OVERVIEW
FOCUS AREAS
EXPERIENCE
– Cellular and viral gene therapy development, manufacturing, and commercialization
-Hematology/Oncology research
– Regulatory Strategy and CMC oversight
– Quality Management Systems
– Pre-License, cGMP Surveillance Inspections for Biologics
– Human cells, tissues, and tissue-based products, ADCs
– Facility/Supplier Requirements
– Lead quality and regulatory functions in support of four of the first nine gene therapy market authorizations
– Head of Quality of premier contract development and manufacturing site with responsibility for quality assurance, quality control, and regulatory compliance.
Natika brings valuable expertise in cellular and viral gene therapy products, biological APIs, human tissue-based products, and antibody-drug conjugates. Her career highlights include site leadership of quality and regulatory functions in support of four gene therapy market authorizations since 2017. She has hosted numerous successful global CGT/ATMP inspections and brings clients a unique depth of knowledge and demonstrated end to end experience.
Natika is a Principal Consultant focused on biologics from pre-IND through commercialization, including CMC oversight, gap assessments, cGMP manufacturing and quality, aseptic processing, inspections, advocacy, and surveillance.
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EDUCATION:
M.S. in Biology (Molecular Cell Science), University of Memphis, Memphis, TN
B.S. in Biology, University of California, San Diego, CA
Certificate Biotech Enterprise Management – Owen Graduate School of Management, Vanderbilt University, Nashville, TN
CERTIFICATIONS:
Certified Quality Auditor (ASQ-CQA) – American Society for Quality
Certified Tissue Banking Specialist (CTBS) – American Association of Tissue Banks (AATB)
Continuing Education (CE) Provider – California Department of Registered Nursing
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