Basic qualifications:
• Bachelors or Masters degree in Chemistry or related disciplines with an extensive track record of relevant industry experience or Ph.D. in Chemistry or related disciplines with at significant relevant industry experience.
• Extensive experience of working in a GMP environment.
• Proven technical leadership, communication and influencing skills.
• Significant laboratory experience in analysis, both analytical and data handling to make a significant contribution to the progression of a project (e.g. method validation, method transfer, stability all phases).
• Experience of use of IT tools to visualize and trend stability data and/or other analytical data related to pharmaceutical products.
• Compilation and delivery of stability data and knowledge for regulatory submissions.
• Collation and presentation of scientific data and knowledge to a wider range of stakeholders.
• Good understanding of pharmaceutical product stability design, delivery and external guidance.
Preferred qualifications:
• Proven track record of demonstrating good scientific judgment and initiative, working to deadlines.
• Experience of working with matrix teams to improve quality, processes and implement best practice.
• Experience of using scientific expertise to solve project related problems for colleagues and other business areas.
• Knowledge and experience of planning and prioritisation of work for team and more junior staff.
• Experience of conducting Questionable/Out of Specification and any potential deviation investigations in accordance with the procedures and timelines
• Ensuring all necessary testing is performed within the defined time frame and is reviewed against the appropriate specifications required for clinical, stability or commercial testing.
• Authorship of stability protocols and technical memoranda, evaluating the stability data.
• Generating and collating data for regulatory submissions and providing appropriate discussion and conclusions.
• Experience of preparation and presenting at internal and external audits in all aspects of analytical work, including project data, method transfer and ASD data as well as wider GSK strategy.
• Experience of interrogating data and trends and providing conclusions for stakeholders.
• High level problem solving capability.
• Experience of training others in area of technical expertise.
Details:
GSK is a science-led global healthcare company with R&D playing a fundamental role in helping GSK to achieve its mission – enabling people to do more, feel better and live longer. The Analytical Sciences and Development (ASD) department, part of Product Development & Supply, undertakes critical expert work in supporting the drug development process as well as existing products, to deliver new medicines to patients by accelerating access to novel medicines, preventions and cures.
We now have a vacancy for an Investigator with analytical chemistry experience, related to the development of pharmaceutical products and knowledge of product stability and regulatory data compilation, to join GSK’s Global Stability and Release department within ASD. In this exciting role, you will have responsibility and accountability for the delivery of high quality data sets and the associated pharmaceutical product stability data and knowledge. You will be expected to present and lead key knowledge and understanding within regulatory submissions for a portfolio of projects. You will use your expertise in product stability knowledge and use of data visualisation tools, to effectively and efficiently support the delivery of new drug products.
If requiring an adjustment for a disability, once selected for
Interview you may contact ukdiversity.recruitment@gsk.com
Closing date for applications: 4th November 2016
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
Thank you for your interest in this opportunity.
*LI-GSK
Contact information:
You may apply for this position online by selecting the Apply now button.
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