R&D Analytical Analyst

Job Overview
The successful candidate will work as part of a cross functional R&D team and gain a broad understanding of the processes involved in bringing new pharmaceutical products to market. 
The analyst will perform chemical and physical testing of R&D batches in relation to method development, validation and transfer of finished product methods as well as process validation and stability study testing. The successful candidate will be responsible for the execution of their daily tasks to meet overall project timelines and report results to a senior analyst in a timely and accurate manner.

Main Activities/Tasks

• Ensure you have the skill set necessary to operate within the required competency level as per key skills matrix.
• The development, optimisation, validation and transfer of finished product methods of analysis using a range physio-chemical techniques in accordance with relevant standard operating procedures and regulatory guidelines and requirements.
• Perform stability testing of R&D batches of finished product all in line with current GMP and V/ICH requirements.
• To assist in the collection of samples from the production suites in support of development/pre-approval and process validation batches and perform analytical testing on same batches.
• To assist in trending of analytical data and in performing investigative analysis for out of specification results in accordance with company procedures.
• Ensure all work is executed in accordance with Methods of Analysis, SOPs, protocols, and GMP guidelines where required. 
• To adopt a GMP approach at all times and be mindful of data integrity requirements when executing analysis and the corresponding recording of data.
• The generation, interpretation and recording of data, results, draft methods, protocols and reports pertaining to Method development, validation and transfer alongside stability studies and process validation of finished product.
• Ability to actively problem solve, troubleshoot and provide solutions to analytical challenges during testing of finished product methods.
• Conducting departmental training in all validated finished product methods as part of the method transfer process.
• Calibration of relevant Laboratory equipment daily.

Essential Criteria:
Applicants must therefore demonstrate the following essential criteria on their application form in order to be considered:

• Educated to degree level in a science related discipline. 
• Previous experience working in/exposure to a cGMP environment. 
• HPLC, UPLC, GC and practical wet chemistry experience. 
• Knowledge of VICH guidance for Method Validation of Finished product methods and Process validation and Stability studies. 

Desirable Criteria:
Due to the nature of the role preference will be given to applicants demonstrating the following desirable criteria:

• 1 years previous experience working in a GMP environment 
• Demonstrable experience of working with Empower lab management system
• Previous analytical Method Development and Validation experience. 
• Finished product stability study experience.
• Experience with troubleshooting relevant lab equipment; HPLC, UPLC, GC etc. 

Duration: Full time, Permanent 
Location: Newry

Benefits:

• Free Life Assurance 
• Company Pension Scheme 
• Healthcare cash plan 
• 32 days annual leave 
• Wedding Leave
• Company Sick Pay 
• Employee well-being initiatives
• Employee Assistance Programme 
• On-site free parking 
• Canteen Facilities 
• Employee Perks scheme 
• Employee Recognition scheme 
• Career development opportunities