Cache of job #13741714

Job Title

Development Technologist (R&D)

Employer

ICDS Recruitment

Location

Waterford

Description

Job Title: Development Technologist (R&D. Job Purpose: Apply a thorough knowledge of pharmaceutics to the development of drug products and the interpretation of in-vitro data to predict in-vivo performance. Perform process development and optimization trials using experimental design techniques. To carry out pre-formulation and formulation development trials on high potency molecules. Manufacture and pack clinical batches for human consumption. Communication of project data at internal meetings and through formulation reports. 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. 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 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 products/ components/ raw materials in an efficient and timely manner to meet with project timelines. To complete all documentation 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. 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. Other Information. Skills. 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. Project management skills are advantageous. Knowledge of Quality by Design and Statistics. Essential behaviors. Teamwork & collaboration, personal responsibility, problem solving, safety awareness, customer focus, quality orientation, analysis, innovation, initiating action, adaptability. This job originally appeared on RecruitIreland.com.

Date Added

2502 days ago

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