Quality Control Specialist - Biopharmaceutical

Quality Control Specialist - Biopharmaceutical

Job Title: Quality Control Specialist - Biopharmaceutical
Contract Type: Permanent
Location: Stevenage
Salary: Up to £50,000 DOE plus excellent benefits package
Start Date: 2019-08-27
Reference: 16340 JH
Contact Name: James Hume
Contact Email:
Job Published: August 28, 2019 14:02

Job Description

This unique Biotech is recruiting for a Quality Control Specialist who will be responsible for the activities of their QC laboratories to ensure these operate to GMP regulations and company expectations.  The facility is based on Stevenage and operates on a multi occupancy basis with 6 clean room suites used to manufacture Cell & Gene Therapies in compliance to GMP.  The purpose of this site is to manufacture cell & gene therapies on a scale large enough for phase III clinical trials and is currently expanding to accommodate more collaborators.
Company Overview: 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.  They collaborate with both academia and industry and they are able to provide the scientific, clinical and commercial expertise needed to overcome the challenges of commercialising therapies.  The Stevenage site works on a multi – occupancy basis comprising of 6 clean room suites which are occupied by their collaborators to run their manufacturing operations.  Going forward this will be increasing from 6 to 12 clean rooms which you will support on relevant areas.  
Role Summary:  The purpose if the QC Specialist is to support the activities of the GMP quality control laboratories to ensure the site is operating to GMP as well as the expectations of collaborators and regulatory bodies.  The role holder reports to the Head of Quality Control and oversees the day to day operations of the environmental monitoring, microbiology, raw material & in process treating and batch release testing for example. 
This role requires you to be flexible to execute the project requirements and reporting so that the QC provisions is in line with each collaborator’s requirements.  Working closely with them toe stablish what is required and achievable to align with their own aims.  As the Specialist, you will lead the tech transfer validation and execution of routine analytical techniques in the laboratories.  With flow cytometry, PCR, and ELISA being the most commonly used.  As the Specialist, you will also lead service improvements to ensure the service provided is the best it can be, suggest new ideas, and use your expertise in a visible manner.
Experience:  You will need to be educated to at least MSc level, or equivalent, with experience of working in a microbiology, aseptic, or biomanufacturing environment that operates in compliance to GMP.  You will need to have experience of working in grade b / c clean rooms and be familiar with techniques such as FACS, ELISA, PCR, cell-based assays to provide support where needed such as troubleshooting.  Experience of dealing with clients and / or collaborators is advantageous to your application but is not essential.