Senior Assay Development Scientist - Stirling

Scientific and Drug Discovery - Other
Ref: 984 Date Posted: Monday 21 May 2018
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Senior Assay Development Scientist

Permanent Opportunity

Location – Stirling, Scotland   

This is an opportunity to work with an exciting, energetic and growing IVD organisation.  They have an excellent culture which is made of a team of proactive, talented, focused and enthusiastic individuals and are always looking for like-minded individuals to join their thriving team.

If you feel that you offer the same attributes and you would like to make a significant contribution to the continued growth and success of the company, then please get in touch today.

As a Senior Assay Development Scientist you will be responsible for key components in the development of Diagnostic assays. You will have people management and development responsibilities within a project.

Role Responsibilities:

  • Lead the development of significant project activities to ensure robust assay performance such as

                  On Board Control Systems

Liquid Controls

Shelf Life Assignment

Pre Validation and Verification

  • Design and execute appropriate experiments for the purpose of assessing and improving the assay to meet the required performance, stability and cost requirements.
  • Use statistical methods to design and analyse experiments and make the appropriate scientific conclusions and define next steps required.
  • Ensuring that the developed assay and its components are capable of meeting the required performance, stability and cost requirements for the assay platform.
  • Solve problems encountered during assay development innovatively and independently.
  • Writing and communicating project updates within the organisation.
  • Ensuring Design Control procedures are adhered and that reports and procedures are written.
  • Create and maintain quality records for the purpose of assessing and improving assay methodologies and documenting experiments.
  • Ensuring you are trained on all appropriate procedures and training new personnel if and when required.
  • Technically reviewing change controls and peer reviewing laboratory note books.
  • Ensuring you work in conjunction with the quality policy and objectives.
  • Manage and develop scientists and technicians within the team.
  • Lead cross functional engagement in solving complex problems encountered during product development.

About You

Essential Skills:

  • Degree Qualified in a relevant Scientific Subject.
  • Line Management experience.
  • Knowledge and understanding of factors which drive assay performance (including sensitivity, range, stability, reproducibility and precision).

Desirable Skills:

  • Experience of using particle-based immunoassays
  • Knowledge of reagent/conjugation chemistry.
  • Knowledge of validation and verification planning and testing
  • Experience in Design of Experiment and application to product development
  • Experience of GMP / GLP / GDP standards
  • Experience and understanding of factors important in reagent preparation and drying for use in POC immunoassays
  • Experience working in the IVD industry, and having launched IVD products.
  • CE marking IVD products, 510K submission and approval process.
  • Application of 6-Sigma within an R&D setting.
  • Knowledge and experience of working within a biohazard environment

Further Details

Our client is offering a competitive salary in a great working environment therefore if you are looking to further develop your career with a thriving and growing company, this could be the role for you.

For more information, please call Suzi on 01224 608988 or e-mail a CV to suzi@entrustpeople.co.uk