Analytical Development Scientist - CGT Vector Analytics

Job description

Details:
GSK has been working with a leading academic group in Italy to develop ex vivo gene therapies for ultra-rare diseases. Having delivered on Strimvelis for the treatment of ADA-SCID, and having made significant advances with WAS and MLD, we are applying these learnings to more common disorders such as beta thalassemia and cancer. In addition, GSK has also secured a significant collaboration in the oncology area to develop transformational medicines.

The progression of our own portfolio together with the promise of newer gene therapy technologies creates an imperative for GSK to build an industry leading gene therapy platform. This will enable delivery of the portfolio in blood disorders and oncology as well as ensuring that GSK is able to capture the potential of the emerging technologies.

The CMC capabilities for this platform are being built within the Platform Technologies and Sciences group. A key 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 methods and transfer to internal Product Development and QC laboratories, and CMOs or testing laboratories
• Support establishing internal laboratories for analytical development for stem cell and T-cell therapy products
• 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
• Contribute to product specification development
• Participate in risk assessments to develop robust product control strategies for cell/gene therapy programs
• Responsible for management and successful closure of investigations
• Leading an analytical work stream to set analytical strategy for CGT products
• Own and manage the analytical method lifecycle during product development, including risk assessments and preparation of qualification reports.
• Support colleagues in QC and Validation and Life Cycle Management for post approval analytical life cycle management
• Responsible for delivery of relevant sections of regulatory filings and responses to regulatory questions
• Support capability build in other functional areas as needed
• Responsible for successful interactions with contract manufacturing at third party manufacturers and testing laboratories. The role requires significant external engagement with 3rd parties (contractors, suppliers, testing laboratories, academic and industry groups).

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 to describe how you meet the competencies required for this role, as outlined in the job requirements above. Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.

Closing date: 7th September 2017

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

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jobDetails

Desired profile

Basic qualifications:
BSc in biochemistry, molecular biology, cell biology, virology, or related scientific discipline
Experience in analytical method development
Strong organizational and excellent interpersonal communication skills
Demonstrated excellence in technical writing skills
Demonstrable ability to work in multi-disciplinary, multi-cultural teams
Demonstrable ability to work independently, influence others and lead a project or team

Preferred qualifications:
Advanced degree in biochemistry, molecular biology, cell biology, virology, or related scientific discipline
Experience in CMC analytical development in support of recombinant viral vector production, stem cell and T-cell therapies, including transduction of cell lines with viral vectors
Experience of vaccine, biopharmaceutical or cell and gene therapy product development
Expertise in the development of physicochemical methods such as gel electrophoresis, RP-HPLC, SEC, and IEX for the analysis of viruses and macromolecules
Experience with nucleic acid sequencing and viral vector particle analysis/quantification, SEC-MALS, DLS, NTA, and related particle assessment techniques
Knowledge of QbD approaches to analytical method development including risk assessment, DOE and statistical analysis
Experience with establishment and oversight of development and testing at an external organization
Experience working with 3rd parties and developing/maintaining working relationships with these partners
Experience leading 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
Demonstrated experience in analytical method transfers and control strategy development