Emily Marques dos Reis, PhD
Quality & Regulatory Affairs Specialist | Medical Devices at Archo Medical- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
Topline Score
Bio
Experience
-
Archo Medical
-
Brazil
-
Medical Equipment Manufacturing
-
1 - 100 Employee
-
Quality & Regulatory Affairs Specialist | Medical Devices
-
Dec 2022 - Present
Endoprótese vascular Endoprótese vascular
-
-
-
MSC MED
-
Brazil
-
Medical Equipment Manufacturing
-
1 - 100 Employee
-
Regulatory Affairs Analyst | Medical Devices
-
Sep 2022 - Nov 2022
-
-
-
Biocelltis Biotecnologia
-
Brazil
-
Biotechnology Research
-
1 - 100 Employee
-
Innovation Manager
-
Jul 2021 - Aug 2022
As Innovation Manager I work on managing the company's Research, Development and Innovation (PDI) pipeline, ensuring the development of new products in line with the organization's Innovation strategy. Main lines of action: alternative methods to the use of animals, 3D cell culture, pre-clinical tests, advanced therapies, tissue engineering products and bioprinting and dermocosmetics; Responsible for tasks associated with: – Planning, managing and monitoring innovation projects, ensuring communication and management of stakeholders ;– Managing R&D team, ensuring their engagement and training;– Development of a hybrid project management adapted to the development of biotechnology solutions, implementing agile management approaches;– Generating ideas, ensuring the capture of resources and customers, new products, technologies, materials, markets and partners;– Mapping and monitoring biotechnological and market trends; identifying new business opportunities/partnerships;– Regularization of projects, products and processes in national and international regulatory bodies (ANVISA, ISO, OECD, RENAMA, CONCEA);– Preparing documentation, schedule, monitoring and execution of projects, products and processes;– Elaboration and continuous implementation of good manufacturing practices RDC 665/2022 and RDC/48 ANVISA.– Managing reports, analyzing data and working with them to monitor and measure project performance, assisting in decision-making;– Preparing the business case of the projects, presentations to the leadership and monitoring and evolution panels;– Definition of the company's strategic challenges with the board and construction of a portfolio of projects and innovation initiatives in the company;– Interface with areas of intellectual property, marketing, quality, event organization and people management (team feedback, career plan, structuring packages and benefits and support and support for climate and culture integrations).
-
-
Scientific Researcher
-
Apr 2020 - Jul 2021
I worked on design and development of research and innovation projects, including the project CellFate RHE - development of reconstituted human epidermis as an alternative method to the use of animals in the evaluation of safety and efficacy of cosmetic products and CellFate iN - development of an in vitro human pulmonary epithelium model - demand COVID-19.– Conducting bibliographic research in national and international technical publications, verifying the existence of a patent;– Responsible for planning, managing and executing internal and external research and development projects;– Responsible for preparing reports and analyzing data for presentation to the board;– Conducting feasibility analysis and optimization of new products, costs, techniques and processes;– Responsible for the elaboration and continuous implementation of good manufacturing practices RDC 16/2013 and RDC/48 ANVISA;–Responsible for raising funds through economic subsidy from funding agencies (FAPESC, CNPQ, CAPES, FINEP, etc);– Interface with research institutions, providing technical support to customers and partners;– Preparation of marketing material, content and management of social media;– Preparation of datasheets and product guide;– Preparation of teaser projects and products;– Interface with areas of intellectual property, and people management.
-
-
Biotechnologist
-
Dec 2017 - Apr 2020
– Responsible for the elaboration and execution of research and development projects;– Implementation of good practices in cell culture following international guidelines;– Responsible for the elaboration of standard operating procedures (SOPs);– Responsible for the implementation and approval of good manufacturing practices RDC 16/2013 and RDC 48/2013 ANVISA;– Conception and design of the cell and tissue culture sector;– Conducting feasibility analysis and optimization of new products, costs, techniques and processes;– Fundraising, suppliers and packaging.
-
-
-
InteLab
-
Research
-
1 - 100 Employee
-
Researcher/ Laboratory Manager
-
Mar 2014 - Dec 2020
Researcher at the Laboratory of Integrated Technologies - InteLab/ UFSC, with emphasis on the area of Tissue Engineering. Responsible for tasks associated with people and laboratory management: - Supervision and monitoring of undergraduate and master students' work; - Publication submissions and Paper review; - Project financial management, budgets, project costs and equipment selection and acquisition, accountability; - Project development and management; - Preparation of research reports; - Fundraising through the elaboration and submission of research projects to the funding institutions; - Cell culture laboratory design, acquisition of equipment and implementation of good cell culture practices; - Equipment and technique training;
-
-
Education
-
UNESP - Universidade Estadual Paulista
Curso de Pós-graduação Lato Sensu (Especialização), Empreendedorismo e Inovação Tecnológica nas Engenharias -
Universidade Federal de Santa Catarina
Doutorado em Engenharia Química, Tissue Engineering -
Universidade Federal de Santa Catarina
Mestrado em Engenharia Química, Engenharia Química - Processos Biotecnógicos -
Universidade Estadual do Rio Grande do Sul - UERGS
Bacharelado em Engenharia de Bioprocessos e Biotecnologia, Biotecnologia