AbdiBio Manufacturing Science and Technology Specialist

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. Since 2002, Abdi İbrahim has led Turkey’s pharmaceutical industry with a strong vision and today exports to over 70 countries. Committed to being a responsible corporate citizen, the company prioritizes sustainability across all business processes, aligning its mission with societal needs. Its 2025 vision is to remain a wholly local company while becoming one of the top 100 pharmaceutical companies globally.

We are seeking a motivated MSAT Specialist to join our monoclonal antibody production team. In this role, you will be a part of the downstream processing operations, ensuring the highest standards of quality, efficiency, and innovation in the purification of monoclonal antibodies. You will work in a talented team, collaborate cross-functionally, and contribute to the success of our bioprocessing pipeline.

We are looking for an MSAT Specialist to join our Drug Substance Production team at the Biotechnological Production Facility (AbdiBio) on the Esenyurt campus.

The requirements for the successful candidate are:

• Bachelor’s / master's degree in biological science discipline.
• Excellent command of English.
• 6–8 years of core work experience in biosimilar manufacturing or the biotech industry.
• Provide technical support for USP/DSP operations, such as fermentation, cell culture, purification, and Chromatography.
• Provide technical support for cell culture (USP) and protein purification (DSP) operations in a GMP setting.
• Support process monitoring, data trending, and deviation investigations during routine manufacturing.
• Participate in tech transfer, scale-up, and process optimization activities.
• Familiarity with ÄKTA chromatography systems and Unicorn software.
• Understanding of protein purification principles, resin packing/unpacking, and column integrity checks.
• Knowledge of Quality Management Systems such as Change Control, Deviation, Risk assessment, ICH guidelines and CAPA.
• Strong communication and interpersonal skills.
• Knowledge of cGMP.
• Adherence to cGMP compliance in all operations.

The key duties of the successful candidate are:

• Understanding and execution of well-defined procedures within a GMP manufacturing facility.
• Strong understanding of biologics processes (USP/DSP), GMP, and regulatory guidelines Operation and troubleshooting of equipment such as chromatography skids, TFF systems, peristaltic pumps, and pressure vessels.
• Preparation and handling of process solutions under aseptic and cleanroom conditions.
• Adherence to Standard Operating Procedures, logbooks, and Batch Manufacturing Records (BMR).
• Review the CMC document sections.
• Preparation of validation protocols, buffer, Media and product hold protocols.
• Proficient in data analytics, statistical tools (e.g., Minitab), and scientific writing.
• Work closely with cross-functional teams including Production, QA, QC, and Engineering.