|Job Ref:||EMP362245||Employer:||Matchtech Group plc.||Country:||United Kingdom||City:||Huntingdon||Address:||Post Code:||PE29||Salary:||£45,000/year||Post Date:||14/10/2016 21:33|
Our client are leaders in their field and are looking to make a key addition to their Bioanalysis Group. The Team Leader/Section Head will be responsible for co-ordinating and leading a very busy group responsible for all non-regulatory work. |
Proven ability to lead a team. Expert in developing LC-MS/MS methods to support drug programmes.
As the Team Leader/Section Head you will take ownership of the management, scheduling and workload reviews of technical support for non-GLP work, and scientific troubleshooting for regulatory work, ensuring that the LC-MS/MS analytical methods transferred in, developed, validated and applied are fit for their intended purpose.
The work load includes supporting lead optimisation, PK screening, PK/PD studies, method feasibility and method development projects within Bioanalysis for LC-MS/MS determination using various sample preparation techniques (SPE, LLE, protein precipitation etc).
- Advance scientific and technical knowledge including analytical method strategies that programmatically address technical challenges.
- Recommend and drive new technology implementation in the department.
- Interact directly with internal partners to increase business profitability including Programme Management, Sales support and other operational lines (e.g. Tox, DMPK and Pharmacology).
- Keep abreast of bioanalytical regulatory guidelines and ensure that non-regulatory work is supported in an appropriate fit for purpose manner.
- Evaluate and implement applicability of LC-MS/MS beyond the traditional small-molecule domain such as the bioanalysis of Antibody-Drug-Conjugates (ADCs) and therapeutic peptides/proteins.
- Oversee planning of workloads, monitor analytical data generated.
- Ensure all work generated by the team is fit for purpose and complies the requirements of Clients.
- Responsible for ensuring accurate transfer of bioanalytical methods for validation, and check analytical data and method documents.
- Direct method development, lead in resolving analytical issues.
- Undertake the role of bioanalytical lead on analytical studies.
- Take responsibility for and deliver appropriate in-house training, develop and maintain training programmes for relevant individuals.
- Champion new initiatives and drive process improvement.
- Provide scientific, technical and managerial oversight to the non-regulatory analytical team; for example, in support of drug discovery and screening (deriving from in-vitro and in-vivo studies).
- Assisting with revenue recognition and forecasting, assisting in recruitment and salary reviews, leading performance reviews, overseeing business compliance and metric tool, driving Staff development.
- Act as a key contact for internal and external customers, ensuring that customers receive prompt and appropriate responses to enquiries and are regularly updated with study progress.
- Assist in client and regulatory inspections.
- Expert in developing LC-MS/MS methods to support drug development programmes and in supporting non-regulatory bioanalysis.
- Up to date knowledge of analytical methods and instrumentation used in bioanalytical laboratories.
- Demonstrable background in troubleshooting.
- Demostrable experience in the pharmaceutical, clinical or CRO industry with a thorough working knowledge of analytical methods and instrumentation.
- Experience of working in a non-regulatory and regulated environment to GLP (Good Laboratory Practice) and GCP (Good Clinical Practice) or other internationally recognised laboratory standards.
- BSc/MSc/PhD in Chemistry or possibly Biochemistry.
For more information please feel free to call NA.