Bioequivalance Specialist

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"Bilim Pharmaceuticals, started its operations in 1953, is a completely-local-investment company that produces and markets pharmaceuticals. Bilim Pharmaceuticals conducts its production activities in two separate facilities located in Gebze and Çerkezköy and exports to over 70 countries. Bilim Pharmaceuticals has always been in the top-three pharmaceuticals companies in its active segments. Bilim attains a continuous growth while accomplishing its strategic targets in the Turkish pharma sector in which there are around 500 pharmaceutical companies."

Bilim İlaç is looking for a "Bioequivalence Specialist" for CMC Management team. A brief job description of the position and preferred qualifications for the suitable candidates are defined below.

1. Degree in preferably Pharmacy, Chemistry, Chemical Engineering, Biology, Molecular Biology and Genetics, Bioengineering or Biomedical Engineering.
2. Preferably, at least 2 years of experience in Bioequivalence, Bioavailability studies, Biowaiver, Clinical Trials in Pharmaceutical Industry.
3. Knowledge about national and international current regulations and guidelines related to Bioequivalence, Bioavailability studies, Biowaiver, Clinical Trials.
4. Fluent in English (able to communicate effectively in written and spoken English).
5. Analytical thinking and problem solving focused.
6. Effective communication, team worker and coordination skills.
7. Good knowledge of Microsoft Office.
8. No military obligation for male candidates.

1. To take part in the conduct of Bioequivalence/Bioavailability studies within the scope of Human Pharmaceuticals, new product studies are carried out in accordance with current national and international regulations.
2. To research reference products.
3. To conduct literature research within the scope of the study design of the products to be studied in Bioequivalence/Bioavailability studies.
4. To contact with Contract Research Organisation (CRO) within the scope of the study to be carried out.
5. To prepare the investigational medicinal products to be used in Bioequivalence/Bioavailability studies in accordance with the regulation and to ensure that they are delivered to the CRO.
6. To follow processes related to the initiation, conduct and reporting of Bioequivalence/Bioavailability studies in CRO.
7. To prepare the relevant Modules (Module 5 and other relevant sections) in CTD format within the scope of the Bioequivalence/Bioavailability study.
8. To carry out literature researches on biowaiver writings and to prepare the report.
9. To prepare the answers to Clinical, Bioequivalence/Bioavailability, Biowaiver questions from the Ministry of Health and Authorities in line with EMA/FDA/ICH/TITCK requirements, to coordinate with other departments to provide the necessary documents.
10. To evaluate change controls within the scope of Bioequivalence/Bioavailability studies and to take necessary actions.
11. To archive all relevant correspondence and documents.
12. To follow national and international regulations, legislations and guidelines regarding the Bioequivalence/Bioavailability studies and Biowaiver processes of Medicinal Products for Human Use; to ensure coordination to ensure that the work carried out meets the current requirements.

In connection with your job application to Bilim İlaç Tic. A.Ş. ("Bilim Pharmaceuticals"), any personal data you provide will be processed by Bilim Pharmaceuticals, as the data controller, in compliance with the Personal Data Protection Law No. 6698. This processing is done to collect, evaluate, and manage recruitment activities. For more information on how Bilim Pharmaceuticals processes your data, please visit: https://www.bilimilac.com.tr/en/protection-of-personal-data

Associate

Full-time

Research, Project Management, and Science

Pharmaceutical Manufacturing