Evangelos D. Kustubardis
Dorchester,Massachusetts
Summary
Quality Professional with over 10 years of experience in early-stage biotechnology and commercial pharmaceutical companies. Results driven, skilled leader with progressive experience in Quality Assurance Operations and Quality System Management. A collaborative problem-solver that provides quality system compliance oversight and guidance on phase appropriate QMS. Demonstrated experience in leading process improvement initiatives and evaluating quality matters utilizing a risk-based approach. Ability to lead and manage projects and cross-functional teams within corporate objectives and project timelines.
Overview
11
11
years of professional experience
Work History
Quality Assurance Manager
Intellia Therapeutics
Cambridge, MA
04.2022 - 01.2025
- Lead the implementation of phase-appropriate quality standards, policies, and procedures
- Review batch records and data in support of drug substance and drug product release activities for early phase and late phase cell and gene therapies
- Lead process for reviewing manufacturing deviations, investigations, and OOS/OOTs
- Spearhead the development and training of QA Associates as it relates to Quality events and batch record review activities
- Support process performance qualification (PPQ) activities, including the review of validation protocols/reports and quality risk assessments
- Partner with strategic external partners (i.e., CDMOs) in support of late phase clinical manufacturing and manage resolution of complex investigations
- Drive the continuous improvement of quality processes and systems, seeking opportunities for innovation and efficiency
- Participate in inspection readiness activities and provide support during site inspections
- Facilitate QP declaration requests, updates to filings and QP Release supporting documentation
Quality Assurance Lead
Intellia Therapeutics
Cambridge, MA
08.2020 - 04.2022
- Execute quality oversight of internal manufacturing of clinical drug substance and drug product through lot disposition for early phase cell and gene therapies
- Offer on the floor QA support and coordinate timely resolution of comments related to batch production record reviews
- Lead Manufacturing Deviation evaluations, GMP investigations, and CAPAs
- Provide guidance on Change Control plans and approve change controls for implementation
- Partner with Process Development and Manufacturing for technology transfer as well as to qualify and validate the manufacturing processes and Quality Control (QC) methods
- Function as QA lead for CDMO activities, including analytical method validation, and clinical drug substance manufacturing
- Perform internal audits and manage follow-up actions
Sr. Quality Assurance Specialist, Compliance
Vedanta Biosciences
Cambridge, MA
06.2018 - 08.2020
- Monitor the performance of the Veeva Vault QMS
- Provide quality oversight for Deviations, Change Controls, CAPAs and Supplier Management Program
- Lead the implementation, training, usage, and ongoing configuration changes to the electronic Veeva Vault QMS system (eQMS)
- Author, review and approve QMS procedural documentation and work instructions
- Generate and present metrics related to quality system performance at the Quality Management Review
- Author, coordinate, negotiate, and maintain quality agreements between Vedanta and suppliers
- Manage Internal audit program and support mock regulatory inspections
- Support the GxP vendor qualification process and maintain qualified vendor list
- Streamlined the deviation procedure by improving the investigation process
- Reduced the number of days needed to close deviations from 45 to 30 days
Engineer II
Azzur Consulting of New England
Cambridge, MA
05.2017 - 06.2018
- Perform the quality review of GMP documentation: Master Batch Records (MBRs), Deviations, Investigations, CAPAs, protocols and reports (stability, validation and method)
- Establish KPIs and oversee trending of key performance metrics associated with the QMS processes
- Support Quality Management Review activities
- Report and escalate compliance issues to management
- Provide quality review, approval, and impact assessments on change control records
- Facilitate the Change Control Review Board (CCRB) and maintain associated documentation
- Develop, maintain, and continuously improve GxP training curricula and role-based course content for the QMS processes
- Provide training, access, and support to Employees for Veeva Quality Vault
- Provide oversight, support issue management, and drive continuous improvement as it pertains to the eQMS
