Senior R&D Formulation & Scale-Up Leader

Gensenta İlaç; Marmara Bölgesi; Hybrid; TRY 600,000 - 900,000; Full time

Benefits offered by this job

Rotation Program

Global Experience

Nursery Support

Paternity Leave

Art & Culture Benefits

Volunteer Programs

Job summary

Gensenta is seeking a skilled scientist to lead formulation development for generic products, including solid dosage forms and injectables. The role involves hands-on lab work, pilot-scale manufacturing, and cross-functional collaboration to meet regulatory and quality requirements.

You will manage projects from planning through scale-up, prepare CTD dossiers, and coordinate with the PMO using SmartSheet, while ensuring timely delivery and compliance across EU and international initiatives.

Qualifications

• Bachelor’s degree in Pharmacy, Chemical Engineering, Chemistry, or related field.
• Minimum 6 years of experience in generic product formulation development.
• Experience in developing non-infringing formulations for solid dosage forms and injectables.
• Experience with EU/international/export projects and regulatory requirements.

Responsibilities

• Conduct formulation studies for development/optimization.
• Operate and monitor lab and pilot-scale equipment.
• Prepare project plans and procure materials.
• Coordinate with cross-functional teams to meet timelines and quality standards.
• Track projects with PMO (SmartSheet).
• Perform analytical testing and evaluate results.
• Scale-up from lab to pilot/commercial scale.
• Coordinate process validation activities.
• Prepare regulatory documentation (CTD) and development reports.
• Address deficiency letters and regulatory queries.

Skills

GxP knowledge

Regulatory guidelines

CTD dossiers

English proficiency

Project coordination

Education

Bachelor's degree in Pharmacy or related field

Tools

Galenical equipment

Pilot-scale equipment

SmartSheet

MS Excel

Job description

Gensenta is seeking a skilled scientist to lead formulation development for generic products, including solid dosage forms and injectables. The role involves hands-on lab work, pilot-scale manufacturing, and cross-functional collaboration to meet regulatory and quality requirements.

You will manage projects from planning through scale-up, prepare CTD dossiers, and coordinate with the PMO using SmartSheet, while ensuring timely delivery and compliance across EU and international initiatives.