R&D Pharmaceutical Development Specialist

Gensenta İlaç Sanayi ve Ticaret Anonim Şirketi

Job Description:

The ideal candidate should support our growing work progresses in our R&D Center & to be take an active role on R&D activities and adding value in our organization. She/He is able - ;

• Determine the project necessities and prepare project plans,
• Provide the project requirements with related cross-functional teams in pre-determined time in accordance with in-house quality systems,
• Conduct pharmaceutical development activities and strong follow up the projects,
• Perform and/or ensured to be performed formulation laboratory studies of products that are decided to be developed / optimized,
• Perform and/or ensured to be performed analytical tests,
• Perform scaling activities from laboratory to commercial size,
• Perform process validation studies,
• Prepare the documents for regulatory purpose,
• Support commercial products (optimizations, deviations, technical reports etc.)
• Take role in technology transfer process / projects.

General Qualifications:

• Graduated from Faculty of Pharmacy, University (Graduated), Master degree (ongoing or graduated), PhD degree (ongoing or graduated), or Chemical Engineering with MSc / PhD at Pharmaceutical Technology, Pharmaceutical Engineering etc.
• Having at least 2 years experienced on generic product development.
• Knowledge of and experience in the use of Lab Scale and pilot production equipments.
• Experience in risk-based product evaluation.
• Good knowledge regulatory guidelines (ICH, EMA, FDA etc.) and preparation of CTD dossiers.
• Good knowledge and experience of MS Office applications.
• Good knowledge of written and spoken English.
• Knowledge of GxP; GLP, GMP and Data Integrity.
• Being initiative, having good communication skills, team worker, open to learning, solutionoriented and able to adapt to busy schedules.
• Completed military service for male candidates.