プロフィール詳細

プロジェクトを作成

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Renata F.に依頼

Brazil

Drug Product Formulation Expert

プロフィール概要

Professional Summary: Experienced professional with over 23 years in Formulation Drug Development, focusing on new products and post-registration processes. Expertise in developing various pharmaceutical dosage forms and molecules (small and peptides), including solids, sterile and non-sterile liquids, semi-solids, and combination products, covering everything from laboratory testing to scale-up and technology transfer. Technical and Management Skills: Leadership of multidisciplinary R&D teams, driving strategic projects for the development of innovative products. Cross-functional collaboration with interface areas, ensuring alignment and focus on common goals. Talent development and mentoring, fostering both professional and personal growth. Implementation of innovative technologies, from conceptualization to industrial application, utilizing methodologies such as Quality by Design (QbD). Management of innovation projects and industrial process optimization, enhancing productivity and reducing costs using tools such as Lean Manufacturing and Experimental Design (DoE). Expertise in the preparation of eCTD (Electronic Common Technical Document) for regulatory submissions. Experience in submissions and meeting regulatory requirements from agencies such as FDA, EMA, and Anvisa. Oversight of audits and third-party processes, including operations in Brazil and Germany. Academic Background and Additional Skills Degree in Pharmacy and Biochemistry from Unesp. MBA in Business Management from FGV. Advanced knowledge of English (writing, reading, and speaking).

専門分野

• ☆ Drug Development
• ☆ Drug Formulation
• ☆ Small Molecule Drug Development
• ☆ Biologic & Biosimilar Development
• ☆ Solid Form Screening
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Business & Legal Writing, Creative Writing

Research Market Research, Feasibility Study, Gap Analysis

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Digital Strategy Consulting, Healthcare Consulting, Legal Consulting, Operations Consulting

Data & AI Statistical Analysis

Product Development Formulation, Recipe Development, Deformulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing

職務経験

Universidade Estadual Paulista (Unesp)

3月 1998 - 現在

Formulation Coordinator

IVN

1月 2020 - 4月 2025

学歴

Bachelor of Science in Biochemistry, Molecular Biology and Biotechnology

UNESP

1月 1998 - 5月 2002

認定資格

• Certified Six Sigma Greenbelt

  NC Group

  1月 2025 - 現在

• Design of Experiments

  Protimiza

  1月 2025 - 現在