STEM Recruitment is working with our client, a medical technology company who are leading innovators within their industry. They develop, manufacture and commercialise diagnostic platforms.
We are currently recruiting for a Reagent Manufacturing Scientist to work within our reagent manufacturing department. You will work within a team of technicians and scientists in a GMP environment to facilitate the validation and transfer of new process and test methods from development into the manufacturing department. You will also provide support where required to manufacture and test reagents for commercial sale and related validation activities. You will be part of the manufacturing team but will also be required to work in collaboration with the development transfer team, acting as trainer for the new processes to be implemented. You will be responsible for Reagent Manufacturing Technicians and will report into the Reagent Manufacturing Team Leader.
* Provide feedback and evaluation support to R&D to aid delivery of suitably robust processes and test methods.
* Support the purchasing of appropriate equipment and the validation activities for the manufacture and testing of reagents.
* Ensure raw material and consumable availability for new processes, creating documentation where required and communicating with Supply Chain
* Support the design, execution and analysis of experiments for improving reagent manufacturing operations.
* Work in collaboration with transfer team to introduce new processes to manufacturing and role out effective training
* Prepare process buffers and stock solutions to allow reagent manufacturing and validation schedule to be met.
* Manufacture assay reagents safely, efficiently in line with schedule and current SOPs and WIs to meet strip production requirements.
* Evaluate performance of raw and in-process materials at critical stages of manufacture and carry out final formulation testing.
* Schedule routine calibration, maintenance and running of laboratory and analytical equipment and support external supplier maintenance activities as required.
* Responsible for upload of real time material and labour data into ERP system
We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in problem solving and a can do attitude, along with the following experience:
* Degree level qualified, or equivalent, in a science subject. Significant relevant experience may also be considered without a degree.
* Experience working within a manufacturing laboratory following good lab practices and confidence to work without supervision
* Ability to create and follow complex protocols and accurately complete batch records
* Knowledge of in-process testing such as electrochemical, fluorescent and particle analysis methods (e.g. Flow Cytometry, Dynamic Light Scattering).
* Can work well within a group environment
* Knowledge of GMP standards, including Validation protocols and Non-Conformances
* Good communication, personal task management skills and high self-motivation
* Good at problem solving and troubleshooting
* Computer literacy, data analysis interpretation skills and good attention to detail
* Experience of working within a biohazard environment
* Commercial diagnostic assay experience
* Experience in statistical analysis techniques
* Line management experience
* Six Sigma Green Belt or Black Belt Qualification
- Raw Materials
- Good Manufacturing Practices