Erik Mena

Senior Development Manager, Viral Vector MSAT at CCRM
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Contact Information
us****@****om
(386) 825-5501
Location
CA
Languages
  • Espagnol Native or bilingual proficiency
  • Français Native or bilingual proficiency
  • Anglais Native or bilingual proficiency
  • Italien Full professional proficiency
  • Romanian Professional working proficiency

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Experience

    • Biotechnology Research
    • 100 - 200 Employee
    • Senior Development Manager, Viral Vector MSAT
      • Sep 2022 - Present

    • Supervisor, Manufacturing - Upstream
      • Apr 2021 - Sep 2022

      • Starting-up of BMC manufacturing department • Recruitment orientation and personnel technical training for cGMP vaccine manufacturing processes • Development and implementation of GMP manufacturing processes for biological products • Use of single-use bioreactors (up to 2000L) to grow cells in specific settings for cell seeding, inoculum preparation, cell infection , continuous centrifugation and product clarification ensuring • and preparation) and to ensure intended biological product • Undertake manufacturing process technology transfer; and interact with internal BMC manufacturing teams • Supervision on upstream cell culture activities according sponsor processes • Managing manufacturing schedules in USP manufacturing areas, such as facility maintenance shutdowns, equipment qualifications, calibrations, and preventive and curative maintenance • Writing and managing all GMP documents related to manufacture (preparation and review of batch record, review of executed batch record, review of technology transfer documents, writing of risk assessments) • Lead data driven continuous improvement initiatives to identify key issues or losses, and collaborates with appropriate department to implement permanent corrective actions • Assisting with operating and capital budget preparation, monitoring, and execution • Inventory Forecasting to ensure safety consumable stock levels • Recruiting, onboarding and staff training for cGMP the manufacturing unit • Initiates and fosters good communication and cooperation between departments • Leads the team to support equipment GMP qualification (CQV) Show less

  • C3i /CETC
    • Montreal, Canada Area
    • Biomanufacturing Lead
      • Apr 2018 - Apr 2021

      • Starting-up of the new “BioTherapeutics & Vectors unit” at C3i • Management of a team of specialists in cGMP biomanufacturing and process development • Supervision technology transfer, translation and cGMP manufacture from the research lab to cGMP manufacture • Provide continuous staff support and training for cGMP suspension and adherent cell banking and viral vector manufacturing process and activities • Responsible for manufacturing planning tasks, including manufacturing specialist schedules, reagents and single-use consumables ordering • Responsible for planning the maintenance of equipment used in the cGMP viral vector manufacture and cell banking • Creation of cost estimation models for biomanufacturing projects • Responsible for budget planning • Planning and implementation of data collection tools and/or systems used before, during and after cGMP manufacture • Data collection and analysis for process continuous improvement • Hands-on in technology transfer, translation and cGMP cell culture and viral vectors manufacture in Upstream process (UPS) and downstream process (DSP) using single-use technology • Deep knowledge of using and selecting manufacturing equipment, reagents and raw materials to be used during cGMP manufacture • Execution of batch records according to cGMP standards • Drafting and review technical documents, including commissioning and qualification documents, validation procedures, standard operating procedures (SOPs), batch records and reports • Interface between Quality assurance (QA), quality control (QC), Regulatory Affairs (RA) and CETC facility engineering departments • Identification and resolution of any problem that may affect the efficient operation and quality standards of the ongoing projects Show less

    • Development Specialist in Human Immunotherapy
      • Jan 2018 - Apr 2018

      • Development/translation of new technologies for the production of human cell immunotherapies • Development and execution of state of the art bioprocesses tests and methods • Production and expasion of stem cells and cell immunotherapies for projects managed by the Cancer Immunotherapy Commercialization Center. (C3i) • Use of cellular, molecular, biochemical and other state of the art tools • Selection, culture, expansion of human stem cells under GMP regulations • Identification and resolution of any problem that may affect the efficient operation and quality standards of the ongoing projects • Plan the implementation and administration of data collection tools or systems. • Improve or adapt already existing methods • Documentation production (SOP’s forms, study plan and reports) Show less

