R&D PHARMACEUTICAL DEVELOPMENT EXECUTIVE

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, one of Turkey's leading, oldest, and most established pharmaceutical companies, has been serving public health for nearly a century. With its renewed identity in 2020, the company is working towards providing broader geographical coverage, serving more patients, and offering new and comprehensive solutions, all while facilitating patient access to medication. Also export to the region that constitutes 70% of the global pharmaceutical market through Turkey. As of November 2022, we continue our operations as one of the establishments within the Eczacıbaşı Group.

What do we expect from our new team member?

• Conduct formulation laboratory studies for products selected for development and/or optimization.
• Operate and monitor galenical laboratory equipment and, when required, pilot-scale manufacturing equipment.
• Identify project requirements, ensure the procurement of necessary materials and resources, and prepare project plans.
• Ensure that project requirements are fulfilled in collaboration with relevant cross-functional teams, within predefined timelines and in compliance with internal quality systems.
• Track and manage projects in coordination with the PMO through SmartSheet.
• Perform and/or coordinate analytical testing and evaluate the results.
• Carry out scale-up activities from laboratory scale to pilot and/or commercial scale.
• Conduct and coordinate process validation activities.
• Prepare regulatory documentation (e.g., CTD) and pharmaceutical development reports.
• Conduct the necessary studies and prepare supporting information to address deficiency letters and queries received from regulatory authorities.

What kind of teammate are we looking for?

• Bachelor’s degree in Pharmacy, Chemical Engineering, Chemistry, or a related field.
• Minimum 6 years of experience in generic pharmaceutical product formulation development.
• Proven experience in developing non-infringing formulations for solid dosage forms and injectable products.
• Experience in risk-based product assessment and patent evaluation.
• Experience in European Union and international/export projects outside Türkiye, with a strong understanding of applicable regulatory requirements.
• Knowledge and hands-on experience in operating laboratory- and pilot-scale manufacturing equipment.
• Strong knowledge of international pharmaceutical guidelines and regulatory requirements (ICH, EMA, FDA, etc.), with experience in the preparation of CTD dossiers.
• Advanced proficiency in MS Office applications.
• Good command of written and spoken English.
• Strong knowledge of GxP requirements, including GLP, GMP, and Data Integrity principles, with demonstrated compliance.
• Proactive and accountable, with strong communication and teamwork skills; eager to learn, solution-oriented, and able to perform effectively in a fast-paced work environment.

What Do We Offer You?

• At Eczacıbaşı, you can steadily improve your personal, professional, and technical competencies by participating in training programs that support you and your career.
• You will have access to opportunities for rotation among more than 50 companies and global experience in over 120 international markets.
• Vacation time at Eczacıbaşı is calculated according to seniority based on your total work experience. Your bring your seniority with you.
• We will always recognize your success through different reward methods.
• You can take advantage of location-independent or hybrid work opportunities through different work models suitable to the nature of your job, and you can determine your own work schedule with flexible work hours. We offer technology and ergonomic support packages to Eczacıbaşı employees who work remotely full-time.
• As a new parent working at Eczacıbaşı, you are privileged. Eczacıbaşı employees who are mothers are provided with monthly nursery support; Eczacıbaşı employees who are fathers are entitled to a 3-week paternity leave.
• People who savor culture and art are here! Thanks to the Eczacıbaşı Group’s founding sponsorship of Istanbul Modern, Turkey's first modern and contemporary art museum, you can visit the museum for free. Additionally, thanks to Eczacıbaşı Group’s founding sponsorship of Istanbul Foundation for Culture and Arts (İKSV), you can also enjoy the privilege and discounts of İKSV’s Lale Card to all İKSV events.
• You can participate in Eczacıbaşı’s volunteering activities, every one of which prioritizes social benefit, and get involved in projects that create social impact.
• We are committed to ensuring equal opportunity of employment. We value diversity and do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status or seniority.

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