Assay Development Scientist - CMC

<h2>Job Overview:</h2><p style="margin: 0px; text-align: justify;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong><span style="color: windowtext;">Do you want to be a part of the world's leading drug development company?</span></strong></span></p><p style="margin: 0px; text-align: justify;"> </p><p style="margin: 0px; text-align: justify;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong><span style="color: windowtext;">Do you enjoy method development and want to work on a large range of different studies?</span></strong></span></p><p style="margin: 0px; text-align: justify;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong><span style="color: windowtext;"> </span></strong></span></p><p style="margin: 0px; text-align: justify;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong><span style="color: windowtext;">Are you looking for a role with continued training and career progression? </span></strong></span></p><p style="margin: 0px; text-align: justify;"> </p><p style="margin: 0px; text-align: justify;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">The Biopharmaceutical CMC (Chemistry Manufacturing Controls) Solutions team is focused on providing analytical support in the drug development pathway for the characterisation and stability assessment of large protein molecules including: vaccines, antibodies, cytokines and growth factors. The accurate characterisation of a drug is necessary to release manufactured batches of the drug, assess stability (shelf life) and evaluate the impact of changes in manufacturing process or in formulation. This is achieved using a variety of analytical techniques such as: HPLC/ UHPLC, LC-MS,Capillary Electrophoresis, UV spectroscopy, ELISA and mass spectrometry.</span></p><p style="margin: 0px; text-align: justify;"> </p><p style="margin: 0px; text-align: justify;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Working within a dedicated BioCMC assay development team at our site in Harrogate, North Yorkshire, the successful candidate will be involved in the development of analytical workflows and will be primarily responsible for characterisation studies, assay establishment/ team training and assay validation prior to cGMP batch release and stability studies. The <strong><span style="background-color: #ffffff;">Subject Matter Expert </span></strong>will liaise closely with QC Scientists and those who have overall responsibility for the scientific, technical and regulatory conduct of these studies.</span></p><p style="margin: 0px; text-align: justify;"> </p><p style="margin: 0px; text-align: justify;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>The role will be primarily 50% laboratory based and responsibilities will include:</strong></span></p><p style="margin: 0px; text-align: justify;"> </p><ul><li style="text-align: justify;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">The development, establishment and validation of analytical workflows and methods; interpreting and documenting data, method related software customisation, and reporting of results</span></li><li style="text-align: justify;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Provision of scientific expertise; able to give technical advice to internal external clients and guide decision making or trouble-shooting processes</span></li><li style="text-align: justify;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Documentation of studies to the required scientific and regulatory standards, and in accordance with study protocol and Covance standard operating procedure</span></li><li style="text-align: justify;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Understanding of client requirements (i.e. critical aspects) and planning accordingly to deliver targets on time and within budget and to manage study changes</span></li><li style="text-align: justify;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Anticipation of problems that may affect timing or data quality, taking appropriate action to minimise impact or resolve issues</span></li><li style="text-align: justify;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Networking between departments to meet the demands of multi-disciplinary client programs</span></li><li style="text-align: justify;"><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Where appropriate, publish and present at conferences and symposia, etc</span></li></ul><h2>Education/Qualifications:</h2><ul><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">The successful candidate is expected to have a relevant scientific degree and an appropriate amount of laboratory experience</span></li></ul><p style="margin: 0in 0in 0pt;"> </p><h2>Experience:</h2><p style="margin: 0in 0in 0pt;"> </p><ul><li style="text-align: justify;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">The candidate will have experience working with biopharmaceutical products in a CMC environment</span></li><li style="text-align: justify;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;"><span style="color: black;">Experience working with biopharmaceutical products and in structural characterisation studies</span></span></li><li style="text-align: justify;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Expertise in multiple analytical techniques is required, including Capillary Electrophoresis, LC-MS, Capillary IsoElectric Focusing, ELISA, HPLC/ UHPLC, UV spectroscopy, and higer-order structure method</span></li><li style="text-align: justify;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt; color: #000000;">Experience of working in a CRO environment with knowledge of GMP regulations</span></li></ul><p style="margin: 0in 0in 0pt;"><span> </span></p>