Formulation & Process Development Scientist

Remedica

Limassol, Cyprus

We are looking for:

A Formulation & Process Development Scientist to conduct research and formulation trials for product development and re-development of new and existing generic drug products

As a Formulation & Process Development Scientist you will:

Perform evaluation of the product technical suitability at Remedica;
Conduct literature research on the originator drug product (RLD)/drug substance prior to the initiation of lab activities including Product & API patent (if applicable);
Focus on technical aspects: Designing of the formula & process as per QbD, evaluate equipment feasibility, API physical characterisation, DEC study, feasibility/prototype trials/scale up trials including the optimization of process and process parameters, stability testing in accordance to the specifications as per the guidance of Supervisor/Head;
Cooperate with Analytical Method Development and Validation for the assessment of prototype formulation performance. Based on this evaluation, planning of further formulation activities to ensure satisfactory development outcome;
Cooperate with Technology Transfer and Scale up for the smooth transition of the prototype formulation to the production area;
Cooperate with Project Management for verification of project status and establishment of department schedule;
Do planning, organising, follow-ups must be made to achieve target timelines among technical teams as per the guidance from the Supervisor/Head;
Review of technical documents from external parties, undertaking communications with them, verifying the robustness of received formulations when transferred-in at small scale in the R&D unit. Preparation of summary reports to the Supervisor/Head;
Proceed with Compiling/reviewing formal documentation required for product registration purposes;
Provide scientific written responses, backed up with references to the applicable guidelines/literature, to deficiency letters from authorities;
Maintain accurate records of the Formulation development activities;
Be responsible for the proper application of personal protective equipment and safety procedures;
Conduct preparation of the technical, non-technical reports (wherever applicable), product related documentation as per the SOPs & GDP;
Prepare CRF’s when required;
Ensure that all performed tasks comply to the established regulations and guidelines such as Standard Operating Procedures (SOPs), Good Documentation Practices (cGDP) and the current Good Manufacturing Practices (cGMP);
Carry out any other duties as assigned by the immediate supervisor.