- Liaise with IT regarding system enhancements, driving effective prioritization in consideration of business and compliance impact
Engineer II
Moderna Therapeutics
Cambridge, MA
11.2016 - 05.2017
- Assist in the commissioning of a custom fit-for-purpose Single-Use personalized RNA Manufacturing System, TFF and Chromatography Skids to support the production of an Investigational Personalized Cancer Vaccine
- Responsible for generation of lifecycle documentation for the Single-Use personalized RNA Manufacturing System and skids
- Review and revise vendor commissioning documentation, including FAT and SAT documents
- Develop and execute Installation and Operational Qualifications for the systems
Engineer II
Shire Pharmaceuticals
Cambridge, MA
05.2016 - 07.2016
- Assist in the generation of spare parts history and risk ratings based on SME input and historical failures
- Facilitate Quality Risk Assessments using tools such as Failure Modes and Effects Analysis (FMEA), Risk Estimation Matrix (REM) and Comparison Matrix
- Create and revise cross-site GMP documents, including SOPs and Risk Assessment Reports
Engineer I
Regeneron Pharmaceuticals
Rensselaer, NY
09.2015 - 05.2016
- Provide technical support in the execution of qualification activities for the startup of new manufacturing production areas
- Responsible for generation and execution of IQ, OQ and PQ protocols, System Impact Assessments, Equipment Risk Assessments, System Requirement Documents for Parts Washers, Single Use Mixing Systems, and controlled temperature units (CTUs)
- Analysis of validation data, summarization of C&Q test activities, assembly of Turnover Packages
Engineer I
Moderna Therapeutics
Cambridge, MA
06.2015 - 09.2015
- Provide technical support in the execution of qualification activities for the startup of new manufacturing production areas
- Responsible for generation and execution of IQ, OQ and PQ protocols, System Impact Assessments, Equipment Risk Assessments, System Requirement Documents for Parts Washers, Single Use Mixing Systems, and controlled temperature units (CTUs)
- Analysis of validation data, summarization of C&Q test activities, assembly of Turnover Packages
Quality Engineer
ExterNetworks
10.2014 - 06.2015
- Provide technical support in the design, development, and implementation of the Test Method Validation program for Medical Devices
- Develop Production Inspection Plans for the TM Ankle Talus, TM Ankle Tibia and TM Glenoid Medical Devices
- Review and improve gaps in the visual inspection of TM Ankle Talus and TM Ankle Tibia
- Collaborate with a cross functional team to determine critical features of the devices employing FMEA
- Perform Gage R&Rs on features that are determined to be critical
Validation Engineer
GR Validation and Compliance
11.2013 - 08.2014
- Provided technical support in the implementation of the Cleaning Validation/Verification program
- Aided the analysis and trending of sample results for Conductivity, TOC, and Endotoxin with the use of Minitab
- Supported the development and review of CIP/COP protocols for Parts Washers, Tanks and Manual equipment
- Assisted in the development of SOPs related to the execution of the cleaning procedure for Amicon Skid and Parts Washers
Education
MS - Pharmaceutical Manufacturing
Stevens Institute of Technology
Hoboken, NJBS - Chemical Biology
Stevens Institute of Technology
Hoboken, NJMS - Management
University of Illinois Urbana-Champaign
Urbana-Champaign, ILSkills
- Quality Risk Management
- Failure Mode and Effects Analysis (FMEA)
- Lean Six Sigma (DMAIC)
- Root Cause Analysis
- Operational Excellence
- Internal Auditor
- Process Validation
- Equipment qualification
- Gage R&R
- Minitab
- Visio software
- Veeva Vault
- TrackWise
Timeline
Quality Assurance Manager
Intellia Therapeutics
04.2022 - 01.2025
Quality Assurance Lead
Intellia Therapeutics
08.2020 - 04.2022
Sr. Quality Assurance Specialist, Compliance
Vedanta Biosciences
06.2018 - 08.2020
Engineer II
Azzur Consulting of New England
05.2017 - 06.2018
Engineer II
Moderna Therapeutics
11.2016 - 05.2017
Engineer II
Shire Pharmaceuticals
05.2016 - 07.2016
Engineer I
Regeneron Pharmaceuticals
09.2015 - 05.2016
Engineer I
Moderna Therapeutics
06.2015 - 09.2015
Quality Engineer
ExterNetworks
10.2014 - 06.2015
Validation Engineer
GR Validation and Compliance
11.2013 - 08.2014
MS - Pharmaceutical Manufacturing
Stevens Institute of Technology
BS - Chemical Biology
Stevens Institute of Technology
MS - Management
University of Illinois Urbana-Champaign
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