プロフィール詳細

プロジェクトを作成

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☆☆☆☆☆

Rachel A.に依頼

United States

Cell Therapy MSAT & Tech Transfer Consultant – CAR-T, VSTs, GMP Manufacturing

プロフィール概要

I help cell therapy teams achieve operational success during scale-up and clinical manufacturing. -Tech transfer readiness + risk assessments -Troubleshooting low yield, viability, or assay variability -Flow cytometry panel design + gating review -SOPs, BRs, and GMP documentation alignment Experience: • ~25% improvement in CAR-T process reproducibility • Reduced contamination risk with workflow optimization • 50+ clinical GMP batches supported (CAR-T + EBV-specific T cells) Platforms: WAVE, LOVO, CliniMACS, Cytek Aurora, MACSQuant Compliance: FDA/EMA guidelines, ISO 5/7/8 cleanroom ops Let’s discuss your bottlenecks — together we’ll define a solution path. Cell Therapy Process & MSAT Consultant — Remote/Onsite NY/NJ I support cell therapy teams during process development and manufacturing scale-up by improving reproducibility, reducing contamination risk, and ensuring documentation readiness for GMP operations. Specialties • Autologous CAR-T & VST process troubleshooting (upstream optimization, aseptic operations) • Flow cytometry panel redesign and gating QC • Assay streamlining for faster clinical decision timelines • GMP-compliant documentation + risk assessments I bring a collaborative, analytical approach — and I hit the ground running.

専門分野

• ☆ Cell Biology
• ☆ Cell-Based Assays
• ☆ Cytochemistry
• ☆ Cytogenetics
• ☆ Cell Signaling Pathways
• ☆ Gene Regulation
• ☆ Stem Cell Research
• ☆ Basic Immunology
• ☆ Adjuvant & Antigen Research
• ☆ Biotechnology & Bioengineering
• ☆ Biomedical Engineering
• ☆ Industrial Engineering
• ☆ Manufacturing
• ☆ Lean Manufacturing
• ☆ Manufacturing Optimization
• ☆ Automation
• ☆ Manufacturing Automation
• ☆ Cell Culture
• ☆ Primary Cells
• ☆ Cell Banking
• ☆ Cell Line Engineering
• ☆ Large Scale Cell Culture
• ☆ Cell Surface Receptors
• ☆ Biomolecular Engineering
• ☆ Genetic Engineering
• ☆ Gene Editing/CRISPR
• ☆ Protein/Enzyme Engineering
• ☆ Antibody Engineering
• ☆ Gene Delivery
• ☆ Cytometry
• ☆ Cell Aging

サービス

• Writing

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Creative Writing, Newswriting, Audio Transcription, General Proofreading & Editing, Translation

職務経験

Columbia University

- 現在

Development Scientist

Minaris Regerative Medicine

1月 2020 - 現在

学歴

Bachelor of Science in Biological Sciences

Columbia University

9月 2012 - 5月 2015

認定資格

• 認定資格の詳細は未入力です。