Greg Randall

Greg Randall Email and Phone Number

Principal Consultant @ GCRandall Consulting LLC
Camarillo, CA, US
Greg Randall's Location
Camarillo, California, United States, United States
Greg Randall's Contact Details
About Greg Randall

Over 20 years of leadership experience in pre-clinical, fine chemical, API and Biotechnology manufacturing experience. Demonstrated leadership in cGMP strategy for new and existing facilities. Design quality systems interelationship to multi disciplinary functions. Contributor to industry councils and standards for validation. Excellent problem analysis and solving ability. Demonstrated commitment and integrity with a sense of urgency for the success of the business. Assist companies with process validation, quality assurance ,monitoring , risk management, technology transfer , scale-up and Quality by Design (QbD) activities and documentation.Specialties: Validation, risk management, Quality by Design,PAT, filter validation, sterilization, Lean, six sigma and Operational Excellence activities

Greg Randall's Current Company Details
GCRandall Consulting LLC

Gcrandall Consulting Llc

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Principal Consultant
Camarillo, CA, US
Greg Randall Work Experience Details
  • Gcrandall Consulting Llc
    Principal Consultant
    Gcrandall Consulting Llc
    Camarillo, Ca, Us
  • Thermo Fisher Scientific
    Site Head Of Quality
    Thermo Fisher Scientific Mar 2022 - Present
    Waltham, Ma, Us
    Building a Quality Lifecycle approach into our CDMO services for plasmid, cell therapy and mRNA at Thermo Fisher Scientific
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  • Kite Pharma
    Msat Consultant
    Kite Pharma Apr 2021 - Mar 2022
    Santa Monica, California, Us
    Global MSAT support of the retroviral vector transfer and comparability protocol design review and execution.
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  • Immatics
    Senior Consultant
    Immatics Jun 2020 - Mar 2022
    Tuebingen, De
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  • Dark Horse Consulting Group Inc.
    Senior Consultant
    Dark Horse Consulting Group Inc. Feb 2020 - Mar 2022
    Walnut Creek, California, Us
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  • Thermo Fisher Scientific
    Consultant
    Thermo Fisher Scientific Sep 2021 - Jan 2022
    Waltham, Ma, Us
    View
  • Adaptimmune
    Process Validation Consultant
    Adaptimmune Mar 2020 - Oct 2021
    Abingdon, Oxfordshire, Gb
    Performed Process and Raw Material risk Assessment to drive development of identified CQA’s , MBRs requirements and electronic batch record critical parameters development, verification and reporting for process design and qualification.
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  • Validant
    Pai Biosimiliar Consultant
    Validant Oct 2019 - Nov 2019
    San Francisco, Ca, Us
    Performed audit of Quality Assurance, Manufacturing Production and Process Controls, Management and Material Controls to assess GMP and PAI readiness, Assessed IQ/OQ/PQ and validation protocols. Reviewed and assessed deviations, non-conformances, change controls and CAPA’s
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  • Atara Biotherapeutics
    Biotech/Pharma/Gene Therapy Consultant At Atara Biotherapeutics
    Atara Biotherapeutics Oct 2018 - Sep 2019
    Thousand Oaks, Ca, Us
    Process validation Design and Performance Qualification for an Allogeneic T-Cell Immunotherapy. Tracking and Trending of Key and Critical Parameters, Media Simulation and PPQ training. Perform Deviation/Exception reports, CAPA, Risk Assessments and mitigation
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  • Beacon Hill Pharma
    Biotech/Pharma/Gene Therapy Consultant At Avexis
    Beacon Hill Pharma Mar 2017 - Aug 2018
    Process validation, Quality Assurance start-up activities for Gene Therapy Company. Support and perform commissioning (FAT, URS, FRS, technical specifications), and qualification (IQ, OQ, PQ) of new process (single-use) and lab equipment (pumps, bioreactors, centrifuges, (UF/DF, TFF, chromatography, columns, fillers, hood, BSC, mixers, cold storage, tube welders and sealers) of biotech based GMP manufacturing operations.
  • Shire
    Technology Transfer Manager
    Shire Jan 2010 - Dec 2016
    Tokyo, Jp, Jp
    Responsible for Technology Transfer of Validated processesMaterial Qualification, Cleaning Validation, Shipping Validation, Process Validation ActivitiesDevelopment of Cleaning Validation monitoring and trending with a QBD relationship embedded, Development of Global Quality Standard, Process Study design, Failure investigation/non conformance reporting review board
