16925 – Scientist-Meath Contractor

This is an 11-month contract initially.

Purpose

The Biologics Analytical Research & Development department is seeking applicants for a Scientist position which is a laboratory-based scientific role tasked with analytical testing of drug substances for release, stability, and characterization of biologic products under GMP/GDP, performing analytical method qualification via analytical method transfers, analytical method validation. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. The Analytical Scientist will run the daily activities in the Analytical laboratories.

Responsibilities

• Participate in the start-up of operations within the new laboratory facility which will include support of equipment qualification, documentation generation such as SOPs, Work instructions authoring and review as well as contributing to lab and process workflow establishment.
• Perform supporting activities for general lab operations, training, new product introduction, method verifications and method transfers.
• Ability to organize and establish testing schedules and adhere to deadlines.
• Execution of analytical method validations and transfers (among different sites, and between the company and CROs) and writing technical protocols and report
• Execution of analytical testing of drug substance release, stability, and characterization for biologics under GMP/GDP
• Support equipment maintenance, calibration, and qualification work
• Preparation of analytical methods, SOPs, and other documents as required
• Other analytical activities in consultation with the Supervisor
• Works in accordance with applicable internal company regulations: safety, health, and environmental protection.

Requirements

• Degree in Chemical Engineering, Pharmacy, Pharmaceutical Sciences or equivalent
• Experience with analytical testing with Ultrahigh Pressure Liquid Chromatography (UPLC)/High-Performance Liquid Chromatography (HPLC), Capillary Electrophoresis, or other large molecule characterization technique
• Experience with biochemical analytical techniques and antibody biochemistry, binding assays as ELISAs and functional cell-based assays
• Analytical Instrumentation Qualification
• Strong oral and written communication skills
• The ability to work in a team environment with cross-functional interactions is essential
• GMP working experience
• Experience in analytical method qualification and transfers