Working as part of the Molecule Management Group, the Lead Scientist (LS) routinely manages large, multi-technique projects. In this role, the LS will provide internal and external Clients with a central scientific point of contact for projects within BioPharmaceutical CMC Solutions – Large Molecules (BioCMC). The individual 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 PMO, 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 LS 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 LS 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 fulfils the protocol design and all regulatory expectations. The LS 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 PMO. The LS 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). There is an expectation that the senior members of the Molecule Management team will be required to travel to visit clients and attend conferences, and represent Covance by preparing and/or giving presentations and writing scientific papers. The post holder will report to the manager of the Molecule Management group on a daily basis (a permanent change of supervisor will be documented in training records). The post holder will ensure adherence to the BioCMC SOPs and will be responsible for completion of all relevant documentation.
• The post holder should ideally have a relevant degree. • A working knowledge of a wide range of CMC analytical techniques • Working knowledge of statistics and it’s application to techniques and 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. • Knowledge of capabilities and expertise of the Covance organisation and companies that may provide support services. • Commercial awareness, interpersonal and negotiating skills. • Learn and maintain knowledge of process excellence processes, tools and activities.
The post holder should typically have: • A Scientific degree BSc and relevant industry experience / PhD and relevant industry experience in CMC Drug Development. • Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages and Microsoft Project). • An in-depth understanding of health and safety policies, Company policies and procedures, and an in-depth understanding of the GxPs • The post holder should be able to communicate effectively at all levels with other Covance employees, as well as external clients, suppliers, etc.