Planet Forward have been engaged by a global pharmaceutical brand based in Milton Keynes, to secure a QC Biologist to join them on a 12-month contract with potential extension.

Our client have are an established brand with a varied portfolio of prescription medicines, vaccines and animal health products. Today, they are building a new kind of healthcare company – one that is ready to help create a healthier future for everyone.

Purpose of Role:

As a QC Biologist you will support activities in the areas of qualification of critical reagents (biomaterials) used in Bioassays, such as ELISA coats, ELISA conjugates, reference toxins etc. You will also be required to support analytical method validation / improvements and method transfers for Biology and Microbiology labs between sites.

Responsibilities:

* Expertise in Immunology techniques such as ELISA’s, haemagglutination tests, antigen mass assay is essential.

* Understanding of microbiology techniques such as sterility test is beneficial.

* Validation of biomaterials used in in-process and final product testing.

* Biology/Microbiology method validation / improvements and test transfer between labs/sites.

* Drive change management for introduction of new / improved methods and validation of new equipment.

* Be able to produce technical documents such as protocols, testing and execution plans and final reports.

* Ability to work on several projects simultaneously and be able to prioritise.

* Reporting and communication of results to stakeholders. Liaise with several departments – technical support groups, QA, Regulatory to drive project completion and deliver on milestones.

* The candidate will be required to report all laboratory activities in a clear, organised manner, in the form of reports, following the standard operating procedures.

* Good understanding and ability to perform efficient lab investigations arising from deviations or invalid/atypical results.

* The candidate should be able to provide training to staff on test methods and equipment usage.

* Additionally, the candidate may be required to support laboratory investigations, perform troubleshooting exercises and participate in proof of principle studies.

* Reporting and investigation of OOS and OOT results, determine root causes and implementing effective CAPA actions.

Key Skills Required:

* Good understanding and working knowledge of GMP Quality Systems.

* Technical expertise in ELISA’s and other immunology techniques, including microbiology techniques.

* Minimum 5 years of experience with excellent understanding of testing within a laboratory environment.

* Good Protocol and Report writing skills.

* Ability to communicate concise technical information with clarity

* Degree in Biology/Microbiology – Desirable

If this is of interest, please get in touch for an informal and confidential conversation on (phone number removed).

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age