Agnieszka R.

Analytical Development Specialist @ GRUPO NC

About

Professional with over 15 years of experience in Research and Development, Quality Control and Regulatory Affairs, working in highly regulated environments within the pharmaceutical, biotechnology and food and beverage industries. Experience in technical project coordination, timeline management, critical scientific data assessment, and interface with cross-functional teams and international partners. Strategic involvement in the technical and regulatory assessment of biological drug dossiers, including registration and post-approval lifecycle management with ANVISA, with a focus on technical and regulatory gap analysis, risk mitigation strategy definition, and technical support for decision-making. Technical background in analytical development, stability-indicating methodologies, forced degradation studies, degradation product assessment, and critical interpretation of analytical data. PhD in Sciences, with a granted patent and peer-reviewed international publications.

Country

Brazil

City

Jundiaí

Industry

Pharmaceuticals

Skill

Critical Data Interpretation, Literature Reviews, R&D Project Coordination, Forced degradation, Software Zeneth, Research and Development (R&D), Degradation Products, Stability Studies, Technical Dossier Evaluation, Drug Registration and Post-Approval Activities, Risk Mitigation Strategy, International Meetings, Third-Party Scouting and Evaluation, Technical and Regulatory Risk Management, Identification of Technical Gaps, Schedule Planning and Control, Technical Decision-Making, Technical Negotiation, ANVISA, Project Coordination

Experience

Analytical Development Specialist

GRUPO NC

2026-4 - Present · 6 mos

Hortolândia, SP

Rio Biofarma Brasil Ltda - Tides Synthesis Laboratory

Biological Products R&D Specialist

Brainfarma

2022-4 - 2026-4 · 4 yrs 1 mo

Jundiaí, SP

• Technical coordination in the assessment of biological drug dossiers for registration and post-approval changes with ANVISA (RDC 55, 166, 412, 53, 964, 413 and IN 65). • Identification of technical and regulatory gaps and definition of risk mitigation strategies. • Planning and prioritization of activities to ensure regulatory timelines and project milestones are met. • Preparation and review of technical reports, scientific assessments, and regulatory documentation. • Scientific evaluation of analytical methods, specifications, and stability data. • Technical interface and negotiation with international partners and third-party manufacturers.

Senior Analytical Development Analyst

Brainfarma

2018-6 - 2022-4 · 3 yrs 11 mos

Barueri, São Paulo

• Development, optimization, and evaluation of analytical methodologies, with a strong focus on HPLC. • Execution of forced degradation and compatibility studies. • Development of stability-indicating methods to support regulatory submissions. • Preparation of technical analytical reports in compliance with regulatory requirements. • Operation in accordance with Good Laboratory Practices (GLP), ensuring data integrity and traceability.

Researcher

Institute of Chemistry - University of Sao Paulo

2017-9 - 2018-5 · 9 mos

Greater São Paulo Area

• Development of recombinant protein expression systems (E. coli and Saccharomyces cerevisiae). • Application of molecular biology techniques and electron microscopy.

R&D Coordinator

Instituto Butantan

2016-11 - 2017-7 · 9 mos

São Paulo

• Technical and scientific contribution to industrial vaccine development and innovation projects. • Development and optimization of methodologies applied to vaccine production processes. • Technical support to project decision-making and monitoring of deliverables.

PhD Researcher

USP - Universidade de São Paulo

2012-2 - 2016-2 · 4 yrs 1 mo

Greater São Paulo Area

Ph.D Researcher at School of Pharmaceutical Sciences, University of Sao Paulo.

R&D Chemist

Botanix - BarthHaas Group

2009-8 - 2010-10 · 1 yr 3 mos

Paddock Wood, Kent, United Kingdom

Botanix Ltd • Participation in innovation and product development projects. • Development and optimization of formulations, contributing directly to the company’s patent portfolio. • Application of supercritical CO₂ extraction technology to obtain botanical extracts for the food, pharmaceutical, and cosmetic industries.

Analytical Chemist

Botanix - BarthHaas Group

2006-9 - 2009-8 · 3 yrs

Paddock Wood, Kent, United Kingdom

Botanix Ltd • Execution of quality control and analytical services for raw materials, essential oils and finished products. • Operation and interpretation of results using HPLC, GC, GC-MS, UV-Vis, and FT-IR techniques.