Basic Purpose and Objective:
• Performs complex laboratory analysis of pharmaceutical products and proficiently uses analytical instrumentation, calculates and analyzes data and records data in adherence with SOP's and the industry.
• Routinely acts as the project leader on multiple projects, interacts with clients, reviews and evaluates data, writes reports and protocols. Responsible for the scientific conduct of the project and communication of regulatory issues with senior level team members.
• Independently performs method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems. Understands and conforms to methods and protocols applicable to assigned tasks. Designs and executes experiments with minimal supervision.
• Prepares study protocols, project status reports, final study reports and other project-related technical documents.
• Reviews, interprets and analyzes data for technical, quality and compliance to protocols, methods and SOPs.
• Communicates data and technical issues to the client and responds to client needs and questions.
• Mentors, trains and coordinates laboratory activities of other team members and assists in troubleshooting instrument and analytical problems.
• Assists with quality systems and new equipment.
• Assists in designing method validation or method transfer protocols and establish project timelines.
• BS/BA /MSC with at least 2 years GMP experience within pharmaceutical and/or biotech.
• Must have strong experience with HPLC, GC, DPI, Cascade impactor, KF, Nebuliser
• Solid understanding and knowledge of general chemistry and separation science
• Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
• Ability to utilize Microsoft Excel and Word to perform tasks
For more information and to apply for this role please call Zoe on +353 1 2784671 or e-mail firstname.lastname@example.org
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 2784671