プロフィール詳細

プロジェクトを作成

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Dr. Adrian S.に依頼

Brazil

Biochemistry PhD | Regulatory & Technical Writer for IVD, Biotech & Life Sciences | ISO 13485 | QbD

プロフィール概要

Biochemist with a PhD (UFPR/Universität Tübingen) and 10+ years at the intersection of biotechnology R&D, regulatory affairs, and quality management. Currently leading technological development of biotechnological inputs at IBMP, a nonprofit research institute in Brazil focused on IVD and biopharmaceuticals. My day-to-day work spans the full product development pipeline — from early-stage research (recombinant proteins, nucleic acid synthesis, antibody development) through regulatory submissions (ANVISA) and quality system documentation aligned with ISO 13485 and ICH Q8/Q9/Q10 (QbD). I also hold an MBA in Project Management (USP/ESALQ), which informs how I structure technical deliverables for both scientific and business audiences. Services I offer as a freelance expert include regulatory and technical writing (dossiers, SOPs, validation reports, technical documentation for IVD/biotech), scientific consulting on product development strategy, and literature reviews. I bring a rare combination: I understand the science, the regulatory pathway, and the business context — so my writing doesn't just describe results, it builds the case your submission needs.

専門分野

• ☆ Biochemistry
• ☆ Biochemical Assays
• ☆ Molecular Biology
• ☆ Genetics
• ☆ PCR
• ☆ Molecular Cloning
• ☆ Protein Sequencing
• ☆ Recombinant DNA
• ☆ Oligonucleotide Synthesis
• ☆ Plasmid DNA
• ☆ Monoclonal Antibody Production
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Technical & Scientific Writing
• ☆ SOP & Protocol Writing

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Medical Writing, Non-Medical Regulatory Writing, Technical Writing

Research Market Research, Gap Analysis

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Healthcare Consulting, Scientific and Technical Consulting, Financial Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Formulation, Recipe Development, Deformulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC)

職務経験

Coordinator of Technological Development Biotechnological Inputs

IBMP Instituto de Biologia Molecular do Parana

9月 2024 - 現在

Researcher, IVD Product Development

IBMP Instituto de Biologia Molecular do Paraná

4月 2024 - 9月 2024

Technical Support Specialist, IVD (SAC)

IBMP Instituto de Biologia Molecular do Paraná

4月 2022 - 4月 2024

Supervisor, COVID-19 Support Laboratory

IBMP Instituto de Biologia Molecular do Paraná

6月 2020 - 4月 2022

Visiting Research Fellow, Tübingen

Eberhard Karls Universität Tübingen

1月 2018 - 10月 2019

学歴

PhD student

Eberhard Karls Universität Tübingen

4月 2018 - 5月 2020

Doctor in Sciences - Biochemistry (Biochemistry)

Universidade Federal do Paraná

5月 2016 - 5月 2020

Master in Sciences - Biochemistry (Biochemistry)

Universidade Federal do Paraná

4月 2014 - 3月 2016

Undergraduate (Biology)

Universidade Estadual de Ponta Grossa

2月 2010 - 2月 2014

認定資格

• MBA em Gestão de Projetos

  USP/ESALQ

  1月 2022 - 現在

出版物

PREPRINT

Luciano Fernandes Huergo, Marcelo Santos Conzentino, Edileusa Cristina Marques Gerhardt, Adrian Richard Schenberger Santos, Fabio Oliveira Pedrosa, Emanuel Maltempi Souza, Meri Bordignon Nogueira, Karl Forchhammer, Fabiane Gomes Moraes Rego, Sônia Mara Raboni, et al. (2020). Magnetic bead-based ELISA allow inexpensive, rapid and quantitative detection of human antibodies against SARS-CoV-2 .

JOURNAL ARTICLE

Adrian Richard Schenberger Santos, Edileusa Cristina Marques Gerhardt, Erick Parize, Fabio Oliveira Pedrosa, Maria Berenice Reynaud Steffens, Leda Satie Chubatsu, Emanuel Maltempi Souza, Luciane Maria Pereira Passaglia, Fernando Hayashi Sant'Anna, Gustavo Antônio de Souza, et al. (2020). NAD+ biosynthesis in bacteria is controlled by global carbon/nitrogen levels via PII signaling . Journal of Biological Chemistry.

Adrian Richard Schenberger Santos, Edileusa Cristina Marques Gerhardt, Vivian Rotuno Moure, Fábio Oliveira Pedrosa, Emanuel Maltempi Souza, Riccardo Diamanti, Martin Högbom, Luciano Fernandes Huergo(2018). Kinetics and structural features of dimeric glutamine-dependent bacterial NAD+synthetases suggest evolutionary adaptation to available metabolites . Journal of Biological Chemistry. 293. (19). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 7397--7407. American Society for Biochemistry {\&} Molecular Biology ({ASBMB})

Santos, K.F.D.N., Moure, V.R., Hauer, V., Santos, A.R.S., Donatti, L., Galvão, C.W., Pedrosa, F.O., Souza, E.M., Wassem, R., Steffens, M.B.R.(2017). Wheat colonization by an Azospirillum brasilense ammonium-excreting strain reveals upregulation of nitrogenase and superior plant growth promotion . Plant and Soil. 415. (1-2). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 245-255.

Santos, A.R.S., Etto, R.M., Furmam, R.W., Freitas, D.L.D., Santos, K.F.D.N., Souza, E.M.D., Pedrosa, F.D.O., Ayub, R.A., Steffens, M.B.R., Galvão, C.W.(2017). Labeled Azospirillum brasilense wild type and excretion-ammonium strains in association with barley roots . Plant Physiology and Biochemistry. 118. Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 422-426.

Laskoski, K., Santos, A.R.S., Bonatto, A.C., Pedrosa, F.O., Souza, E.M., Huergo, L.F.(2016). In vitro characterization of the NAD⁺ synthetase NadE1 from Herbaspirillum seropedicae . Archives of Microbiology. 198. (4). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 307-313.