22053-Analytical Scientist-Meath Contractor

This is an 11-month contract.

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 substance for release, stability and characterization of biologic products under GMP/GDP and analytical method validations/transfers. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.

Responsibilities 

• Execution of analytical method validations and transfers (among different  sites, and between the company and CROs) and write 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.
• Train new analysts

Requirements 

• M.S in analytical chemistry/biochemistry or related field or B. S with a minimum of 3 years of experience in the Pharmaceutical Industry.?
• Experience with analytical testing with Ultrahigh Pressure Liquid Chromatography (UPLC)/High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis, or other large molecule characterization technique
• Strong oral and written communication skills
• Ability to work in a team environment with cross-functional interactions is essential
• GMP working experience
• Perform supporting activities for general lab operations, training, new product introduction, method verifications and method transfers.
• Execution and review of analytical method validations and transfers (among different sites, and between the company and CROs)
• Execution and review of analytical testing of drug substance release, stability, method qualification, incoming goods, ID testing, and characterisation for biologics under GMP/GDP.
• Cross-train Scientists within the department for new and existing technologies.
• Ability to organise and establish testing schedules and adhere to deadlines.
• Support equipment maintenance, calibration and qualification work
• Perform periodic review of instrument systems
• Generate instrument data in support of SDLC Validation.
• Initiate, review, and support deviations, CAPAs, and, risk assessments, and change records as required.
• Preparation of analytical methods, SOPs and other documents as required
• Understanding of current manufacturing processes
• Author technical protocols and reports as required
• Analyse and optimise current lab/business processes in the laboratories and support implementation activities of the technologies and methodologies.