プロフィール詳細

プロジェクトを作成

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Sukanya C.に依頼

United States

Scientific and Technical writing/ Downstream Protein Purification (10+ years) /GLP and cGMP compliance

プロフィール概要

• Proficient at downstream process development activities, experimental design and execution for viral vector and other drug substance purification. Make detailed observations and perform data analysis and interpretation. Knowledge of scale-up/scale-down principles to and from GMP to lab-scale setup. • Technical reports, Protocol, Statement of Work, batch record generation in a GDP compliant manner. • Knowledgeable about current and emerging regulatory strategies (cGMP and GLP) from FDA, EMEA and ICH guidelines (specifically Q5A, Q5C & Q7). Working knowledge of regulatory requirement of drug development and ISO 9001 requirements • Liaise with client project leads for study design coordination and hands on execution of viral clearance validation studies, column lifetime, virus and Drug Substance filter reprocessing, and resin storage and sanitization antimicrobial efficacy. • SME on AKTA chromatographic operations (Affinity, IEX, HIC, mixed mode), Unicorn method authoring. Experience in execution of Tangential Flow Filtration, Depth/Clarification filtration, VRF operation. • Hands-on experience in various laboratory analytical assay techniques (qPCR, TCID50, Plaque, Transduction Unit determination, Spectrophotometry) • High Throughput and one-off DNA engineering Cloning (LIC and Gateway). • In depth root cause analysis and non-conformances and deviation investigation; change control implementation.

専門分野

• ☆ Microbiology
• ☆ Virology
• ☆ Adenoviruses
• ☆ Microbiological Assays
• ☆ Bacteriology
• ☆ Gram-Positive Bacteria
• ☆ Biochemistry
• ☆ Immunoassay
• ☆ Biochemical Assays
• ☆ Structural Biology
• ☆ Molecular Biology
• ☆ Genetics
• ☆ PCR
• ☆ Molecular Cloning
• ☆ Next Generation Sequencing (NGS)
• ☆ Synthetic Genomics
• ☆ Recombinant DNA
• ☆ Cell Biology
• ☆ Cell-Based Assays
• ☆ Biotechnology & Bioengineering
• ☆ Recombinant Protein Expression
• ☆ Cell Culture
• ☆ Drug Discovery
• ☆ High Throughput Screening (HTS)
• ☆ Drug Development
• ☆ Biosafety Testing
• ☆ Bioanalytical Testing
• ☆ Drug Stability Testing
• ☆ Preclinical Research
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Vaccine Development
• ☆ Pharmaceutical Manufacturing
• ☆ Pharmaceutical Process Development
• ☆ Technical & Scientific Writing
• ☆ Scientific Proofreading & Editing

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Technical Writing, Creative Writing, General Proofreading & Editing, Translation

Research Feasibility Study, Scientific and Technical Research

Consulting Scientific and Technical Consulting, Manufacturing Consulting

Product Development Stability/Shelf Life Testing, Quality Assurance & Control (QA/QC)

職務経験

Staff Scientist

Advanced BioScience Laboratories

1月 2022 - 12月 2023

Scientist

MilliporeSigma

3月 2016 - 11月 2021

Research Scientist

Albert Einstein College of Medicine

9月 2010 - 6月 2014

学歴

M.S. in Biomedical Sciences (Biochemistry)

Hood College

1994 - 2000

認定資格

• 認定資格の詳細は未入力です。

出版物

JOURNAL ARTICLE

Sukanya Chowdhury (2013). Crystal structure of human Karyopherin β2 bound to the PY-NLS of Saccharomyces cerevisiae Nab2. Journal of Structural and Functional Genomics.