Reagent Operations Technician at Roche

Job Purpose

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. Support the validation of new assays into manufacturing that meet Design for Manufacture requirements and ensure consistently high quality. Perform ongoing process improvement activities for existing assays.

The Opportunity:

You will work within a team of technicians and scientists in a GMP environment to manufacture reagents for commercial sale and facilitate the validation and transfer of new processes and test methods from development into the manufacturing department. You will be part of the manufacturing team but will also be required to work in collaboration with the development team. Manufactured reagents will be used to produce test strip devices for a wide range of assays on the LumiraDx platform.

This is an on-site position based at our current location: Athena Motherwell. Please note that you would be required to travel to the other site (in Tullibody) occasionally.

This is a full-time role requiring availability for rotating shifts (Shift A, B, C), Monday to Friday (with limited work on the weekends). The shift pattern is as follows:

• Day shift: 7:00-19:00 (Monday to Thursday), Fridays: 7:00-16:30
• Night shift: 19:00-7:00
• Sundays: 19:00-7:00

Candidates must be able to work both early and late shifts as part of a rotating schedule.

Responsibilities: 

•  Ensure raw material and consumable availability and 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, current SOPs and WIs and validation protocols to meet strip production requirements. ·
• Evaluate performance of raw and in-process materials at critical stages of manufacture and carry out final formulation testing. ·
• Carry out routine calibration, maintenance and running of laboratory and analytical equipment and support external supplier maintenance activities as required. 

Quality / Regulatory Compliance

• Adhere to all relevant regulatory GLP, GMP and GDP requirements. 
• Assist with the creation and update of SOPs/WIs as required. ·
• Create and update COSHH assessments and follow and comply with all relevant internal quality and H&S processes and procedures. 
• Accurately complete batch records and reports, recording and communicating all process observations and deviations. 
• Raise Non-conformances and support investigations and corrective actions.

Who you are:

• A degree-level qualification in a science subject is desirable, but equivalent relevant laboratory or scientific manufacturing experience will also be considered.
• Experience working within a laboratory environment or similar scientific manufacturing industry.
• Confidence working independently with minimal supervision in a lab environment.
• Ability to follow complex protocols and accurately complete batch records.
• Strong problem-solving and troubleshooting skills.
• Computer literacy with data analysis and interpretation skills.
• Attention to detail, good communication, and personal task management skills.
• High self-motivation and ability to work well within a team.
• There is a requirement for the successful applicant to have a driver's license and access to a car.

Desirable:

• Knowledge of good laboratory practices, GMP standards, validation protocols, and handling Non-Conformances.