Medical R&D Method Development and Validation Analyst

Medical R&D Method Development and Validation Analyst

Galway

Dillon Engineering is seeking an experienced Medical R&D Method Development and Validation Analyst to join their team in Galway. This is an opportunity to be part of a dynamic team within our Client’s Medical / Veterinary Research and Development function. We are looking for individuals who will support and drive their vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers. This is a key role in the research and development area reporting to the R&D Team head, ensuring high standards of R&D analytical methods and formulations at all times.

This person will have 5 to 10 years’ experience in analytical method development and validation.

KEY RESPONSIBILITIES:

• Develop and validate new R&D analytical methods (active, related substances and/or preservatives, Cleaning method) in line with ICH, EU and other relevant requirements.

• Development and validation of analytical methods required for reverse engineered development products.

• Development and validation of Elemental impurity method, Particle size methods or other analytical methods required during the development of a medical or veterinary Pipeline product.

• Project management and coordination of all analytical activities associated with pipeline product development.

• Perform chemical and physical evaluation of R&D lab trials, optimization batches and process validation batches and stability batches.

• Perform drug substance and brand leader sample characterization.

• Perform standardization of drug substance for preparing the secondary reference standards.

• Preparing the analytical test procedures, Stability Protocols, Method validation protocols and reports, method transfer protocols and reports, SOPs and stability protocols and reports.

• Conduct and manage stability testing of the process validation and optimization batches and method transfer of the R&D finished product.

• Assist data reviewer in the checking of R&D analytical data generated and maintain the instrument calibrations.

• Ensure availability of the required standards/columns and reagents for R&D projects.

• Prepare responses to customer and Authority technical queries for analytical issues in coordination with the relevant formulator.

• Ensure analytical log books/experiment registers are completed regularly and maintained in line with GLP and company requirements.

• Test trial samples from Formulators and provide the results as per the agreed timelines.

• Prepare and review Stability Reports.

• Update stability Testing reports as required.

• Conduct and manage analytical method transfer to QC laboratories or customer laboratories.

• Represent the company at the time customer audits or Authority inspections.

• Maintain R&D laboratory and analytical data and systems as per GMP and GLP requirements.

• Project manage and coordinate analytical activities assigned to you by management.

COMPETENCIES:

• Excellent analytical, reasoning and science skills.

• Strong analytical science background.

• Establishes strong working relationships with others, building team rapport and creating a cohesive team environment.

• Displays a positive outlook with strong coaching skills, maintaining interest at all times.

• Methodical, systematic and structured approach to organising work. Practical, action-orientated approach to managing priorities.

• Makes effective and consistent decisions in a timely manner.

• Positive and proactive person who is energised by having great responsibility.

• Takes personal responsibility for making a decision and taking action within their own area.

• Escalates issues appropriately.

• Takes action to correct poor performance by being fair and consistent in approach.

• Displays flexibility, willingness to succeed and goes the extra mile.

• Strong computer skills in MS Office, Excel and other relevant analytical software.

COMPETENCIES:

• Excellent analytical, reasoning and science skills.

• Strong analytical science background.

• Establishes strong working relationships with others, building team rapport and creating a cohesive team environment.

• Displays a positive outlook with strong coaching skills, maintaining interest at all times.

• Methodical, systematic and structured approach to organising work. Practical, action-orientated approach to managing priorities.

• Makes effective and consistent decisions in a timely manner.

• Positive and proactive person who is energised by having great responsibility.

• Takes personal responsibility for making a decision and taking action within their own area.

• Escalates issues appropriately.

• Takes action to correct poor performance by being fair and consistent in approach.

• Displays flexibility, willingness to succeed and goes the extra mile.

• Strong computer skills in MS Office, Excel and other relevant analytical software.

QUALIFICATIONS:

• Degree in Pharmacy or relevant Science Discipline.

• At least 5 to 10 years’ experience in an R&D Analytical development role.

• Strong analytical, time management and organisational skills.

• Excellent written and verbal communication skills through English.