Edwin Abedi Email & Phone Number

Los Angeles, Ca, Us

San Diego, Ca, Us

Design and implementation of Audit & Inspection Management program which includes internal auditing, inspection preparedness, and hosting/responding to external regulatory inspections. Development, implementation, and maintenance of Management Review program for compliance with current regulatory requirements and standards for GxP.Directed Regulatory Compliance program for compliance with current regulatory requirements and standards to ensure new and developing regulatory trends are evaluated for ImmunityBio.Development, implementation, and maintenance of Global Quality Standards program to ensure ongoing compliance of Quality Systems to current regulations and industry guidance for Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP). Oversight of Quality Risk Management (QRM) and Quality Improvement Program (QIP) including design and implementation of electronic systems (Veeva) for execution. Led direct reports and cross-functional team to prepare, host, and respond to FDA inspections of ImmunityBio Contract Manufacturers; developed electronic means of real time inspection tracking and support to streamline inspection process.Creation and implementation of Gap Assessment process to support assessment of regulations, industry guidance, and regulatory trends for improvement needed in internal standards, procedures, and practices for early phase through commercial product. Leading a team of direct reports (Sr. Managers and Senior Associates) to execute objectives outlined by executive management.

Baar, Ch

API batch disposition and releaseBatch record review and issuance SOP, validation protocol review and approvalDeviation, CAPA, OOS investigation, root-cause analysis, effectiveness monitoringValidation IQ, OQ, PQ review and final approvalAnalytical data review and approval Continuous improvementCross-functional workflows to meet site goalsQuality lead on major site-wide buildouts for GMP manufacturing and supportAudit support / SME for Quality OperationsCustomer partnership to meet peptide quality production and release requirementsApproval of internal testing and CoA for raw-material and final drug substanceMethod validation reviewCalibration, PM, work orders, engineering change managementInternal audit / GEMBA walk to ensure continual audit readiness ALCOA+ principles application to review of executed documents

Tokyo, Jp, Jp

Providing Quality guidance and escalated decision making for production process and critical systems supporting site-wide manufacturing under GxP.Developed and managed team of Quality Engineers to perform routine audits of manufacturing floor and process leading to a decrease in non-conformances and safety incidents.Led cross-functional team to streamline frozen plasma storage and transfer process resulting in elimination of discarded lots due to improper handling.Serving as main Quality representative in a cross-functional effort to improve reliability of critical thawing machinery resulting in increased uptime, decreased failures, and improvement of manufacturing throughput.Providing logical decision making with regards to production emergencies and compliance issues with little supervision.Hands on support for manufacturing, engineering, maintenance, and other business critical functions to drive problem solving and effective corrective actions. Quality representative for multiple plant-wide functions (operations, critical systems, facilities engineering, Lot Release, major site-wide projects).Lead and participate in Kaizen to drive improvements and waste reduction.Working with Senior Management to determine lot release strategies and potential impacts related to non-conformances.Development and revision of SOPs to provide guidance and ensure quality and safety objectives are met.Training, mentoring, and guidance of new employees.

Illinois, Us

Quality lead overseeing fractionation activities for Baxalta site including oversight of Quality Engineering activities of two separate buildings.Supervising the activities of fractionation Quality Engineering Operations, Quality Release, and Quality Review departments to ensure timely operations with goal oriented and results driven objectives.Use of DMAIC, and root cause analysis as part of CAPA investigations to determine proper corrective actions and improve product quality, conformance, and cycle time.Using statistical analysis in Minitab to chart and track the soundness of department wide performance as well as determining proper methodology for CAPA related activities.Implementation of quality improvement projects to streamline normal business and manufacturing operations by applying Six Sigma statistical tools.Designing and conducting training activities for newly hired Quality Engineers and Quality Analysts.Designing and performing audits of the manufacturing process to ensure compliance to internal as well as FDA mandated requirements.Leading cross-functional risk management FMEA activities for changes relating to the manufacturing process and Delta-V automation system.Providing Quality Engineering guidance and support for multiple shifts to achieve defined quality goals in an efficient, accurate, and timely manner.Leading ongoing daily Quality and Manufacturing improvement activities requiring hands on monitoring and auditing as part of a cross-functional team. Developing, revising, and reviewing SOPs and controlled documents.Hiring, training, and evaluating personnel.

