Analytical Development Scientist, Molecular Biology

Basic qualifications:
• BSc in biology, cell biology, virology, biochemistry or related scientific discipline.
• Experience in analytical method development/validation for vaccines, biopharmaceutical or cell and gene therapy products.
• Strong organisational 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 biology, cell biology, virology, biochemistry or related scientific discipline.
• Experience in analytical development in support of recombinant viral vector production and T-cell therapies.
• Experience in the development of molecular biological methods (e.g. qPCR, ddPCR) to characterise viruses and cells.
• 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 is critical.
• 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.

Details:
GlaxoSmithKline (GSK) is one of the world's leading research-based pharmaceutical companies. Our powerful combination of skills and resources provide the platform for delivering strong growth and the platform for responding quickly to the rapidly changing global healthcare environment. We are a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. We have a significant global presence with commercial operations in more than 150 markets, a network of 86 manufacturing sites in 36 countries and large R&D centres in the UK, USA, Spain, Belgium and China.

In recent years, GSK has been working with a leading academic group in Italy to develop ex vivo gene therapies for Rare Diseases. We now have three late phase products. More recently, this approach has started to show similar transformational potential in the oncology field, and GSK has secured a significant collaboration in this area. 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 Rare Diseases 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 Cell and Gene Therapy Platform. As a member of this cross functional team the successful candidate will have responsibilities in regards to analytical development

We are currently recruiting an Analytical Development Scientist, Molecular Biology to be based in Stevenage, Hertfordshire, UK. This role will see you owning and managing analytical methods lifecycle during clinical development whilst working with colleagues in validation and QC for post approval analytical life cycle management and alignment with continued process verification plans.

The successful candidate will be involved with a diverse range of activities including:

• Development of analytical method and transfer to internal QC and Process Development laboratories, and CMOs or testing laboratories.
• Support establishing internal laboratories for analytical development for T-cell 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.
• 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).

Closing date for applications: Tuesday 29th August 2017.

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 . 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.

*LI-GSK

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

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