Robyn Garcia

Robyn Garcia Email and Phone Number

Technical and Medical Writing Consultant at Tocagen Inc. @
Robyn Garcia's Location
San Diego, California, United States, United States
Robyn Garcia's Contact Details

Robyn Garcia personal email

n/a
About Robyn Garcia

Biotechnology professional with over 20 years of experience currently transitioning broad background across clinical trials and CMC support in an FDA-regulated environment into a role dedicated to medical writing. Greatest personal strengths include high degree of self-motivation and focus, excellent problem-solving and analytical capabilities, effective organization and planning skills, and exceptional attention to detail.

Robyn Garcia's Current Company Details
Tocagen Inc.

Tocagen Inc.

Technical and Medical Writing Consultant at Tocagen Inc.
Robyn Garcia Work Experience Details
  • Tocagen Inc.
    Technical And Medical Writing Consultant
    Tocagen Inc. Feb 2019 - Present
    Current role actively engages with Quality Assurance, Regulatory Affairs, Clinical Operations, and Clinical Development to author, co-author, review, and edit Standard Operating Procedures (SOPs), work process documents, and pharmacy manuals. Additional responsibilities within medical writing functional area include document/data reconciliation and QC for a variety of clinical and regulatory documents in support of clinical trial operations, protocol development, and CSR compilation.
  • Tocagen Inc.
    Associate Director, Quality Control
    Tocagen Inc. May 2012 - Present
    Responsible for managing cell and molecular biology-based testing to support viral vector manufacturing process development, as well as characterization, release and stability testing of viral vectors and associated production banks. Core methodologies include real-time quantitative PCR, HPLC, and nanoparticle analysis.
  • Rmg Photography
    Owner
    Rmg Photography Oct 2008 - Present
    Fine art and documentary photography; emphasis in botanical subject matter.
  • Vala Sciences, Inc.
    Quality Assurance Manager
    Vala Sciences, Inc. Aug 2011 - May 2012
    Responsible for establishing Quality Systems to support Vala Science's High-Content Screening of chemical compounds as part of the EPA's ToxCast program.
  • Tocagen Inc.
    Process Development And Quality Consultant
    Tocagen Inc. Aug 2010 - Dec 2011
    Provided diverse support for Process Development, Cancer Biology, and In Vitro Diagnostics. Conducted experiments to develop a proprietary medium formulation for Toca 511 producer cell line and generated corresponding transduction titer data to aid in performance evaluation. Edited/authored preclinical standard operating procedures to create a Work Instruction library; established departmental training program. Provided organizational and technical writing support for preclinical study protocols and reports. Audited historical Quality Control records and provided recommendations regarding assay reference standard, control, and critical reagent management and stability evaluation.
  • Stemedica Cell Technologies
    Director, Quality Control
    Stemedica Cell Technologies Aug 2008 - Jul 2009
    On a temporary basis, and initially as the sole employee experienced in cGMP-compliance for Phase 1/2 clinical trials, assumed diverse responsibilities including direction of both Quality Assurance and Quality Control functions in the effort to transition a Research and Development-stage adult stem cell laboratory into a GMP-compliant Manufacturing Facility capable of achieving licensure by the California Food and Drug Branch. Accomplishments included developing a comprehensive Master Schedule to capture and track all Facility activities and documentation required to prepare for successful FDB licensing inspection, transitioning R&D-stage documentation into industry-standard SOPs for procedures, equipment, and test methods, and establishing a controlled document system, Good Documentation Practices, production record format and content guidelines, preventive maintenance and calibration programs for all GMP equipment, and an employee training program. Facility successfully licensed Summer of 2009.
  • Novarx
    Senior Analyst, Quality Control (Part-Time, Temp)
    Novarx Nov 2007 - Jul 2008
    Assumed a part-time, temporary position to enable three-quarter time community college course work. Position provided analytical and Quality Systems support during a period of absence of the department’s sole Senior Analyst.
  • Genzyme
    Manager, Quality Control, Gene Therapy Operations
    Genzyme Nov 2005 - May 2007
    Paris, France, Fr
    Following Genzyme’s acquisition of the Cell Genesys viral vector manufacturing facility, maintained responsibility for managing immunological, cell, and molecular biology-based testing to support characterization, release and stability testing of viral vectors and associated production banks. Supervised a staff of five Analysts, a Laboratory Assistant, and a Quality Control Lab Coordinator.
  • Cell Genesys, Inc.
    Manager, Supervisor, Senior Analyst, Quality Control
    Cell Genesys, Inc. Jan 2001 - Nov 2005
    Hayward, Ca, Us
    Following acquisition of Chiron’s Center for Gene Therapy by Cell Genesys, attained increasing levels of responsibility and ultimately assumed responsibility for training and supervision of seven Quality Control staff. Coordinated in-house and contract testing of manufacturing and process development test articles. Served as Quality Control representative on viral vector project teams. Managed GMP PCR testing facility. Collaborated with Quality colleagues at corporate and remote locations on Quality Systems development including analyst training and qualification, assay transfer, and contract testing facility qualification. Authored and revised test method, procedure, and policy Standard Operating Procedures.
  • Chiron Corporation
    Specialist I, Analyst Iii, Quality Control, Center For Gene Therapy
    Chiron Corporation Jan 1998 - Jan 2001
    Emeryville, California, Us
  • Immusol, Inc.
    Research Associate I, Assay Development
    Immusol, Inc. Aug 1995 - Jul 1997
    Us
  • San Diego State University Foundation
    Research Associate, Biology
    San Diego State University Foundation 1993 - 1995
  • Immunopharmaceutics, Inc.
    Laboratory Technician Ii, Molecular Biology; Laboratory Technician I, In Vivo Laboratory
    Immunopharmaceutics, Inc. Aug 1990 - Aug 1993
  • San Diego Natural History Museum
    Curatorial Assistant, Herpetology
    San Diego Natural History Museum Sep 1981 - Apr 1990
    San Diego, Ca, Us

Robyn Garcia Skills

Gmp Biotechnology Validation Assay Development Molecular Biology Sop Quality System Quality Assurance Pcr Quality Control Cell Fda Laboratory Cell Culture Aseptic Processing Hplc Glp

Robyn Garcia Education Details

  • San Diego City College
    San Diego City College
    Photography
  • San Diego State University
    San Diego State University
    Emphasis In Systematics And Evolution

Frequently Asked Questions about Robyn Garcia

What company does Robyn Garcia work for?

Robyn Garcia works for Tocagen Inc.

What is Robyn Garcia's role at the current company?

Robyn Garcia's current role is Technical and Medical Writing Consultant at Tocagen Inc..

What is Robyn Garcia's email address?

Robyn Garcia's email address is ro****@****cox.net

What schools did Robyn Garcia attend?

Robyn Garcia attended San Diego City College, San Diego State University.

What are some of Robyn Garcia's interests?

Robyn Garcia has interest in Animal Welfare.

What skills is Robyn Garcia known for?

Robyn Garcia has skills like Gmp, Biotechnology, Validation, Assay Development, Molecular Biology, Sop, Quality System, Quality Assurance, Pcr, Quality Control, Cell, Fda.

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