Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Affiliations
Timeline
Generic
Zaenab

Zaenab

Research and Development Staff & IVD Expert Staff
Cikarang,JB

Summary

Experienced in leading regulatory projects for domestic product distribution permits, including CPAKB and TKDN documentation. Involved in the development of various in vitro diagnostic (IVD) products such as rapid tests, POCT devices, PCR and extraction kits, and glucometers. Skilled in IVD laboratory design, from room layout planning to equipment specification. Proficient in laboratory techniques, data analysis, scientific writing, and presentations. Highly analytical, adaptable, and eager to grow professionally.

Overview

7
7
years of professional experience
22
22
Certifications
2
2
Languages

Work History

Research and Development Staff & IVD Expert Staff

PT Cahaya Hasil Cemerlang Multi Manufaktur
03.2023 - Current
  • As a member of the R&D team, I served as the project manager for the registration of distribution permits for domestic products. My responsibilities included cross-departmental coordination, preparation of CPAKB (Good Manufacturing Practices for Medical Devices) documentation, and compilation of TKDN (Domestic Component Level) reports. I was also actively involved in the development of in vitro diagnostic (IVD) products, including rapid tests, point-of-care testing (POCT) devices, PCR kits, nucleic acid extraction kits, congenital hypothyroidism screening tools, glucometers, GCU meters, and GCU sAdditionally, I was responsible for the conceptualization and design of the IVD laboratory, covering room layout planning, as well as determining equipment and material specifications.ations.

Laboratory Analyst

Pertamina Jaya Hospital
02.2022 - 04.2022
  • Extraction of genetic material obtained from swab patients; Responsible for the validation of PCR swab results; Processing and performing PCR swab tests according to the applicable SOP; Maintain the cleanliness of laboratory equipment to keep it hygienic and free of contamination; Carry out the implementation of K3 principles when working in the laboratory area

Biomedical Science Master Thesis Student

Eijkman Institute
01.2022 - 01.2022
  • My latest research project was about "specificity and sensitivity analysis of anti-PCV13 polyclonal antibody to Streptococcus pneumoniae and S. agalactiae polysaccharide capsules for the development of immunodiagnostic tests in central nervous system infections"

Laboratory Analyst

Kartika Pulomas Hospital
07.2021 - 11.2021
  • Extraction of genetic material obtained from swab patients; Responsible for the validation of PCR swab results; Processing and performing PCR swab tests according to the applicable SOP; Maintain the cleanliness of laboratory equipment to keep it hygienic and free of contamination; Carry out the implementation of K3 principles when working in the laboratory area

Summer Research Program, Biomedical Research Project

University of Tsukuba
01.2021 - 01.2021
  • The 11th Summer Research Program 2021 by the Faculty of Medicine at the University of Tsukuba that held Online from September 21 to 30, 2021. Participants will have an opportunity to explore the latest biomedical research at Tsukuba, participate in the workshops, and attend the Tsukuba Global Science Week Online Conference. Tsukuba Medicine also plans to have special lectures and social events for the participants to learn about Tsukuba and Japanese culture.

Laboratory Assistant

Basic Science Laboratory, PPBS, Universitas Padjadjaran
08.2018 - 07.2019
  • Supervise the basic chemistry module in Basic Science Laboratory, PPBS, Universitas Padjadjaran

Laboratory Assistant

Biomolecular of Health and Food Laboratory, Universitas Padjadjaran
08.2018 - 07.2019
  • Supervise the biochemistry module in Biomolecular of Health and Food Laboratory, Universitas Padjadjaran

Bachelor Thesis Research Student

Research Centre for Molecular Biotechnology and Bioinformatics, Universitas Padjadjaran
01.2019 - 06.2019
  • My research project was about "In Silico Interaction Analysis of Aptamer from SELEX results with MPT64 Protein"

Education

Magister Ilmu Biomedik - M.Biomed

Universitas Indonesia
01.2022

Sarjana Sains - S.Si

Universitas Padjadjaran
01.2019

Skills

Presentation

Certification

Aedes aegypti ber-Wolbachia: apakah efektif memberantas demam dengue? - Universitas Indonesia - 2023

Accomplishments

  • Highest GPA 2017 - 2019
  • Participant of the Yogyakarta Regional Government National Science Olympiad 2017

Affiliations

  • Himpunan Mahasiswa Magister Ilmu Biomedik 2021 - 2022 Vice Head of Academic
  • Badan Eksekutif Himpunan Mahasiswa Kimia FMIPA UNPAD 2017 Scientific Department Staff
  • Chemistry Fun Days and National Seminar of Chemistry 2017 - 2018

Timeline

Research and Development Staff & IVD Expert Staff

PT Cahaya Hasil Cemerlang Multi Manufaktur
03.2023 - Current

Laboratory Analyst

Pertamina Jaya Hospital
02.2022 - 04.2022

Biomedical Science Master Thesis Student

Eijkman Institute
01.2022 - 01.2022

Laboratory Analyst

Kartika Pulomas Hospital
07.2021 - 11.2021

Summer Research Program, Biomedical Research Project

University of Tsukuba
01.2021 - 01.2021

Bachelor Thesis Research Student

Research Centre for Molecular Biotechnology and Bioinformatics, Universitas Padjadjaran
01.2019 - 06.2019

Laboratory Assistant

Basic Science Laboratory, PPBS, Universitas Padjadjaran
08.2018 - 07.2019

Laboratory Assistant

Biomolecular of Health and Food Laboratory, Universitas Padjadjaran
08.2018 - 07.2019

Sarjana Sains - S.Si

Universitas Padjadjaran

Magister Ilmu Biomedik - M.Biomed

Universitas Indonesia

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Zaenab Research and Development Staff & IVD Expert Staff