Deerfield, Illinois, Us

Initiated, reviewed, and closed non-conformance and CAPA/NCR Events to ensure the quality, purity, and safety of manufactured drug product. Root cause analysis, action implementation, and effectiveness monitoring to resolve deviations.Reviewed and approved Manufacturing Engineer’s user interventions performed on the DeltaV automation system to ensure quality standards met during manufacturing.Application of Six Sigma methodologies to resolve quality and production issues.Performed real-time troubleshooting of manufacturing equipment and process deviations with a cross-functional team of Manufacturing Engineers, Supervisors, and Maintenance Technicians. Wrote reports to analyze the results from investigations into manufacturing SOP deviations. Conducted product complaint Adverse Event investigations to assess the potential harmfulness of manufactured and released drug product. Used statistical analysis in Minitab to create control charts to track the soundness of department wide performance of quality related issues such as bioburden failures, CAPA closure times, and more. Performed GEMBA walk-through to identify current and potential manufacturing floor quality problem areas.Collected historical data and trended process parameters using the DeltaV process and batch historian system to support CAPA investigations.Participated in various Kaizens to improve Manufacturing and Quality workflow through application of Lean Six Sigma.

Deerfield, Illinois, Us

Performed protein purification using monoclonal antibody to isolate Factor VIII protein from bulk solutions in order to conduct yield improvement studies.Worked with a team of researchers to investigate the comparability of new monoclonal antibody resin to be used in the purification of antihemophilic Factor VIII via small scale column chromatography utilizing AKTA Avant and Explorer automation machinery.Preparation and execution of studies, and verification and validations conforming to cGMP/CFR to support the implementation of nanofiltration as an additional viral reduction step in the manufacture of Factor VIII.Led a team of five to collect, organize, and apply statistical analysis production data from over three years in order to provide justification for FDA questions.Assisted in the conformance study phase of the introduction of nanofiltration into the manufacturing process.Wrote SOPs for the Q-Sepharose column purification step to be used in nanofiltration.Designed a cycle development plan for a small parts washer in nanofiltration to clean sterile filtration tank parts.Conducted small scale experiments to determine the albumin binding capacity of Q-Sepharose media under current manufacturing parameters.Investigated the effect of ethylene glycol concentration on elution sample recovery percentage using refractrometry techniques.Performed controlled document revisions of SOPs, runsheets, PRFs, and C&E documents in order to include new validated ranges for a variety of steps in the AHF-M MAb purification process.

Deerfield, Illinois, Us

Conducted bench scale and pilot plant scale studies to optimize yields for the production of anti-hemophilic factor (FVIII).Supported and conducted purification of bulk suspension using anti-Factor VIII monoclonal antibody chromatography.Prepared study/validation protocols, final reports, and SOPs.Performed investigations into protocol deviations.Conducted analyses of in-process samples utilizing ELISA and other biochemical methods.Supported the execution of validation protocols involving manufacturing scale production.Supported pilot plant operations for yield improvement and process improvement activities.Performed sample preparation, collection, and submission for testing.Trained and qualified technicians to properly execute various protocols.Performing equipment maintenance to ensure proper calibration and data integrity.

Conducted my own developed syntheses, purification, and analysis of putative anti-cancer agents leading to published papers in organometallic chemistry journals.Developed novel methods for the synthesis of putative aromatase inhibitors for breast cancer treatment.Performed root cause analysis to determine failures in experimental design.Purified highly sensitive compounds via chromatography, PTLC, and filtration.Properly used and disposed of hazardous laboratory chemicals under GLP/OSHA guidelines.Maintained detailed accounts of experiments, procedures, results, and observations in a personal laboratory notebook under GDP guidelines.Trained new team members and supervised their performance to ensure proper execution of experiments.

Abbott Park, Illinois, Us

Worked under medical devices regulations to analyze and ensure the quality and final release of diabetes test strips.Performed testing of raw materials used in the manufacturing of test strips including identifying aberrations and executing exception reports to control quality of released devices.Worked in a clean room to test and assess developing continuous glucose monitoring system.Participated in testing protocols for continuous glucose monitoring devices providing valuable feedback for design and functionality during product use.Quantifying test strip integrity and precision through sampling and testing.Worked on cross-functional teams with manufacturing, packaging, and quality departments to review and release finished products.

Bachelors, Biochemistry And Molecular Biology

Bachelor’S Degree, Mathematics