Jim Marich Email & Phone Number
@cox.net
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Who is Jim Marich? Overview
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Jim Marich is listed as Owner at Marich and Associates, Inc., based in San Diego, California, United States. AeroLeads shows a work email signal at cox.net and a matched LinkedIn profile for Jim Marich.
Jim Marich previously worked as Owner at Marich And Associates Consulting and Director, Quality at Genzyme Corporation. Jim Marich holds M.S., Biochemistry from Texas A&M University.
Email format at Marich and Associates, Inc.
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AeroLeads found 1 current-domain work email signal for Jim Marich. Compare company email patterns before reaching out.
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.
Listed skills include Qualtiy Management, Quality Systems, Validation, Method Developement And Validation, and 27 others.
Jim Marich's current company
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Jim Marich work experience
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Owner
CurrentProviding 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
Director, Quality
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.
Director, Quality Control/Associate Director Quality Control
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.
Manager, Quality Control/Associate Manager Quality Control
Managed a Quality Control group to support clinical evaluation of retroviral and adenoviral vectors and cell therapeutics.
Manager, Assay Development
Developed and managed the performance of analytical and biological test methods for AAV gene therapy vectors.
Research Scientist
Developed analytical methods and performed in vitro assessments of candidate antisense drugs.
Research Scientist/Research Associate
Conducted applied research, assay development, product development and manufacturing for nucleic acid based diagnostics.
Jim Marich education
M.S., Biochemistry
A.B., Biology
Frequently asked questions about Jim Marich
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What company does Jim Marich work for?
Jim Marich works for Marich and Associates, Inc..
What is Jim Marich's role at Marich and Associates, Inc.?
Jim Marich is listed as Owner at Marich and Associates, Inc..
What is Jim Marich's email address?
AeroLeads has found 1 work email signal at @cox.net for Jim Marich at Marich and Associates, Inc..
Where is Jim Marich based?
Jim Marich is based in San Diego, California, United States while working with Marich and Associates, Inc..
What companies has Jim Marich worked for?
Jim Marich has worked for Marich And Associates, Inc., Marich And Associates Consulting, Genzyme Corporation, Cell Genesys, and Chiron Corporation.
How can I contact Jim Marich?
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What schools did Jim Marich attend?
Jim Marich holds M.S., Biochemistry from Texas A&M University.
What skills is Jim Marich known for?
Jim Marich is listed with skills including Qualtiy Management, Quality Systems, Validation, Method Developement And Validation, Project Management, International Contracting, Biologics Manufacturing, and Cell.
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