Associate Director - Biotech QC

Associate Director - Biotech QC

Job Title: Associate Director - Biotech QC
Contract Type: Permanent
Location: Stevenage
Salary: Excellent salary and benefits package
Start Date: 2019-12-12
Reference: 46002 JH
Contact Name: James Hume
Contact Email:
Job Published: December 12, 2019 11:04

Job Description

A clinical stage cell therapy company are recruiting for an Associate Director to join their expanding QC team with the responsibility for overseeing the day to day operations.  With strategic input into the group’s development and expansion as therapies progress through trials and others enter the clinic.  As a company they are manufacturing therapies for phase I and II clinical trials with these moving to the later stages in 2020 with others under development to enter the clinic in due course.  They are developing cell therapies based on programmed T – Cells for the treatment of cancer, specifically haematological malignancies and solid tumours.  By engineering the T cells to be precisely targeted, controlled and active in targeting cancer cells, to then break down defences to eliminate them. 
As the Associate Director you will be leading teams of QC Scientists each with a Team Leader totalling 4 direct reports and total number of scientists of 24.  The teams are responsible for the testing of ATMP’s (plus raw and starting materials) ahead of batch release for use in clinical trials in compliance to GMP.   Your responsibility is to oversee the day to day operations to ensure these are complaint to GMP, and that testing is completed on time so that batches are released on time.  Plus driving the evolution of the group through continuous improvement and other initiatives. To complement the day to day operations you will be working with the QC Director to ensure that longer term strategic plans are developed and are in place so the group can keep expanding to meet the needs of the business.  There is excellent growth in the role to begin with before greater longer-term career prospects as the company are expanding rapidly going forwards meaning this is an excellent time to join.
Desired skills and experience: For this opportunity you will need to have management experience working in a GMP compliant QC environment within the biopharma, biotech, biologics, ATMP, cell therapy or other relevant environment.  With an understanding of the different techniques used in these environments for the analysis of products.  You will need to be educated to at least BSc level with a high qualification being advantageous but not essential.
This is an exciting opportunity for an experienced Quality Control scientist with experience of team leadership to join a growing QC Group.  They have the responsibility for the analysis and testing for the release of cutting-edge T- cell therapies for use in clinical trials.  They are a pioneering and ambitious Bio-pharmaceutical company who develop next-generation, programmed T-cell therapies to treat cancer. They have existed for 4 years and is very well funded, with a clear strategy and expansion plan for the next 3 years and beyond.  They have a pipeline of product candidates in development (for the treatment of haematological malignancies and solid tumours) and are increasing their GMP production capacity. Based in a state-of-the-art facility in Stevenage, Hertfordshire, you will join a team that is doing something genuinely meaningful.
They are now reshaping their QC Department by splitting it into smaller teams of 4 scientists plus a Team Leader meaning there are at least two positions available.  The purpose of the role will be line manage a team of 4 scientists (typically comprising of 1 senior scientist, 2 scientists and a technician) with the responsibility to supervise and monitor the quality of their work and compliance to GMP.  They will be performing the analysis of T – Cell products using cell-based methods, ELISA, Western Blotting and Flow Cytometry for example.  Conducting Raw Material, In Process and Batch Release Testing of therapies for use in Clinical Trials.
As their Leader, you will be involved in other activities beyond the day to day testing such as the transfer of methods into the team and department.  The qualification and validation of methods to ensure they are suitable for a GMP environment.  Design and execute stability programmes, support the QC Manager in the collection of data for departmental KPI’s.  This is a developmental role with the purpose of gaining exposure to new areas and training to move to a more senior role as they continue to expand.
Experience:  For this opportunity, you will need to have experience of working in a GMP compliant environment using analytical techniques for the analysis of biologics, antibodies, cell therapies, gene therapies or related products.  With the experience line managing a small team of scientists including their training & development, and GMP compliance.  Technically you will need to have experie3nce of mammalian cell culture, aseptic technique, cell-based techniques, ELISA, and HPLC for example.  You will need to be educated to at least BSc level in a relevant life science with a higher qualification and advantage but not essential.