Qualified Person - Biotech

Job Type:
Permanent
Job Sector:
Scientific
Region:
South East
Location:
Stevenage
Salary:
£85,000 to £85,000 per annum
Salary Description:
Up to £85,000 D.o.E. + 10% bonus & excellent benefits
Posted:
27/04/2018
Recruiter:
SLS Services Limited
Job Ref:
15854 JH

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 of grade comprise of 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.

Experience
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. 

Contact Details:
SLS Services Limited
Tel: +44 1403 216200
Contact: James Hume
Email:

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