MSAT Associate Scientist I/II Analytical
Speke, Liverpool
Job Description:
- Performance of routine commercial operations and non-routine analytical testing, such as projects and investigation to the required standard, with respect to documentation, good housekeeping, cGMP, EHS, time keeping, budgets and regulatory legislation.
- Laboratory maintenance - housekeeping self inspections and stock control - re-order schedules and communication with key suppliers
Laboratory documentation of results is accurate, neat and timely, to include investigations. - Assist in the review and approval of laboratory documentation
Liaise with functional groups both within and outside MSAT to ensure production goals are achieved and plans are established and executed to achieve product supply requirements on a 0-3 month horizon - Assist the Manufacturing Science and Technology Senior Scientist by working with other MSAT functions, to ensure that assigned testing and projects are completed within the required time frame by staff
- Ensure the Senior Scientist is fully aware of testing and project status
Provide technical support to production and quality groups during investigations - Liaise and coordinate MSAT activities, ensuring alignment with UK1 business objectives and needs
- Provide production technical support to maintain cGMP and production efficiency by assisting in the resolution of analytical and production problems
- Optimise production and analytical operations and provide process efficiency improvements via Operational Excellence tools and techniques
- Co-ordinate key site projects to implement new equipment, technology, analytical methods, processes or materials as required by the needs of the business aligned to the site objectives
- Transfer processes, analytical methods and technologies from process and/or analytical development, generate the appropriate technology transfer documentation and provide training to operations and management staff
- Develop cross-functional skills for those joining MSAT from functional departments such as manufacturing, quality assurance, engineering and quality control
- Ensure the Quality Systems metrics associated with MSAT activities are maintained within agreed limits according to the site key performance indicators
- Provide technical training and underpinning knowledge training to manufacturing department to improve process and analytical knowledge, and understanding of the manufacturing operators
- Represent the company at regulatory inspections (including FDA & MHRA) and respond to questions
Position Requirements:
- To have a minimum of science degree or equivalent in Biochemistry, Microbiology, Molecular Biology, Virology or other science related field, or a degree in Biochemical or Chemical Engineering
- A MSC is advantageous but not essential
- Good experience in the bio manufacturing industry is essential
- A background in Virology, Immunology, or Molecular Biology with analytical development experience is advantageous
- A background in biological process/analytical technology transfer and investigation
- The job holder must be capable of making detailed observations, analysing data and interpreting results
- The job holder must be capable of making independent decisions and/or in collaboration with others and will be expected to exercise judgement and decisiveness
- The job holder will be expected to participate in inter-company and cross site meetings and requires the ability to liaise at all levels.
- This is a rewarding and challenging development role within a commercial setting. The role holder must be able to perform under pressure and be prepared to deliver against tight deadlines.
Additional Notes:
Good knowledge and experience with analytical testing requirements of biological manufacturing processes- Knowledge of ICH guidelines and experience in analytical validation (desirable but not essential)
- Knowledge of cGMP, in particular manufacturing and/or laboratory practices and quality systems
- Good knowledge of production equipment, facilities, engineering and instrumentation
- Knowledge of analytical development, including DoE and statistical analysis
- Strong organisational and interpersonal skills
- Good Project Management and prioritisation skills (desirable but not essential)
- Strong technical protocol and report writing skills and excellent communication skills
- Experience with specifying and validating instrumentation (desirable but not essential)
- Life virus experience preferable
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