Are you energized by the challenge of shaping and developing analytical methods to accelerate getting medicines to patients faster? If so, this investigator role in Cell & Gene Therapy, analytical development CMC could be an exciting opportunity to consider!
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 currently has an opening for an investigator role in the Cell Analytics teaam, based at the GSK Upper Providence, Philadelphia, USA site 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 and 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.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- 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.
- 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).
- 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.
We are looking for professionals with these required skills to achieve our goals:
- Bachelors- or Masters degree in Cell Biology or Immunology
If you have the following characteristics, it would be a plus:
- PhD degree as preferred qualification with extensive experience in cell biology, immunology, or related scientific discipline.
- Experience working with 3rd parties and developing/maintaining working relationships with these partners.
- Experience in preparing oral and technical reports to influence strategic decisions.
- Industrial experience in cell culture and multi-colour flow cytometry panel design (minimum 5 years experience).
- Experience in the development of cell-based methods for producing and analysing primary, mammalian cell lines and T-cells and the characterization of these cells by flow cytometry.
- 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.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.
*LI-GSK #LI-GSK #CMCDevelopmentGSK
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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