Pharmaceutical Development 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
• To adopt a GMP approach at all times and be mindful of data integrity requirements when 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.

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.

Duration: Full time, Permanent

Location: Newry

Additional Information:

• This role will be based in a site that produces and handles penicillin, and as such, this role would not be suitable for those that have a penicillin allergy.
• Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered.
• We regret that applications received after the closing date and time will not be accepted.

Norbrook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy, we would particularly like to welcome applicants from the Protestant Community.