Working as part of the Molecule Management Group, the Senior Scientist routinely manages large, multi-technique projects. In this role, the Senior Scientist will provide internal and external Clients with a central scientific point of contact for projects within BioPharmaceutical CMC Solutions – Large Molecules (BioCMC). Our BioPharmaceutical CMC Solutions group in Harrogate, UK has 250 total staff. The majority of our analytical staff is educated to degree level and most senior staff have second degrees. The level of experience in the analytical team ranges from new hires to senior analysts with over 20 years of experience. This group has more than 700 cumulative years of GMP experience. The Senior Scientist is accountable for leading the scientific teams to ensure that Client requirements and deliverables are met. This involves discussion with the Client to design proposals, working with the Project management department, communicate with the QC section managers and oversight of scientific progress of projects to ensure the successful, initiation, planning, execution, monitoring and completion of projects. The primary responsibilities will be to navigate the regulatory framework to ensure that the client programs are conducted to meet the defined milestones along the drug development pathway with scientific integrity. The Senior Scientist is expected to have a working knowledge of all methodologies for a client project. They will write protocols and reports using the QC scientist approved data that fulfills the protocol design and all regulatory expectations. The Senior Scientist will be required to communicate with internal and external project teams, departmental management and the client to ensure effective scientific progress throughout the life cycle of a project in partnership with the Project Management Organisation. In this role you will be expected to communicate the scientific and regulatory framework of a project that builds a team to understand and delivers the drug development milestones. The individual will identify and communicate scientific and regulatory developments to the molecule management team and the wider senior scientific group (Method Development and QC Scientists). You will report to a Senior Lead Scientist on a daily basis. This role will be office based in Harrogate, UK.
Typically be educated to a Bachelor/Master/PhD degree within life-sciences or equivalent.
Excellent understanding of drug development. A working knowledge of a wide range of CMC analytical techniques (For example ELISA, cell culture, FACS, HPLC, protein extraction, SDS-PAGE, Western Blotting, Capillary Electrophoresis, Isoelectric Focussing, Biosimilairs and mass spectrometry) Working knowledge of statistics and its application to techniques Regulatory applications (validation, equivalence) The ability to get things done by influencing others (both internal and external). An up to date knowledge of regulatory guidelines and their application. Commercial awareness, interpersonal and negotiating skills. Learn and maintain knowledge of process excellence processes, tools and activities. Excellent organisation and communication skills Previous experience from a similar role working with Large molecules would be highly beneficial.