Description
Role:- Working as a member of R&D with colleagues in Dublin and the UK and with commercial manufacturing, to ensure the successful, on time file submission of a generic dry powder inhalation product to the US and EU.
- Providing statistical input to development activities.
- Providing historical data-mining and chemometric/ multivariate analysis to identify significant correlations and increase product/ process knowledge/ control.
- Leading the development of multivariate models, e.g. PCA and PLS, designed experiments and statistical process control trending.
- Manipulating diverse process, analytical and manufacturing attribute data sets for efficient analysis.
- Preparing data analysis and statistical input to the CMC regulatory submission for initial filing and for post approval changes and variations in the US and Europe.
- Reviewing product development protocols to assure appropriate statistical rigor.
- Advising, mentoring and training R&D colleagues on appropriate statistical approaches.
Qualifications and essential functions for this position:
- Scientific, Engineering, Mathematics or Statistics qualification (minimum of degree), with relevant experience in statistical/ chemometric data analysis.
- The ideal candidate will have a proven track record of success in the pharmaceutical, chemical or manufacturing industry. They will possess a positive attitude and will want to progress in a fast paced environment.
- High proficiency in Microsoft Excel, relevant statistical and database software.
- Ability to translate statistical data into information and knowledge for R&D colleagues. The candidate must be a good communicator who can present potentially complex information in a clear manner to groups with a broad cross-section of statistical understanding, focusing on helping teams make correct decisions.
- An ability to work flexibly in a changing environment. An ability to multi-task, good attention to detail and priority management essential. Ability to work well under deadlines and pressure.
- Strong technical ability including methodical approach to problem solving and strong technical writing skills.