Remedica is a globally active EU-based pharmaceutical company, headquartered in Cyprus and present in more than 110 countries. Founded in 1980, the company has evolved into a trusted generics CDMO and dossier development partner for pharmaceutical companies worldwide. Remedica combines development expertise, EU-based manufacturing capabilities, regulatory know-how and a strong quality culture to deliver competitive, high-quality medicines. Its portfolio includes over 300 products across key therapeutic areas, including cardiovascular, oncology, anti-diabetic, anti-infective, central nervous system, alimentary tract, genito-urinary and musculoskeletal treatments.
Over the last few years, Remedica went through a massive transformational program from a locally recognised reputable company to a global player, respected by its distributors, partners, and clients. The investments into the factories, R&D equipment, new facilities, implementation of best-in-class software, and people development are the baselines for Remedica's success in the future.
The purpose of this role is 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.
Duties & Responsibilities
- 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:
- API and excipient characterization
- Risk assessments (e.g., DEC/FMEA)
- Prototype development
- Process parameter definition and optimization
- 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, including:
- Validation protocol development
- Manufacturing oversight
- Evaluation of validation results
- Support for regulatory submission
- 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.
- Perform any other duties assigned by the Head of Formulation and Process Development in line with
- 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.
Qualifications and skills
- Education: Bachelor’s degree in Chemical Engineering, Chemistry or Pharmacy; Master’s degree in pharmaceutical sciences preferred.
- Experience:
- 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
- Communication Skills:
- Excellent communication skills with the ability to convey technical information clearly.
Ability to communicate with internal departments and external stakeholders via meetings, emails, and teleconferences.
- Excellent communication skills with the ability to convey technical information clearly.
- Physical Skills:
- Ability to work across office, laboratory, and production environments.
- Ability to use appropriate PPE including masks, gloves, and goggles when handling active substances.
- Cognitive Skills: Strong analytical thinking and attention to detail; Ability to solve problems, evaluate data, optimize processes, and work under pressure with minimum supervision; Ability to manage multiple tasks and make timely decisions.
- Language knowledge: Good knowledge of Greek & English
- Digital Skills: Good knowledge of Microsoft office tools
Why Join Remedica?
At Remedica, we offer a competitive compensation package, including 14 salaries, a provident fund, and a range of additional benefits to support your personal and professional growth. Join our team and be part of a company that values innovation, teamwork, and continuous improvement.
Equal Opportunity Statement
At Remedica, we are committed to ensuring equal pay for equal work and work of equal value. To support this commitment, roles are evaluated using a structured, gender‑neutral job evaluation framework, which objectively assesses the knowledge, skills, responsibilities, effort, and working conditions associated with each role. This approach helps ensure fair, transparent, and consistent outcomes across the organization.
We welcome applications from all qualified candidates, regardless of sex, race, ethnicity, disability, religion or belief, sexual orientation, gender identity, or age.