Qualified Person - Biotech, Stevenage

Qualified Person - Biotech, Stevenage

Job Title: Qualified Person - Biotech, Stevenage
Contract Type: Permanent
Location: Stevenage
Salary: Up to £85,000 D.o.E. + 10% bonus & excellent benefits
Start Date: 2018-04-27
Reference: 15854 JH
Contact Name: James Hume
Contact Email:
Job Published: May 10, 2018 17:53

Job Description

James Hume is currently recruiting for a Qualified Person to join a unique Cell and Gene Manufacturing centre that is pioneering the way for the production of these therapies for use in clinical trials.  Providing solutions to the challenges that many companies face whether these be logistical or skills wise so that these life changing therapies can come to the market.  The manufacturing facility is a new site of a well-established biotech that is headquartered in central London.  They are a centre of excellence supporting academia and industry to help commercialise therapies, crossing the translational gap, through clinical trials to reach the market.

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.  They collaborate with both academia and industry and they are able to provide the scientific, clinical and commercial expertise needed to overcome the challenges that hinder the commercialization of these fast developing, cutting edge technologies.  Their longer-term aim is to make the UK a global leader in the development and commercial exploitation of therapies. To meet this aim they have constructed a purpose built manufacturing centre which opened at the end of 2017 and immediately after opening additional funding was allocated for the centre to be doubled in size due to the demand for their services.  The site contains state of the art equipment and offers the flexibility to meet collaborators needs covering manufacturing, quality, storage and distribution functions.  Comprising Grade A / B clean rooms, QC laboratories, warehousing, dispatch, along with segregated client production and business offices covering 7,200 m2.

The Role
The role of Qualified Person is a strategic position at this groundbreaking facility where you will have influence on securing an MHRA license overcoming the issues they face because of their unique situation.  They offer a multi-use, multi-client site for companies with whom they are in collaboration with where they can take control of individual modules.  Where companies can bring their own QMS and technology to manufacture therapies for use in clinical trials in the UK and EU.  Thus, the initial focus will be on developing a fit for purpose QMS and providing technical expertise to both the company and collaborators including on a QP to QP basis.

The manufacturing centre is operational which means there will be the responsibility for performing batch release certification for manufacturing activities of ATMP.  Working closely with collaborator QP’s, some of whom will be on site.  As well as ensuring the centre continues to apply to GMP regulations at all time, work closely with regulatory bodies, be a key point of contact for collaborators and lead inspections.

Due to the positioning of this role, you will be working closely with the MHRA to ensure ongoing compliance.  What makes it stand out is the chance to be a part of the senior management of this site and drive it forward as it continue to expand.  Leading this from a quality perspective working very closely with the Head of QA as the site reaches its full potential.

You must be able to act as a Qualified Person under Directive 2201/83EC and have experience of working in the Biologics, or Biotech, or Cell & Gene therapy sectors.  Strong experience of microbiology functions is a definite advantage as this is one area where they will need expertise as this function is set up and implemented.