Senior Formulation & Process Development Scientist

Senior Formulation & Process Development Scientist

Remedica

Limassol, Cyprus

We are looking for:

A Senior Formulation Scientist to lead formulation and process development activities from early development through scale-up, validation, and technology transfer. The role requires a high level of technical expertise, independent decision-making, cross-functional leadership, and contribution to strategic R&D objectives, ensuring robust, scalable, and compliant pharmaceutical products.

As a Senior Formulation & Process Development Scientist you will be responsible to:

• Lead the evaluation of product technical feasibility and strategic fit for development projects, providing expert recommendations to R&D management;
• Independently conduct and/or oversee literature, patent, and regulatory research for RLDs, APIs, excipients, and manufacturing processes to support product development strategy;
• Design, develop, and optimize formulations and manufacturing processes using Quality by Design (QbD) principles, including:
  • Lead feasibility, prototype, scale-up, and industrial-scale trials, ensuring processes are robust, reproducible, and commercially viable.
• Act as the technical lead for scale-up and technology transfer activities, including preparation and approval of master batch records, process instructions, and production support during trial and validation batches;
• Plan, execute, and review process validation activities;
• Lead formulation and process changes (including API changes) for both new and existing R&D-developed products, ensuring regulatory compliance and minimal impact on product performance;
• Collaborate closely with Analytical Development, Stability Studies, Quality Assurance, Production, Regulatory Affairs, and Project Management to ensure aligned and timely project execution;
• Provide scientific input for the preparation, review, and approval of stability protocols, reports, and shelf-life assessments;
• Review and evaluate technical documentation and transferred-in formulations from external partners, ensuring robustness and successful integration into internal processes;
• Perform in-depth analysis of scale-up and manufacturing data to identify trends, risks, and opportunities for continuous improvement;
• Author, review, and approve high-quality technical documentation for development reports, technology transfer packages, regulatory submissions (CTDs), and responses to regulatory queries;
• Ensure full compliance with SOPs, GDP, cGMP, and internal quality systems throughout all development activities;
• Mentor, train, and technically support junior and mid-level scientists, fostering scientific development and best practices within the team;
• Actively contribute to departmental planning, timelines, and resource allocation, supporting project prioritization and risk mitigation;
• Participate in audits, inspections, and regulatory interactions, providing technical expertise and responses as required;
• Drive continuous improvement initiatives related to formulation design, process efficiency, cost optimization, and innovation;
• Ensure strict adherence to health, safety, and environmental requirements, promoting a strong safety culture within the laboratory and production areas;
• Prepare and review CRFs, technical justifications, and internal/external reports as required;
• Evaluate latest technologies like Spray drying, Hot Melt Extrusion, amorphous solid dispersion etc. as per product requirement and present the opportunities to introduce new technologies in Remedica;
• Perform any other duties assigned by the Head of Formulation and Process Development.

What you will bring:

• Bachelor’s in chemical engineering, Chemistry and Pharmacy;
• Master’s degree in pharmaceutical sciences preferred;
• 8-12 years of experience in a relevant field;
• Previous experience with formulation and process oral dosage forms is mandatory;
• Oncology product development and experience in HME & Spray drying techniques is preferable;
• Experience with leading a team is preferable;
• Very good spoken and written English required;
• Proficiency in Windows, Word, Excel.