The Lead Scientist ensures that the studies are carried out to the required standards and that all work is conducted in compliance with applicable regulatory requirements, and specifically those regulations (GxP) specified in the study plans, protocols, or work agreements governing the work in which they are involved. The Lead Scientist serves as the main point of technical contact for analysts and clients and ensures that client deadlines are met. They are also responsible for the efficient completion of analytical procedures within the Biopharmaceutical CMC Solutions. The Lead Scientist is the primary point of study control and has overall responsibility for the scientific technical and regulatory conduct of studies allocated to him/her as well as for the approval of study data, interpretation, documentation and reporting of results. Close and regular liaison with the client is of primary importance.
The job role for the Lead Scientist at this level is gained through experience within the role but will still be carried out under the guidance, as necessary, of an experienced Lead Scientist or Manager. Direction of study types and volume of work will be assigned in accordance with the level of experience. The Lead Scientist will:
- Work closely with laboratory personnel to ensure that the study is performed in accordance with the study protocol and the Covance standard operating procedures to ensure that the study is performed to the required scientific and regulatory standards.
- Serve as an expert in one or more fo the following: protein chemistry, seperation science, analytical control strategy, or immunocheimcal analysis.
- Design and troubleshoot experiments, analyses and assays and perform hands-on activities as needed.
- Design study protocols and write study reports to meet client and regulatory requirements.
- Provide in-depth and up to date knowledge of GxP regulations as applicable; coordinate and manage organisation of multi-site studies.
- Hold ongoing study meetings and provide client feedback to team. Be aware at all times of study status and anticipate problems that may affect timing, quality, etc. and work with operations taking appropriate action to resolve such problems and prioritise analysis for clients. Be responsible for on time delivery targets (protocols/results/reports). Constructively participate in departmental meetings, team meetings, scheduling etc.
- Ensure that all study communication is documented and maintained and carried out to meet client requirements. Proactively manage client and study changes to meet timelines and ensure all changes (timelines/costs etc) are captured and communicated to business development and project management. Provide in-depth knowledge of relevant assays, advise internal / external clients on standard and novel study designs, and be aware of new technology development in order to look ahead to new assays or implementation. Serve as a back-up Lead Scientist as assigned to support additional projects.
- Perform tasks in the day-to-day running of BioCMC Operations as necessary.
- Ensure accurate and prompt completion of study timesheets, leave records, sickness certificates and overtime and expense claims.
- Author and approve analytical methods as needed.
- Technically review analytical data.
- Review and Approve GMP / non-GMP data reports, CofAs, Validation reports and protocols, Stability reports and protocols, Investigations, CAPAs, Quality Events, etc.
- Oversee development of novel assays and implementation of new technology.