Formulation & Process Development Scientist
Remedica · Limassol
Περιγραφή θέσης
About the role
Remedica, a pharmaceutical company based in Cyprus with products distributed in more than 140 countries, is looking for a Formulation & Process Development Scientist. The role covers formulation and process development from early development through scale-up, validation and technology transfer, requiring technical expertise, independent decision-making and cross-functional leadership.
Key responsibilities
- Evaluate the technical feasibility and strategic fit of development projects.
- Conduct or oversee literature, patent and regulatory research for RLDs, APIs, excipients and manufacturing processes.
- Design, develop and optimise formulations and processes using QbD principles, including API and excipient characterisation, risk assessments (DEC/FMEA), prototype development and process parameter definition.
- Run feasibility, prototype, scale-up and industrial-scale trials, and execute formulation and process changes for new and existing products while keeping regulatory compliance.
- Work with Analytical Development, Stability Studies, Quality Assurance, Production, Regulatory Affairs and Project Management.
- Support stability protocols, reports and shelf-life assessments, and review technical documentation and transferred-in formulations from external partners.
- Analyse scale-up and manufacturing data, author and review technical documentation, development reports, technology transfer packages, regulatory submissions (CTDs) and responses to regulatory queries.
- Ensure compliance with SOPs, GDP, cGMP and internal quality systems, and adhere to health, safety and environmental requirements.
- Prepare and review CRFs, technical justifications and reports, and evaluate amorphous solid dispersion technologies such as Hot Melt Extrusion and spray drying.
Required profile
- Bachelor's degree in Chemical Engineering, Chemistry or Pharmacy; Master's in Pharmaceutical Sciences preferred.
- 7-10 years of experience in a relevant field.
- Previous experience in oncology product development and in Hot Melt Extrusion (HME) is preferable.
- Excellent communication skills, problem-solving and critical thinking.
- Very good spoken and written English.
Required skills
- Proficiency in Word and Excel.
- D.O.E. software.
- Basic use of tools specific to the profession.
What we offer
- Competitive compensation package including 14 salaries.
- Provident fund.
- A range of additional benefits supporting personal and professional growth.
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Remedica
Limassol