Greg Randall Email & Phone Number

Camarillo, Ca, Us

Waltham, Ma, Us

Building a Quality Lifecycle approach into our CDMO services for plasmid, cell therapy and mRNA at Thermo Fisher Scientific

Santa Monica, California, Us

Global MSAT support of the retroviral vector transfer and comparability protocol design review and execution.

Tuebingen, De

Walnut Creek, California, Us

Waltham, Ma, Us

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.

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

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

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.

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

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

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

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

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

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

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

Bsc. Mathematics, Mathematics/ Chemistry

Bachelors Of Science, Mathematics