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 Senior Technician to work within our reagent manufacturing department. You will work within a team of technicians and scientists in a GMP environment to manufacture reagents for commercial sale and related validation activities. Manufactured reagents will be used to produce test strip devices for a wide range of assays. You will be responsible for the ongoing manufacture and testing of reagents and related components to ensure the supply of consistently high quality reagents to meet production requirements, while maintaining a compliant GMP laboratory environment.
* Report into Scientist daily for prioritisation of tasks and assist with communication and scheduling to Technicians
* Ensure raw material and consumable availability through routine stock checks and requisitions, communicating with Supply Chain and creating documentation where required.
* Prepare process buffers and stock solutions to allow reagent manufacturing schedule to be met.
* Real time data entry of material usage into electronic trackers to maintain accurate stock levels and departmental costings.
* Manufacture assay reagents safely and efficiently in line with schedule and current SOPs and WIs to meet strip production requirements.
* Ensure Technicians on processes are trained to perform activities prior to execution
* Ensure manufacturing area is maintained to the required standard through execution of defined cleaning procedures as scheduled
* Evaluate performance of raw and in-process materials at critical stages of manufacture and carry out final formulation testing.
* Carry out routine calibration and maintenance of laboratory and analytical equipment, and arrange maintenance activities with external suppliers and engineers where required.
* Raise Purchase Orders for new equipment, repairs and services as needed and coordinate suitable delivery the department.
We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in problem solving and people development, along with the following experience:
* Previous experience working within a scientific manufacturing or laboratory environment
* Knowledge of GLP and GMP standards including Non-Conformances
* Confidence working with minimal supervision in a laboratory environment and adhering to EHS standards
* Ability to follow complex protocols and accurately complete batch records
* Experience of accurate electronic data entry
* Good at problem solving and troubleshooting
* Computer literacy, data analysis interpretation skills and good attention to detail
* Good communication, personal task management skills and high self-motivation
* Can work well within a group environment and act as a trainer to others
* Degree level qualified, or equivalent, in a science subject
* Commercial diagnostic assay, or similar industry experience
* Experience of working within a biohazard environment
* Experience using electronic QMS and Purchasing systems
- Raw Materials
- Biochemical Assays