Product Stability & Data Scientist - Biopharmaceutical
|Job Title:||Product Stability & Data Scientist - Biopharmaceutical|
|Salary:||Excellent salary and benefits|
|Contact Name:||Steve Twinley|
|Job Published:||September 13, 2019 17:51|
A pioneering Europe-based Pharmaceutical organisation specialising in the treatment and prevention of allergies. Their unique focus is on the vaccination and prevention of conditions such as hay fever and their products are fascinating, complex and ever-changing. The company employs around 270 people in Worthing and has an excellent reputation for providing career development opportunities, challenging and engaging work and a pleasant, vibrant working environment.
This is a fascinating and intellectually challenging role based in the Product Stability team which has close links with Drug Formulation & Development, QC, QA, Reg Affairs and other departments. As such, you will interact with people across different groups, providing data to internal and external customers to support product stability and data interpretation functions.
Combining your scientific understanding with your knowledge of GMP (together with GLP and GCP, which will be trained as necessary), you will support the Stability Manager with the planning and management of stability trials, authoring and checking of product stability protocols, file notes and reports, and performing detailed analysis of stability data. There is also a routine element to the role, performing QC release of raw materials (by checking records and approving them) and reading data from data loggers. Some of your time will also be spent in the lab, building on your knowledge of different analytical methods. In turn, you will interpret scientific data and provide your findings to the teams who will incorporate their data in subsequent documentation (Quality documents, regulatory submissions etc).
You will become known as one of the key contacts relating to Stability and as such will need to work with various systems such as LIMS (Laboratory Information Management System), Excel, Access and other bespoke software. You will check the accuracy of data, interpret and present results, ensure that information is communicated clearly across different department and prepare protocols that follow GMP guidelines and other regulations.
As your role evolves, you will become part of an ongoing initiative to consolidate, update and optimise stability protocols across a range of different drug products. This will provide considerable opportunities for taking on longer-term projects and challenges as the company continues to grow.
The successful candidate must have strong communication skills and the ability to work alongside scientists at different levels. You will ideally have a degree in Chemistry, Biochemistry, Microbiology, Maths or some other scientific discipline, combined with some experience in a commercial environment that is based around data analysis or statistical / graphical representation of data.
You must have good Excel skills (VBA macros, V lookups etc) and the ability to analyse and manipulate complex scientific data using different statistical packages. 1-2 years+ hands-on experience performing Pharmaceutical Stability trials would be an advantage, though not essential, and an understanding of Pharmaceutical Stability trials and the applicable guidelines would be of benefit. Full details are available on request, so apply now!
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