Reagent Manufacturing Analytical Scientist

3 days ago

Motherwell, United Kingdom FPSG Connect Full time

**Overview**

**Reagent Manufacturing Analytical Scientist**

**A 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 people's 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**:

- 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**:
**Equal Opportunities**:
FPSG is committed to equal opportunities regardless of gender, race, disability, sexual orientation, religion or belief and age.

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