Jim Marich

Jim Marich Email and Phone Number

Owner @ San Diego, CA, US
San Diego, CA, US
Jim Marich's Location
San Diego, California, United States, United States
Jim Marich's Contact Details

Jim Marich personal email

n/a
About Jim Marich

Experienced in the development and commercialization of human therapeutics. Focused on advancing new and existing products through sound scientific judgment and regulatory acumen. Thorough background in the creation, improvement and execution of quality systems. Strong regulatory CMC knowledge for biologics including proteins, antibodies, gene and cell therapies. A history of achievement in the development of pharmaceutical products. Operations experience includes:Quality Systems • Validation • Quality Assurance • Quality Control • Product and Method DevelopmentSpecialties: US FDA/EMA/ICH Regulatory Compliance, GMP /GLP Regulations, Quality System Gap Analysis, Biologics and Small Molecule Manufacturing Quality, API, Parenteral and Aseptic Processing Quality, Supplier Auditing and Qualification, Quality Agreements, Product Release (Master Batch Record and Specification Development, Batch Record and Test Method /C of A Review and Disposition), Deviations and Investigations, CAPA, Risk Assessment, Change Control, Internal Auditing, Training, Master Validation Plans, Equipment/Facility/Method Validation, Stability Testing, Method Development, Biological, Chemical and Microbiological Technical Expertise.

Jim Marich's Current Company Details
Marich and Associates, Inc.

Marich And Associates, Inc.

Owner
San Diego, CA, US
Jim Marich Work Experience Details
  • Marich And Associates, Inc.
    Owner
    Marich And Associates, Inc.
    San Diego, Ca, Us
  • Marich And Associates Consulting
    Owner
    Marich And Associates Consulting 2010 - Present
    Providing compliance review and oversight of quality systems, manufacturing, testing and validation for new and existing therapeutic products in the US and internationally. • Biologics manufacturing and development• GxP quality system gap analysis and remediation for drug manufacturing operations.• Pharmaceutical product quality assurance operations oversight• Development of specifications, production records, release and stability testing• Batch review and release of API and drug product• GMP and GLP auditing• Selection and oversight of contract API and drug product manufacturing operations • Validation master plans• Regulatory CMC authorship and review• US and European regulatory compliance
  • Genzyme Corporation
    Director, Quality
    Genzyme Corporation 2005 - 2010
    Site Quality Head. Led Quality Assurance, Validation and Quality Control functions in compliance with US and European pharmaceutical manufacturing regulations and standards. Manufactured and developed gene and protein therapeutics.
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  • Cell Genesys
    Director, Quality Control/Associate Director Quality Control
    Cell Genesys 2001 - 2005
    Led three integrated yet geographically distinct Quality Control operations located in Hayward CA, San Diego, CA and Memphis TN. Supervised groups conducting cellular/molecular biology, analytical chemistry and microbiology. Manufactured and developed gene therapeutics (AAV, adenovirus, and lentivirus), cell therapeutics and vaccines.
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  • Chiron Corporation
    Manager, Quality Control/Associate Manager Quality Control
    Chiron Corporation 1997 - 2001
    Managed a Quality Control group to support clinical evaluation of retroviral and adenoviral vectors and cell therapeutics.
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  • Immusol
    Manager, Assay Development
    Immusol 1995 - 1997
    Developed and managed the performance of analytical and biological test methods for AAV gene therapy vectors.
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  • Genta
    Research Scientist
    Genta 1992 - 1994
    Developed analytical methods and performed in vitro assessments of candidate antisense drugs.
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  • Molecular Biosystems Inc
    Research Scientist/Research Associate
    Molecular Biosystems Inc 1985 - 1991
    Conducted applied research, assay development, product development and manufacturing for nucleic acid based diagnostics.

Jim Marich Skills

Qualtiy Management Quality Systems Validation Method Developement And Validation Project Management International Contracting Biologics Manufacturing Cell Change Control Gmp Quality System Glp Capa Cross Functional Team Leadership Assay Development Manufacturing Microbiology Gxp Program Management Quality Assurance Biotechnology Biologics Clinical Trials Regulatory Requirements Quality Control Technology Transfer Sop Aseptic Processing Lifesciences Analytical Chemistry Life Sciences

Jim Marich Education Details

Frequently Asked Questions about Jim Marich

What company does Jim Marich work for?

Jim Marich works for Marich And Associates, Inc.

What is Jim Marich's role at the current company?

Jim Marich's current role is Owner.

What is Jim Marich's email address?

Jim Marich's email address is ji****@****cox.net

What schools did Jim Marich attend?

Jim Marich attended Texas A&m University, Cornell University.

What are some of Jim Marich's interests?

Jim Marich has interest in Jim Marich's Professional Interests.

What skills is Jim Marich known for?

Jim Marich has skills like Qualtiy Management, Quality Systems, Validation, Method Developement And Validation, Project Management, International Contracting, Biologics Manufacturing, Cell, Change Control, Gmp, Quality System, Glp.

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