Reagent Manufacturing Analytical Scientist

Job Description

OverviewReagent Manufacturing Analytical ScientistA rare opportunity to join a busy, friendly reagent manufacturing team on a shift basis! Be part of a fast growing and vibrant company, working with ground breaking technology to make a real difference to peoples lives! Highly competitive salaryon offer and great potential for advancement.Key Responsibilities:

• Evaluate performance of raw and in-process materials at critical stages of manufacture and carry out final formulation testing to support manufacturing activities, work to established test specifications.
• Prepare process buffers and stock solutions to allow reagent manufacturing, testing and validation schedule to be met.
• Support preparation and manufacture of assay reagents safely, efficiently and in line with schedule and SOPs/WIs to meet strip production requirements.
• Carry out routine calibration, maintenance and running of laboratory and analytical equipment and support external supplier maintenance activities as required.
• Support the purchasing of appropriate equipment and the validation activities for the manufacture and testing of all reagents.
• Ensure raw material and consumable availability for new test methods, creating documentation where required and communicating with Supply Chain
• Execute validation and ongoing monitoring of analytical test methods and equipment.
• Support development and transfer of new analytical test methods for raw materials, intermediates and final manufactured assay reagents.
• Schedule routine calibration, maintenance and running of laboratory and analytical equipment and support external supplier maintenance activities as required.
• Adhere to all relevant regulatory GxP requirements.
• Lead in the creation and update of SOPs/WIs as required
• Ensure creation and update of COSHH assessments, acting as technical review, and follow and comply with all relevant internal quality and H&S processes and procedures.
• Raise Non-conformances, lead investigations and corrective actions and support other team members.
• Accurately complete batch records and reports, recording and communicating all process observations and deviations.
• Technically review process documentation and reports, and provide feedback to team members to support a Right First Time culture.

About you:Essential Skills:

• Degree level qualified, or equivalent, in a science subject including Analytical Chemistry.
• Experience and strong knowledge of HPLC/UPLC, FCM, DLS, Rheology, MS, UV/Visible spectrophotometry, and related wet chemistry techniques.
• 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.
• 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.
• Knowledge of GMP standards, including Validation protocols and Non-Conformances.
• Ability to work 12 hour shifts to support 24/7 manufacture.

Desirable Skills:

• Experience of working within a biohazard environment.
• Commercial diagnostic assay experience.
• Experience in statistical analysis techniques.
• Six Sigma Green Belt or Black Belt Qualification.
• Knowledge of Nanoparticles and Antibody Conjugates.

Next Steps:Apply online in the first instance, or contact Liam Baxter at Tel: or email your CV toEqual Opportunities:FPSG is committed to equal opportunities regardless of gender, race, disability, sexual orientation, religion or belief and age.We are Disability Confident and neurodiverse aware. If you have a disability, please tell us if there are any reasonable adjustments we can make to assist you in your application or with your recruitment process