Pharmaceutical Development Analyst
Please ensure you read the below overview and requirements for this employment opportunity completely.
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.
• Ensuring the general H&S, cleanliness and tidiness of workplace and laboratory and
assist management team in maintaining the laboratory in an audit readiness state at
all times.
• Training or assisting in training new or existing personnel in laboratory techniques.
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
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.
Salary - £28,829 - £33,441 (depending on experience)
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