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  • Boehringer Ingelheim
    Manager, Process Validation
    Boehringer Ingelheim Oct 2009 - Jan 2010
    Ingelheim Am Rhein, Rhineland-Palatinate, De
    Draft Validation Master PlanExecute Program Risk AssessmentDevelop and Presented Risk Mitigation PlanResponsible for Fill/Finish Cleaning and sterilization validation masterplan
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  • Amgen
    Corporate Qa Validation- Principal Validation Engineer
    Amgen Jun 2003 - Jul 2009
    Thousand Oaks, Ca, Us
    Perfomed risk assesments on global Validation (cleaning, process and sterilization) processes- PHA, FMEA etc.Developed and maintained corporate Validation cycle time metricsDeveloped a global characterization, validation, in-process control and maintenance/monitoring cleaing (CVIM) programDeveloped Global Corporate Validation Operating StandardsImplemented Corporate Quality Validation systemDeveloped global filter validation program for all commerical and clinical productsDeveloped and implemented cleaning and Sterilization Validation protocols, master plans and acceptance criteria for new biopharmaceutical manufacturing facility in Puerto Rico and Rhode Islanddesgined and implemented cost saving off $240,000/yr saving for tech transfer of bioburden analytical release testing
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  • Pfizer
    Manager Cleaning Validation
    Pfizer Jan 2000 - Jun 2003
    New York, New York, Us
    • Responsible for managing and accelerating the current cleaning validation program (currently over 150 API’s and 600 total products). • Written and implemented over, 25 cleaning validation protocols, 250 cleaning records and reviewed the development and validation of 200 cleaning verification assay transfers• Administrative responsibilities include developing SOP’s; writing protocols, identifying and staffing requirements• Develop program-tracking mechanisms for multiple product work centers. • Technical responsibilities include defining limits calculations, analytical development / validation requirements, failure investigation, assay transfer, approving cleaning records, and facilitating ongoing training. • Managed eight cleaning validation analytical and quality staff responsible for equipment qualification, cleaning process validation and monitoring/maintenance
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  • Pfizer
    Quality Assurance Representative
    Pfizer Aug 1999 - Mar 2000
    New York, New York, Us
    • Primary contact for quality issues for Two manufacturing Operating Units. • Assess deviation for potential product impact and final reviewer and approver of Deviation Investigation, Change Control, Corrective action and Preventative actions(CAPA)• Quality approver for batch record review and lot release
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  • Zeeland Chemical Co
    Associate Scientist
    Zeeland Chemical Co Apr 1997 - Aug 1999
    Associate Scientist• R & D analytical scientist responsible for all new product analytical specifications, stability indicating assays, in process test assays, product release assay, in addition to cleaning verification assays • Developed cleaning verification equipment release requirements, method transfer protocols along with raw material acceptance criteria• Developed and filed Drug Master File(DMF) for release and stability indicating assays
  • Mpi Research
    Manager Qc Lab
    Mpi Research 1988 - 1997
    Mattawan, Mi, Us
    MPI Reserach is a Non-clinical Contract Research Organization with primate and canine colonies, serving government agencies, pharmaceutical, consumer product, and medical device industries. August 1994 to August 1997 : MPI(formerly IRDC) Mattawan, MichiganSupervisor Bio-analytical Chemist•Managed four bio-analytical chemists which developed and validate assays in accordance to ICH guidelines in a pre-clinical environment• Evaluate, summarize and model pharmacokinetic studiesAugust 1988 to August 1994 : IRDC, Mattawan, MichiganAnalytical Chemist• Developed assays utilizing HPLC, GC, AA, and UV/Vis• Develop / validate methods for the determination of metabolites in biological matrices, inhalation chamber set up and particle size analysis, release testing for dietary, suspension, and solution mixtures• Performed Test diet wet release assays• Establish analytical release specification for test diets, solutions and suspensionStudy design for analytical sampling strategy for rodent, rabbits, and primates• Analyzed bone for trace metal analysis of Mg, Fe, and Mn
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Greg Randall Skills

