R&D Pharmaceutical Development Executive

About the role

Gensenta, a historic Turkish pharmaceutical leader, is seeking an experienced R&D Pharmaceutical Development Executive to drive formulation projects from laboratory research through pilot and commercial scale. The role will support both domestic and export initiatives, ensuring compliance with international regulatory standards.

Key responsibilities

• Design and execute formulation laboratory studies for new or optimized products.
• Operate galenical and pilot‑scale manufacturing equipment, monitoring performance and quality.
• Define project requirements, procure materials, and develop detailed project plans.
• Coordinate cross‑functional teams to meet timelines and adhere to internal quality systems.
• Track project progress using SmartSheet in collaboration with the PMO.
• Perform or oversee analytical testing and interpret results.
• Scale up processes from lab to pilot or commercial scale and conduct process validation.
• Prepare regulatory dossiers (CTD) and development reports, and respond to authority queries.

Required profile

• Bachelor’s degree in Pharmacy, Chemical Engineering, Chemistry or a related discipline.
• Minimum 6 years of experience in generic pharmaceutical formulation development, especially solid dosage forms and injectables.
• Proven ability to develop non‑infringing formulations and assess patent risks.
• Experience with EU and international export projects and a solid grasp of ICH, EMA, FDA regulations.
• Fluent written and spoken English.

Required skills

• Proficiency with MS Office applications.
• Experience using SmartSheet for project management.
• Hands‑on expertise in analytical testing and process validation.
• Knowledge of regulatory documentation preparation (CTD).
• Understanding of GxP requirements, including GLP, GMP, and data integrity.

What we offer

• Continuous professional development through targeted training programs.
• Opportunities to work on high‑impact projects within a leading pharmaceutical group.