Development Technologist- Waterford. Job Purpose: The ideal candidate would 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 optimisation 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 the company's technical/scientific capability. Minimum Qualifications & Experience sought: • 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. • In-depth knowledge of production operations such as dispensing, blending, granulation, compression, encapsulation, coating and packing. • Good troubleshooting skills are essential. • Excellent written, oral and interpersonal skills are essential. This job originally appeared on RecruitIreland.com.
385 days ago