R&D Formulation Senior Specialist

EXELTİS İLAÇ SANAYİİ VE TİCARET A.Ş.

Exeltis Pharmacueticals operates in more than 40 countries through over 40 affiliates. With a team of over 4,000 professionals and a portfolio of more than 300 medicines, it is committed to improving quality of life by delivering accessible, effective, and high-quality healthcare solutions.

As Exeltis Turkey, we provide access to first-class effective treatment solutions and focus on continuous innovation and improving human health to make a strong impact in the healthcare sector. Guided by this mission, we export our products in the therapeutic areas of Women's Health, Respiratory, Pain, Inflammation, and Musculoskeletal to 34 countries across 4 continents.

We are looking for a passionate and strategic R&D Formulation Senior Specialist to join our team at Exeltis Türkiye Çerkezköy Manufacturing and R&D facility.

Qualifications

• Bachelor’s degree in Pharmacy, Chemical Engineering, Chemistry or a related scientific discipline,
• Minimum 5–7 years of experience in pharmaceutical formulation development or a similar R&D position,
• Experience in the development of pharmaceutical products for FDA-regulated markets is required or strongly preferred,
• Familiarity with FDA expectations for pharmaceutical development, including CMC documentation and submission support,
• Strong knowledge of formulation principles, excipients, manufacturing processes, scale-up and stability studies,
• Experience with manufacturing support is an advantage,
• Knowledge of GMP requirements and pharmaceutical development documentation,
• Strong analytical thinking, problem-solving and project management skills,
• Ability to work independently, manage multiple priorities and collaborate effectively with cross-functional teams,
• Must good written and spoken English skills.

• Develop and optimize pharmaceutical formulations for new product development projects.
• Conduct pre-formulation, formulation and compatibility studies.
• Plan, perform and document laboratory trials, scale up batches and submisson batches.
• Work with different dosage forms, such as oral liquid suspensions, semi-solids or other relevant products.
• Evaluate and select suitable active ingredients, excipients, packaging materials and manufacturing processes.
• Support scale-up, validation r activities from R&D to manufacturing sites.
• Prepare and review development reports, batch records, protocols and other technical documentation.
• Review analytical, stability and manufacturing data; identify potential formulation issues and recommend solutions.
• Participate in projects intended for the US market and support development activities in line with FDA expectations.
• Prepare or contribute to CMC-related documentation for regulatory submissions, when required.
• Work closely with Analytical Development, Regulatory Affairs, Quality Assurance, Production and other relevant departments.
• Ensure that all R&D activities are performed according to GMP requirements, internal procedures and applicable guidelines.
• Provide technical guidance and support to junior team members.