Senior Scientist, Quality Control (Open to flexible working)
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines a talented workforce and technical resources to create a platform for the delivery of 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.
The CGT platform unit within GSK is an integrated discovery-development-supply unit which will ensure that ground-breaking CGT medicines are seamlessly and expertly discovered and manufactured for clinical development and beyond. 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 enable 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.
The CMC capabilities to develop and deliver these products are being built within the Cell and Gene Therapy Platform. As part of the expansion of this platform, the Cell and Gene therapy Quality control team needs to increase capacity to support delivery of quality products to the patient.
- Contribute to the quality control aspects of product development within GSK and with collaborators and third parties
- Lead, support and perform validation and routine analytical techniques used for the testing and release of cell and gene therapy products, including flow cytometry, qPCR, ddPCR, ELISA etc.
- Support, involve and work with technology transfer team to ensure successful transfer and ongoing performance of analytical methods
- Act as Subject Matter expert for equipments, system assigned
- Co-ordinating, Authoring and implementing local quality systems
- Work with Quality Control, Validation and Quality assurance team to validate equipment and IT systems
- Author/review analytical method, Equipment and laboratory systems ensuring alignment with GSK standards
- Ensure that any analytical non-conformance or OOS are highlighted to management and investigated.
- Product Quality and Compliance for Cell and Gene Therapy products under development and in commercial supply within GSK or at third parties
- Ensuring local compliance with QMS, Pharmacopoeia and Regulatory Guidance
- Quality Control of gene therapy products within GSK or at third parties
- Ensure analytical methods are fit for purpose through method qualification and validation activities
- Participate in equipment and IT systems validation activities
- Lead, participate in the investigation or review of change controls, quality deviations and out of specification results
- Compliance with regulations, guidelines and best practice
- Manage data in appropriate systems to ensure compliance and data integrity.
The role will be based in the UK with the Cell and Gene Therapy Product Development and Supply group at Stevenage. European and international travel will be required at times, as dictated by the project needs.
Closing date for applications: Wednesday 25th April 2018 at 17:00 BST.
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.
Why You?Basic qualifications:
- BSc or equivalent in Biotechnology, Biological Science or related discipline
- Experience in Quality Control for pharmaceuticals
- GMP and Quality Management understanding.
- Experience of Quality control for cell and gene therapy or Biopharm products
- Experience of regulatory interactions and regulatory documentation
- Demonstrable ability to interact successfully with external auditors
- Good technical understanding of analytical techniques required for the quality control of viral vector and cell products.
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
You may apply for this position online by selecting the Apply now button.
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