Mathematics Venue Technical Reviews Chemical Corrective Actions Master Plan Method Transfer Units Shipping Chemistry Cost Clinical Research Biotechnology Change Control Filter U.s. Food And Drug Administration Successful Track Record Site Management Minitab Apis Deviations Cross Functional Team Leadership Sme Legal Facilitation Design Of Experiments Clinical Development Pda Assessment Fat Closure Trend Management Design Outsourcing Science Metrics 21 Cfr Part 11 Change Point Auditing Pfizer Technology In Process Lean Manufacturing Parenteral Equipment Qualification Hplc Qualification Seminars Gmp Networking Data Validation Process Validation Acceptance Testing Dmf Data Recovery Supplier Quality Project Leadership Validation Process Analysis Engineering Reports Cleaning Strategy Method Development Materials Testing V&v Risk Management Transportation Testing Drug Development Training Puerto Rico Trending Calculations News Plasma Physics Conferences Subject Matter Expert Operational Excellence Corrective And Preventive Action Documentation Informatics Quality Control Research System Monitoring Reporting Third Party Applications Commercial Real Estate Investigation Capa Lims Analysis Inspection Los Angeles Biopharmaceuticals Mechanisms Laboratory Sterilization .net Systems Design R Verizon Harmonization Gas Chromatography Coordination Fix Protocol Biotechnology Industry Applications Data Analysis Fmea Standard Operating Procedure High Performance Liquid Chromatography Quality Assurance Qc Cost Savings Global Engineering Characterization Quality By Design Author Quality System Analytical Chemistry Commercial Products Risk Assessment Power Bi Ohio Bioburden Sat Failure Analysis Remediation Data Driven Testing Verification And Validation Project Contractual Agreements Metric Facilities Management Business Process Mapping Technology Transfer Statistical Software Dmaic Responsibility Six Sigma Mass Production International Master Plans Reviews Ich Guidelines Fractionation Mpi Green Belt Guidelines Data Quality Cleaning Validation Medical Devices Wet Chemistry Compliance Limits Pharmaceutics Clutter Control Business Process Manufacturing China Stability Decision Making Aa Knowledge Management Risk Pharmaceutical Industry Filing Emea Analytical Method Validation Fda Acceptance Criteria Bioscience Gaps

Greg Randall Education Details

  • Western Illinois University
    Western Illinois University
    Mathematics/ Chemistry
  • Western Michigan University
    Western Michigan University
    Mathematics

Frequently Asked Questions about Greg Randall

What company does Greg Randall work for?

Greg Randall works for Gcrandall Consulting Llc

What is Greg Randall's role at the current company?

Greg Randall's current role is Principal Consultant.

What is Greg Randall's email address?

Greg Randall's email address is gd****@****zon.net

What is Greg Randall's direct phone number?

Greg Randall's direct phone number is +180544*****

What schools did Greg Randall attend?

Greg Randall attended Western Illinois University, Western Michigan University.

What are some of Greg Randall's interests?

Greg Randall has interest in Science And Technology, Environment.

What skills is Greg Randall known for?

Greg Randall has skills like Mathematics, Venue, Technical Reviews, Chemical, Corrective Actions, Master Plan, Method Transfer, Units, Shipping, Chemistry, Cost, Clinical Research.

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