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Quality Control Specialist - Microbiology

Quality Control Specialist - Microbiology

Job Title: Quality Control Specialist - Microbiology
Contract Type: Permanent
Location: Stevenage
Industry:
Salary: £45000 - £55000 per annum, Benefits: bonus, pension, life insurance, health insurance and other flexible benefits
Start Date: 2020-02-26 00:00:00
Reference: V-46100
Contact Name: James Hume
Contact Email: james.hume@nextphaserecruitment.com
Job Published: February 26, 2020 15:03

Job Description

A cutting-edge biotech who are leading the way in the commercialisation of cell & gene therapies are recruiting for a Quality Control Specialist to lead the Microbiology activities for their laboratories to ensure this is in line with collaborator requirements and GMP.  This is a multi-occupancy facility with the company providing the facilities to collaborators for them to manufacture therapies in compliance to GMP for use in  clinical trials. 

The Company
The company are a centre of excellence that is at the forefront of creating a viable and sustainable cell and gene therapy industry.  Their headquarters are in central London where they have built a leading multidisciplinary team that has the ability to take a therapy from concept through the development cycle to the market.  With sector leading expertise to overcome the challenges face commercialising these therapies providing the scientific, clinical and commercial expertise needed to overcome the challenges.  Once therapies have crossed the translational gap they have the capabilities to successfully complete non clinical studies to then take therapies through clinical trials with therapies now entering phase III trials.  

Role Purpose:
The role of the Quality Control Specialist is to be the subject matter expert for their for their Microbiology and Environmental monitoring provision to ensure this is compliant to GMP and meets the needs of collaborators. 

This role is broad with the responsibility for day to day interaction with collaborators in the facility as well as internally and has a responsibility for covers the Quality Control services they provide from a Microbiology perspective.  Which is across all their laboratories that provide in process, final product, raw material testing and sample processing.  You will be responsible for overseeing the day to day routines for microbiology and environmental monitoring to ensure these are carried out and in compliance to GMP. 

As this is an influential role for the site you will also have responsibility for supporting the continuous development of their services and the recent expansion of the site.  Working on special projects to support this alongside your day to day work that range form improving the microbiology function as well as others such as QMS, strategy, and continuous improvement. 

Desired Skills and Experience:
For this opportunity you will need to have experience of leading microbiology in aseptic biologics, biopharmaceutical or similar manufacturing environments working in compliance to GMP.  With experience of leading microbiology and environmental activities, dealing with regulatory bodies and managing compliance.