Gene Therapy production using fully integrated iCELLis bioreactor system and leading a group of Bio-process Engineers. Responsible for daily production, GxP.

Lead support to revamping and sustaining Kanban and 5S. Collaborated to achieve faster PCOs and tech transfers; experienced in all manufacturing production processes. Collaborated across a variety of functional groups including Process Development, Data Management, Regulatory, Supply Chian, Project Management, contractors, schedulers, and external vendors. Knowledge of FDA, EMA and other regulatory agencies.• Site sponsor for internal and external audits to maintain inspection readiness. Managed pre-audit walks, observations and corrections. • Supported construction and commissioning of new manufacturing suite, as well as buffer testing, and engineering and qualification runs. • Site sponsor for Work Order notification backlog.• Site sponsor for manufacturing User Furnished Equipment inventory. • Supported Manufacturing Operator Asset Care initiative, identifying equipment and routine work maintenance to be within scope of manufacturing.

Managed six production areas of Downstream Manufacturing (W&D, BP, CC, Column Packing, Purification and Formulation). Assessed with anticipation problems or roadblocks and proposed risk mitigation plans to ensure successful and timely drug delivery. Monitoring of employee adherence to regulatory requirements, SOPs, and other controlled manuals and procedures. Provided oversight and input to execution of work by internal support groups and external vendors and tracking of milestones and deliverables. • Collaborated in Class A audits and gained site Class A certification. Supported sustainment of Class-A and enforced Lean initiatives to make site a multi-product facility.• Appointed sponsor for Safety in downstream Manufacturing department for three years.• Coordinated Safety audits, performed Job Hazard Assessments(JHA), conducted Safety training audits, lead and managed safety improvements and implemented engineering controls to maintain site compliance with CAL-OSHA regulations. • Coordinated TPM program from planning to sustainment phase.Provided input to study protocols and SOP development and implementation.

Coordinated production activities in MOS (Manufacturing Operations Support) for drug production. Responsible for receiving and utilizing correct active ingredients, in-process materials, and parts to achieve finished product. Worked internally with support groups such as Quality Assurance, Technical Operations, Product Development, Process Science and Project Management to ensure successful drug manufacturing goals were met.Assigned responsibilities to team for troubleshooting equipment; verified that process steps were performed in accordance with Compliance to Quality Policies, GMP and Safety regulations. Guided coworkers on creation of Development Plans and end-of-year Performance Reviews. Responsible for Process Validation, Cleaning Validation, and drug substance in-process samples to support commercial products.Responsible for schedule oversight, tracking of raw materials and components, and raw materials qualification.Writing and revising Standard Operating Procedures (SOPs).Responsible for understanding and executing Process Validation (PV) and Cleaning Validation (CV) protocols and the collection of required non-routine samples.Responsible for writing and/or reviewing associated deviations, Out Of Trends (OOT) and Out Of Specifications (OOS).Participation in site audits to ensure compliance with GMP and readiness for inspections.Partnered with Quality Assurance and Quality Control, assisting in issue resolution of quality related issues that impacted GMP compliance or other risks.

Participated on site start-up activities and managed equipment commissioning in Buffer Prep, Buffer Hold and Media Prep in Upstream. Executed Installation Qualifications,Operation Qualifications, and Performance Qualifications for new equipment in Upstream and Downstream Manufacturing.Trained new employees in Upstream Manufacturing processes, Environmental Monitoring (EMs), LabWare LIMS, Integrity Testers, pH Meters, Osmometers, BSCs, Media and Buffer preparation ensuring they understood procedures and worked according to GMP and Safety.Verified P&IDs, Turn Over Packages, Equipment Modules, and Equipment Qualification Manuals during start-up phase.Procured miscellaneous equipment for Upstream manufacturing and created several Safety Operating Procedures for drug production.Responsible for receiving raw materials, active ingredients and parts for successful production campaigns.Responsible for routine and non-routine product sample collection or to support Cleaning Validation or Process Validation protocols.Qualified to write deviations to process and Standard Operating Procedures.Participated in internal area audits to ensure employees were maintaining adherence to compliance with GMP and other regulatory requirements.Monitored process steps , troubleshot issues, and discussed mitigation ideas with my Leads and Supervisor.Collaborated with cross-functional groups such as Maintenance, Calibration, QA and QC for daily activities.

Supported all under construction site activities. Worked with Engineers and external vendors for equipment purchasing and installation.Interpretation of P&IDs and verification of equipment installation. Escalated installation anomalies for timely corrections. Participated in new equipment testing for Performance Qualification (PQs)Took active part on development and implementation of new Standard Operating Procedures.Active participation and ownership of equipment commissioning such as Installation Qualification, Operation Qualification, Performance Qualifications and it's Validation process.Supported Media make up, Bioreactor inoculations, cell growth and automated recipe monitoring.Performed and trained new employees on CIP, SIPs, Harvest train, and process.Responsible for collection of routine and non-routine samples for production and to support Process Validation and Cleaning Validation protocols.

* Monitoring production using mills, bag houses (dust collectors), presses and environmental monitoring.* Transferring final product from recovery to final packaging* Operation of fully automated packaging system, equipment monitoring and troubleshooting* Performance and troubleshooting of presses and skids* Use of online caustic/acid injections to control specific process pH parameters* Product precipitation and recovery* Performance and troubleshooting of conical dryers* Weighing and dispensing raw materials* Creation and revisions of process SOPs* Semi automatic CIP/SIP of 3000L media vessels, and well as 20,000 and 40,000L Bioreactors* Manual Caustic and acid make up in a 800L tank for CIP * Sampling medias, sampling bioreactors prior and post inoculations and transfers* Daily responsibility of maintaining 18 Bioreactors or 14 media tanks* IPA production and supply to precipitation process area (20,000L TK)* Recovery of spent alcohol* Water treatment plant monitoring and troubleshooting equipment issues. IO water make up and supply. RO water production.* Running chillers, heaters, compressors, 4000L filter leaves, and cuno filters* Use of Delta-V and Rosemount systems to run process operations