    • Canada
    • Research Services
    • 1 - 100 Employee
    • Research Associate/Cell Culture specialist
      • Mar 2016 - Feb 2018

      Supervision of personnel in cell culture Develop/Perform ligand-binding assays (ELISA-RIA) Perform cytometry assays/analisys Maintenance and inventory for cell culture Cell production/delivery for specific studies including specific requirements Perform Microscopy in charge of mycoplasm testing platform Develop and write experimental protocols Data analyze and interpretation SOP production Periodic maintenance of laboratory equipment/ Inventory organization Any activity to set-up and maintain the laboratory in a GLP environment Administrative duties Report production Background literature searches Participation in RS&DE and CRO projects Ensuring the cleanliness of the laboratory pro-actively Show less

    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Immunochemistry Analyst
      • Jun 2013 - May 2015

      • Drug target discovery and preclinical services • Develop, perform and validation • Design and execute bioanalytical methods • Accomplish extraction of DNA-RNA • Perform ELISA/ flow cytometry/ qPCR assays • Expression and quantification of genes and proteins • Develop and write experimental protocols • Data analyse and interpretation • SOP and GLP • Clean, calibration and equipment maintenance Realisations; Key element working as part of a big team around the world, contributing with important ideas to drug test and drug discovery. Successfully develop and improve ELISA, PCR, DNA/RNA extraction procedures. Show less

    • M. Sc. Intern.Institute for Research in Immunology and Cancer, (IRIC)
      • 2011 - 2013

      •Design, execute and interpret experiments in the analysis of the spindle assembly checkpoint dynamics in germinal stem cells •Discover the genetic/genomic relationship between; cell niche, stem cells and cancer •Plasmid construction •Create transgenic worms (C.elegans) expressing fluorescent proteins •DNA-RNA tissue/cell extraction •Sequencing, siRNA, RT-PCR, •Cloning, transfection, recombinant expression vectors and worm micro-injection •Develop and improve experimental procedures •Clean, calibration and equipment maintenance Realisations; Track cell mitosis in vivo in the worm C.elegans germinal stem cells by confocal microscopy. Conceptualized, developed and launched a research project with potential application in medicine. Gaining a comprehensive understanding of the cellular mechanisms, genetics and genomics of stem cells and their potential applications against cancer. Show less

    • Mexico
    • Food and Beverage Services
    • 700 & Above Employee
    • Research assistant
      • 2007 - 2008

      •Search the molecules and genes that give taste to fruits •PCR and sequencing •Plasmid construction •Develop procedures and plant fast growing techniques •Clean and equipment maintenance Realisations Obtaining mango taste and 15% increase in sales of soft drink Mundet® •Search the molecules and genes that give taste to fruits •PCR and sequencing •Plasmid construction •Develop procedures and plant fast growing techniques •Clean and equipment maintenance Realisations Obtaining mango taste and 15% increase in sales of soft drink Mundet®

    • IT Services and IT Consulting
    • 700 & Above Employee
    • Associate research Scientist in Molecular biology
      • 2006 - 2007

      •Receive samples and perform molecular test (RT-PCR, PCR and sequencing) •Examine tissue and determine the stage of cancer by immunohistochemistry/ELISA •Develop a method of early molecular diagnostics and molecular prevention of breast cancer among Mexican women Realisations; Molecular marker for the early molecular diagnostics of breast cancer in Mexican women. National Award "Diploma in Scientific Research, Mexico 2006"​ with research "normalization of quantitative RT-PCR to analyze the expression of oestrogen receptors in the breast tissue." Show less

Education

  • Université de Montréal
    Master of Science (M.Sc.), Molecular Biology
    2011 - 2013
  • Universidad Autónoma Metropolitana
    Bachelor's degree, Experimental biology
    2002 - 2007
  • Universidad de la Ciudad de México
    Diploma, Genome Sciences/ psychopharmacogenomics
    2005 - 2006

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