Reagent Manufacturing Analytical Scientist

CK Group are recruiting for a number of Reagent Manufacturing Analytical Scientist for a rapidly growing research and development company. The Reagent Manufacturing Analytical Scientist will be working at the site near Stirling on a full time, permanent basis. This client is offering an opportunity to be involved in transforming In Vitro Diagnostic testing and provide next generation healthcare.

Reagent Manufacturing Analytical Scientist Role:
As Reagent Manufacturing Analytical Chemist, you be responsible for implementation and validation of new analytical test methods into the manufacturing department for all reagent manufacturing materials that relate to final product performance and provide understanding of the Critical to Quality elements of reagent manufacture. This is to achieve the consistently high quality required for reagent progression to Production and ensure they meet the Design for Manufacture requirements.

Further responsibilities will include to:

- Ensure raw material and consumable availability and prepare process buffers and stock solutions, to allow reagent.
- Work with R&D to identify, develop and transfer relevant and robust analytical test methods for raw materials, intermediates and final manufactured assay reagents.
- Establish test specifications for critical raw materials and stages of manufacture that are final product performance impacting.
- Perform full validation on analytical test methods and plan ongoing monitoring.
- 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 test methods, creating documentation where required and communicating with Supply Chain.
- Support the design, execution and analysis of experiments for improving existing reagent manufacturing test methods.
- Work in collaboration with transfer team to introduce new tests to manufacturing and roll out effective training.
- Prepare process buffers and stock solutions to allow reagent manufacturing, testing and validation schedule to be met.
- Evaluate performance of raw and in-process materials at critical stages of manufacture and carry out final formulation testing to support manufacturing activities.
- Schedule routine calibration, maintenance and running of laboratory and analytical equipment and support external supplier maintenance activities as required.

Your Background:
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

- Degree qualified in a relevant scientific discipline 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.
- Knowledge of GMP standards, including Validation protocols and Non-Conformances.
- Computer literacy and data analysis skills.

Apply:
For more information or to apply for this Reagent Manufacturing Analytical Scientist position, please contact Natalie Wood at CK Science on 01246 457723 or email nwood@ckscience.co.uk, quoting job ref 48564.

It is essential that applicants hold entitlement to work in the UK.

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