Associate Scientist Analytics - Cell and Gene Therapy, Open to flexibility

Stevenage, Hertfordshire
14 Sep 2018
28 Sep 2018
Contract Type

Associate Scientist Analytics - Cell and Gene Therapy, Open to flexibility

GSK's Cell & Gene Therapy Platform CMC team is being expanded to support an increasing portfolio of cell and gene therapies.
The team is responsible for delivering the Chemistry, Manufacturing and Controls (CMC) aspects of the projects from early phase to launch and the development of innovative technologies to enable step-change improvements to cell & gene therapy manufacture.

GSK has a significant collaboration in the T cell immunotherapy field with Adaptimmune and other licensing/partnership opportunities are being pursued.

The progression of our own portfolio together with the maturation of emerging gene therapy technologies creates an imperative for GSK to now increase our investment in this space and establish an end to end leading platform.

This will facilitate delivery of the portfolio in Oncology as well as ensuring that GSK is able to capture the potential of the emerging technologies in other therapeutic areas.

A key CMC challenge in this endeavor is the development of suitable analytical methods that can support both process development and manufacturing of cell and gene therapy products. The successful candidate will join an analytical development group that is currently expanding in the UK and USA and will have the following responsibilities:::

  • Development of analytical method and transfer to internal Product Development and QC laboratories, and CMOs or testing laboratories
  • Perform analytical testing to support process development
  • Support laboratory and equipment maintenance
  • Support external collaborations to enhance our analytical capabilities and enable the future vision of a robust and rapid testing strategy for cell and gene therapy products
  • Participate in risk assessments to develop robust product control strategies for cell/gene therapy programs
  • Executes and write up scientific experiments in a timely manner and with high quality
  • Support training of colleagues in QC and Product Development
  • Interact with third parties and testing laboratories.

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.

If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.The information that you have provided in your cover letter and CV will be used to assess your application.

Thank you for your interest in this opportunity.

Closing date for applications: 28th Sept 2018


Why You?

Basic qualifications:

  • BSc in biology, cell biology, virology, biochemistry or related scientific discipline
  • Experience in analytical method development
  • Strong organisational and excellent interpersonal communication skills
  • Demonstrated excellence in technical writing skills
  • Demonstrable ability to work in multi-disciplinary, multi-cultural teams

Preferred qualifications:

  • Experience in analytical development in support of recombinant viral vector production and T-cell therapies
  • Experience in the development of cell-based and molecular biological analytical methods to characterise viruses and cells such as flow cytometry, clonogenic potential assays, imaging, qPCR and ddPCR
  • Experience of vaccines, biopharmaceutical or cell and gene therapy product development
  • Knowledge of QbD approaches to analytical method development including risk assessment, DOE and statistical analysis
  • Experience of investigations into out of specification, out of trend or process deviations including root cause analysis, impact assessment and development of appropriate corrective and preventative actions
  • Experience generating regulatory documentation
  • Experience in analytical method transfers and control strategy development

Why GSK?:

GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery for strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.

Contact information:
You may apply for this position online by selecting the Apply now button.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.