Quality Control Scientists/ Analysts – Cell and Gene Therapy
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 Cell and Gene therapy 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. 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
We have multiple opportunities at different levels for highly motivated and independent cell scientists/Analysts with Quality mindset.
- Quality control of gene therapy products within GSK or at third parties.
- Lead, Support and perform Tech transfer, validation and routine analytical techniques used for the testing and release of cell and gene therapy products, including flow cytometry, qPCR, ddPCR, ELISA etc.
- 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.
- Ensure data integrity is maintained for all work performed.
- 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.
- Provide data and/or writing section for regulatory submissions
BSc or equivalent in Biotechnology, Biological Science or related discipline.
Experience in Quality Control for pharmaceuticals.
GMP and Quality management understanding.
Strong organisational and communication skills.
Demonstrable ability to work in multi-disciplinary, multi-cultural teams.
Demonstrable ability to work independently, to plan and carry out the tasks required to manage responsibilities and complete objectives.
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. Ability to interact successfully with external auditors.
The positions will be based at GSK’s state-of the-art Medicines Research Centre in Stevenage within Cell and Gene Therapy GMP operations. European and international travel will be required at times, as dictated by the project needs.
When applying for this role, please use the 'cover letter' of the on-line application of our website below 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.