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Head of Quality Control – Biotech GMP

Head of Quality Control – Biotech GMP

Job Title: Head of Quality Control – Biotech GMP
Contract Type: Permanent
Location: Stevenage
Industry:
Salary: Up to £80,000 plus bonus & excellent benefits
Start Date: ASAP
Reference: 15942 JH
Contact Name: James Hume
Contact Email: james.hume@nextphaserecruitment.com
Job Published: August 07, 2018 15:39

Job Description

James Hume is recruiting for a unique Head of Quality Control opportunity to join the senior management of a new cell & gene therapy manufacturing site in Stevenage built by a leading Cell and Gene Therapy R&D company at the end of 2017.  The purpose of this new site is to manufacture therapies on a scale large enough for phase III clinical trials working in collaboration with academia and industry to bring these cutting-edge technologies to the market.  They are seeking a Head of Quality Control to oversee the their new GMP QC laboratories as well as develop strategies going forward, especially as the site is to double in size due to success after its recent opening.

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 can 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.  They are making great strides towards this aim with therapies entering phase 2 clinical trials and building credible cases to be progressed to stage 3.  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 Opportunity:

The purpose of the Head of Quality Control’s position is to manage the new facility’s GMP QC laboratories and associated infrastructure, to ensure that the new manufacturing centre meets the expectations of key stakeholders, regulatory bodies and collaborators.  The site operates on a multi occupancy basis and because of working to this model and the manufacture of ATMP’s at a large scale the centre is setting the pathway for others to follow. 

The Head of Quality Control is responsible for not only the management of activities such as environmental monitoring, raw material, and in process testing, but also sample and LIMS Management.  With the responsibility for ensuring all areas are operating efficiently and in compliance to GMP.  So that an efficient, timely service is provided to collaborators that matches the high standards of the company.  This role includes outward facing responsibilities dealing with senior members of collaborators, representing the company and acting as a point of contact.

This opportunity has a strong strategic element as the site only opened recently with the need to evolve established processes to meet changing business needs.  In the longer term, you will be part of the senior management team involved in the project for the centre to doubling in size.

Experience:

You will need to have demonstrable experience of working at management level in Quality Control on a biopharmaceutical / pharmaceutical environment with the responsibility for managing and leading teams to ensure compliance to GMP is maintained.  If you have experience of working in a Biologics, Vaccine, Biopharma, or Cell & Gene Therapy environment then this is advantageous to your application.  You will need to be educated to degree level or equivalent in a relevant life science with experience of dealing with clients.  Due to the broad scope of this role you do not need to have in depth experience of each of these functions but you must be strong in Quality Control functions such as in process, raw material and other testing associated with manufacturing.