Analytical Development Scientist

Basic qualifications: 

BS or equivalent in biology, cell biology, virology, biochemistry or related scientific discipline
Experience in analytical method development/validation or QC for vaccines, biopharmaceutical or cell and gene therapy products
Demonstrated experience in analytical method transfers and control strategy development for biopharm/vaccine processes
Experience working with Adeno-associated viral vector
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: 

BS or equivalent in biology, cell biology, virology, biochemistry or related scientific discipline
Experience in analytical method development/validation or QC for vaccines, biopharmaceutical or cell and gene therapy products
Demonstrated experience in analytical method transfers and control strategy development for biopharm/vaccine processes
Experience working with Adeno-associated viral vector
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

Details: 

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 
Specific responsibilities for the position include the following:
• Development of analytical method and transfer to internal QC and Process Development laboratories, and CMOs or testing laboratories
• Support establishing internal laboraties for analytical development for AAV based products
• Own and manage analytical methods lifecycle during clinical development. Work with colleagues in validation and QC for post approval analytical life cyle management and alignment with continued process verification plans 
• Contribute to product specification development
• Partcipate 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). 

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.

If requiring an adjustment for a disability, once selected for interview you may contact ukdiversity.recruitment@gsk.com

Closing Date: 27th October 2016

*LI-GSK

Contact information: 

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