Abdibio Bioanalytical Development Specialist

Abdi İbrahim İlaç Sanayi ve Ticaret A.Ş.

Abdi İbrahim, founded in 1912, has the largest product portfolio in the sector and is the largest employer in the Turkish pharmaceutical industry with 5.500 employees. Abdi İbrahim has been the leader of Turkey’s pharmaceutical industry since 2002 with its powerful vision. Today, Abdi İbrahim exports more than 70 countries. As a corporate citizen working towards creating a better world and a better future, adhering to its mission in the sector and to the requirements of societal priorities, Abdi İbrahim focuses on sustainability in all its business processes. Its vision for 2025 - apart from maintaining its status as a wholly local company - is to become "one of the top 100 pharmaceutical companies in the world.

We are looking for Bioanalytical Development Specialist to join our R&D Team in Biotechnological Products Production Facility (AbdiBio) at Esenyurt campus. 

Qualifications:

•         At least 3 years of hands-on experience within the biopharmaceutical or pharmaceutical industry, in ELISA or cell-based bioassay field.
•        Hands on experience on aseptic mammalian cell culture techniques.
•        Confirmed understanding of scientific principles for wide range of analytical techniques strongly preferred. ELISA and Cell Based Assay experience with large molecules is strongly recommended.
•        Routine use of MS Office programs are essential.
•        Good knowledge on statistic programs PLA and GraphPad.
•        Good knowledge on regulatory guidance.
•        Strong problem-solving and analysis capabilities.
•       Ability to comprehend and converse in English to communicate effectively.

Duties and Responsibilities:

•       Functional and potency characterization (epitope binding, Fc functional analysis, immunological tests eg.) of biotechnologically produced product.
•       Perform in-lab assay execution support for validation, qualification studies, and routine testing by ELISA and cell-based bioassays.
•      Revise/review specifications, SOPs, and other documents regarding QC-Analytical testing and assay execution.
•      Prepare and review research-related documents (e.g., research plan drafts, revisions, workflows, and technical procedures).
•      Performing analytical method development, qualification and validation according to US and EU pharmacopeia,
•      Review analytical research plans and amendments.
•      Draft and review technical and scientific reports and procedures.
•       As required, lead interactions with sponsors, suppliers, quality assurance auditors, regulatory auditors, and research supervisors.
•      Review analysis data generated by the services and ensure the adequacy of records.
•       Use various extraction techniques, manual testing, automated equipment, and analytical instruments to plan and coordinate biotechnological sample verification and analysis activities in multidisciplinary laboratories.