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Formulation & Process Development Scientist

Remedica · Limassol

New
Senior 🇬🇧 English
Word Excel Quality by Design (QbD) cGMP GDP

Job description

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.

Questions fréquentes

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Published 4 hours ago

Expires 1 month from now

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Remedica

Limassol