To perform general duties and project work within the relevant laboratory section of the Quality Control Department and perform as the technical lead for analytical and process development matters.
To lead the development, validation and transfer of analytical methods including qualification of analytical equipment in support of development activities. Develop novel methodologies to support new and existing manufacturing processes. Liaise with Innovations at early stage developments Support Evaluation of Test methods for Pipeline Products in conjunction with Innovations. Review legacy analytical methods and validate via protocols to ICH requirements. Support in Clinical Manufacture test method development and testing. Support in Process Validation Testing for new processes or optimisation of existing processes. Stability Testing of pipeline Clinical Batches and support for existing products and including development of test methods and execution. Determine equipment, consumable and resource requirements for new Analytical Methods and support in development of budget. Act as scientific interface between BTG and 3rd parties for technical discussions surrounding the development of new scientific techniques. Maintain and develop state of the art knowledge applicable to existing and future processes. Work across site functions to resolve issues and implement corrective actions. Represent the company at external seminars and supplier visits as required. Input into, maintain and ensure adherence to budgets. Assist in the development of regulatory strategies for product submissions. To follow health and safety guidelines as issued by the Company. Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BTG values. Carry out other reasonable tasks as required by the Line Manager.
The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.
Accountable to – Manager, QC & Microbiology Responsible for –Scientists as designated. Close interaction with technical lead peers and liaison with internal personnel at all levels of the business as required. Liaise with external personnel as required.
Education and Experience
Educated to degree level in an appropriate scientific discipline. Significant experience in a biopharmaceutical or closely related industry. Computer literate.
Skills and Attributes
Strong technical background with an excellent working knowledge of GMP, Quality and Regulatory understanding. Proven Line Management experience with the ability to engage and motivate a multi-skilled team to higher goals. Ability to communicate effectively at all levels. Ability to work under pressure and co-ordinate several activities concurrently. Logical and numerate with an aptitude for detail. A keen strategic thinker who is willing to apply new concepts and ideas to take the business forward. Remain flexible to meet specific project / business need.
Outward focused to ensure capability stays ahead of any opportunity