Daniela Barengo
Mazzè
Summary
Technical R&D Senior Expert Science and Technologies
Overview
8
8
years of professional experience
Work History
Technical R&D Senior Expert Science and Technologies
Advanced Accelerator Applications, a Novartis Comp
09.2023 - Current
- Lead the development of formulations and manufacturing process of Drug Product (parenteral sterile solution and lyophilized kit for radiopharmaceutical preparation)
- Participate to the transfer of analytical and manufacturing procedures to internal (Technical Operation) and external (CDMO, Radiopharmacy) sites
- Serve as line function representative in cross-functional project team and guide the internal discussions during the project alignment
- Execute high quality, integrated cross-functional plans for projects while adhering to budget, scope and schedule requirements throughout all phases of the project life cycle
- Be accountable for all formulation and manufacturing process deliverables including scientific documentation for all assigned project
- Draft the CMC documents required to enable regulatory submission (IND/IMPD, NDA) and guarantee technical support for Drug Product requests during Health Authority inspection
Technical R&D Scientist
Advanced Accelerator Applications, a Novartis Company
10.2020 - 08.2023
- Design, plan and perform experiments/activities for the development of formulations and manufacturing processes of new drug products
- Development and validation of analytical methods in accordance with ICH guidelines and with specific reference to quality control of radiopharmaceutical products
R&D Pharma Technologies Specialist
CID (Carbostent & Implantable Devices) member of Alvimedica
06.2018 - 09.2020
- Management of the chemical laboratory
- Development and validation of analytical methods
- Formulations development and identification of chemical / pharmaceutical technologies for the formulation integration on the final devices (Stent for PTCA)
- Audit participation as laboratory and pharma referee (TUV SUD, ISS, TGA).
Chemical Analyst QC
Abc Farmaceutici S.p.a.
01.2017 - 05.2018
Education
Master's degree - Pharmaceutical Chemistry and Technology
Università degli Studi di Torino
01.2016
High School Diploma -
Liceo Scientifico Piero Martinetti
01.2011
Skills
- Pharmaceutical development
- Project management
- Cross-functional teams interaction
- Teamwork and collaboration
- Organizational skills
- Problem solving
- Computer skills
Languages
Italian
Bilingual or Proficient (C2)
English
Upper intermediate (B2)
German
Beginner (A1)
Personal Information
- Date of Birth: 09/22/1992
- Nationality: Italian
- Driving License: B
Digitalcompetence
Competent with most Microsoft Office programmes
Timeline
Technical R&D Senior Expert Science and Technologies
Advanced Accelerator Applications, a Novartis Comp
09.2023 - Current
Technical R&D Scientist
Advanced Accelerator Applications, a Novartis Company
10.2020 - 08.2023
R&D Pharma Technologies Specialist
CID (Carbostent & Implantable Devices) member of Alvimedica
06.2018 - 09.2020
Chemical Analyst QC
Abc Farmaceutici S.p.a.
01.2017 - 05.2018
High School Diploma -
Liceo Scientifico Piero Martinetti
Master's degree - Pharmaceutical Chemistry and Technology
Università degli Studi di Torino
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