Our R&D Formulations Team have a new opportunity for a Development Technologist to join their growing team. Reporting directly to the R&D Formulations Development Manager, this role will be responsible for the Formulation Development of Generic and New Drug Products through:
- Applying a thorough knowledge of all processes involved in the manufacture of pharmaceutical products.
- Applying a thorough knowledge of pharmaceutics to the development of drug products and the interpretation of in-vitro data to predict in-vivo performance.
- Performing formulation, process development and optimization trials using experimental design techniques
- To carry out pre-formulation and formulation development trials on high potency molecules.
- Manufacture, pack and label clinical batches for human consumption.
- Communication of project data at internal meetings and through formulation reports and presentations.
- Lead pivotal scale cGMP exhibit batch based upon a sound knowledge of site and departmental SOPs, and an understanding of ICH/FDA/EMEA requirements as they relate to formulation and process development activities.
- Generate GMP documentation, e.g. SOPs, Batch Manufacturing Records and protocols.
- Maintain a comprehensive knowledge of formulations and process development disciplines through research and scientific literature.
- Identify, assess, recommend and implement internal and external opportunities to broaden EirGen Pharma’s technical/scientific capability.
Responsibilities of this role include:
- To ensure that all work carried out is in compliance with the required regulatory and health and safety standards.
- To comply with company policies and procedures.
- To process batches of products/ components/ raw materials in an efficient and timely manner to meet with project timelines.
- To complete all documentation in real time where applicable and within the agreed turnaround times and to ensure right first time.
- To work within a team environment to ensure all project timelines are met.
- Ascertain at the end of a development cycle a stable, effective product suitable for clinical batch manufacture and regulatory submission.
The ideal candidate for this role would meet the following criteria:
- Third level qualification in Pharmaceutical Science or equivalent related discipline.
- Minimum 3 years experience within the pharmaceutical industry, preferably in an operational setting.
- Practical experience in formulation development.