Analytical Development Senior Scientist
Site Name: USA - Pennsylvania - Upper Providence Posted Date: Jul 19 2021 GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to support our mission to improve the quality of human life by enabling people to do more, feel better and live longer. GSK's Cell & Gene Therapy Platform CMC team is being expanded to support an increasing portfolio of cell and gene therapies. The team is responsible for delivering the Chemistry, Manufacturing and Controls (CMC) aspects of the projects from early phase to launch, as well as the development of innovative technologies to enable step-change improvements to cell & gene therapy manufacture. 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 facilitate 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. A key CMC challenge in this endeavour 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. Key Responsibilities Development of analytical methods and method transfer to internal Product Development, QC laboratories, and CMOs or testing laboratories Support establishing internal laboratories for analytical testing for 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 Participate in risk assessments to develop robust product control strategies for cell & gene therapy programmes Maintenance of laboratory equipment and critical reagents including analytical method control preparation and maintenance Own and manage the analytical method lifecycle during product development, including risk assessments and preparation of qualification reports Support capability build in other functional areas as needed Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter' of the online application or your CV 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. 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. *LI-GSK Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: BSc/MSc degree (or equivalent) in a relevant life science discipline Industrial experience in execution of analytical procedures to enable the release and/or Characterize biopharmaceutical or cell and gene therapy products Experience in the development, optimization, and troubleshooting of protein analytical methods Strong organisational and excellent interpersonal communication skills Ability to work independently, proactively seeking solutions for problem solving, within a matrix team environment Familiarity with basic statistics and troubleshooting of out of specification/trend results Preferred Qualifications If you have the following characteristics, it would be a plus: Experience working with 3rd parties and developing/maintaining working relationships with these partners Experience in preparing oral and technical reports to influence strategic decisions Experience in analytical development in support of recombinant viral vector production and T-cell therapies Experience in the development of cell-based and molecular biological analytical methods to characterise viruses and cells such as flow cytometry, clonogenic potential assays, imaging, qPCR and ddPCR Experience of vaccines, biopharmaceutical or cell and gene therapy product development Knowledge of QbD approaches to analytical method development including risk assessment, DOE and statistical analysis Experience of 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 Experience in analytical method transfers, qualification and control strategy development Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. 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