Development Technologist - Formulation D
Development Technologist - Formulation Development: County Waterford. Job Purpose: 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 company's technical/scientific capability. Responsibilities: • 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. 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. • Self-motivation and leadership skills are required. • Strong attention to detail is critical. • Project management skills are advantageous. • Knowledge of Quality by Design and Statistics. • Knowledge and proficiency of Microsoft products including detailed knowledge of Excel, Word and PowerPoint. • Ability to work under pressure, coping with more than one conflicting task at once is essential. This job originally appeared on RecruitIreland.com.
159 days ago