The Biopharmaceutical CMC Solutions Division of Covance, situated in Yorkshire was established over 20 years ago and is afully GMP/ GLP/ GCP compliant facility providing acomprehensive portfolio of services, includingextensive protein chemistry capabilitiesfor support of method development/ validation, characterisation, cGMP batch release and stability testing.

Recent investments have been made in facilities and successful candidates will be part of out exciting and expending future, workingalongside talented scientists, withinventive technologies and a progressivemanagement team.

Biopharmaceutical CMC Assay Development Scientist

The Biopharmaceutical CMC Solutions team isfocused on providing analytical support in the drug development pathway for the characterisation and stability assessmentof large protein molecules including: vaccines, antibodies, cytokines and growth factors. The accurate characterisation of a drug is necessary to release manufactured batches ofthe drug, assess stability (shelf life) and evaluate the impact of changes in manufacturing process or in formulation. This is achieved using a variety of analyticaltechniques such as: HPLC/ UHPLC, Capillary Electrophoresis, UV spectroscopy, ELISA andmass spectrometry.

Working within a dedicated BioCMC assay development team, the successful candidate will be involved in the development of analtical workflows and will be primarily responsible for characterisation studies, assay establishment/ team training and assay validationprior to cGMP batch release and stability studies. The Subject Matter Expert willliaise closely with QC Scientists and those who have overall responsibility for the scientific, technical and regulatory conduct of these studies.

The role will primarily be laboratory based andresponsibilities will include:

• The development, establishment and validation of analytical workflows and methods; interpreting and documenting data, method related software customisation,and reporting of results.
• Provision of scientific expertise; able to give technical advice to internal external clients and guide decision making or trouble-shooting processes.
• Documentation of studies to the required scientific and regulatory standards, and in accordance withstudy protocol and Covance standard operating procedure.
• Understanding of client requirements (i.e. critical aspects) and planning accordingly to deliver targets on time and within budget and to manage study changes.
• Anticipation of problems that may affect timing or data quality, taking appropriate action to minimise impact or resolve issues.
• Networking between departments to meet the demands of multi-disciplinary client programs.
• Where appropriate, publish and present at conferences and symposia, etc.

Education/Qualifications:

• The successful candidate is expected to have a relevant scientific degree and an appropriate amount of laboratory experience. A PhD in a relevant field would also be of advantage for this position.

Experience:

• The candidate will have aminimum of3 years experience working with biopharmaceutical products in a CMC environment.
• Expertise is multiple analytical techniques is required, including Capillary Electrophoresis, Capillary IsoElectric Focusing, HPLC/ UHPLC, UV spectroscopy, ELISA, Surface Plasmon Resonance, SEC-MALLS, DLS, CD and DSC.
• Experience inmolecular biology, virology and in working with Gene and Cell Therapy products would be an advantage.
• Ideally the the candidate will also have experience of working in a CRO environment with knowledge of UK/ OECD GXP regulations.