (Takeda Pharmaceuticals)
• Chromatography columns (Fractogel & Protein A)
• Delipid depth filtration
• Viral Inactivation (pH Adjustment)
• SVP (Small Volume Parenterals)
• Final product syringe visual inspection
• TSB media-filled syringes visual inspection
• Batch reconciliation, deviations, CAPAs.