Vector Formulation Senior Scientist, Open to flexible working
GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
In recent years GSK has been working with a leading academic group in Italy (TIGET) to develop ex vivo gene therapies for Rare Diseases. We have three ex vivo gene therapy products in late stage development. More recently GSK has secured 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-end leading 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 in other therapeutic areas.
Cell and Gene Therapy Platform CMC team is a cross functional team covering vectorology, process development, analytical development, QC, supply chain operations/strategy. The team has aligned support from Quality, Regulatory and other functions. The team works in close partnership with cell and gene therapy discovery research capability (focussed on translation medicine, target biology/payload) and the therapy areas to provide the end-end capabilities required for the therapy areas.
The team will grow rapidly to enable delivery of a multiproduct pipeline and building a world-class capability in CMC/supply to ensure GSK's positioning as a leader in the gene therapy field. A critical part of this growth will be the formation of a specific formulation/delivery capability to support the cell and gene therapy platform. This role will be based in the UK at the Stevenage site.
Key Responsibilities include, but are not limited to:
- Work within the team to develop formulations across multiple programs, primarily for Lenti-virus and AAV, also contributing to developing cell formulations.
- Develop stability strategies, fill finish capabilities and packages for the portfolio.
- Work closely with vector and cell process development scientists to ensure formulations developed can be applied to the planned processes.
- Provide analytical testing support to ongoing formulation and development stability studies.
- Reports to Team Leader, Formulation Dev, Cell & Gene Therapy Platform CMC.
- Partner with colleagues and line management to set up internal laboratory for formulation development of cell and gene therapy products.
- Deliver novel formulations (though internal work, partnering, licensing) and associated technologies to enable step change performance in product stability and deliverability for viral and cell products
- Collaborate with colleagues in GMP Operations and supply chain to support development of supply chain strategies, production and packaging solutions
- Collaborate with external partners to design and influence experimental work at partners for formulation development
- Participate in MPD sub teams on drug product development
- Through participation at external meetings and published literature keep current with emerging technologies to bring best science to bear on formulation development
- Author regulatory documents and provide subject matter expert support for regulatory interactions.
Key Leadership Expectations:
- Willing to learn: adapt to change quickly.
- Drive performance: Holding yourself, your team and others accountable for delivering quality results.
- Work across the boundaries: Work collaboratively with other line members within C> team and active communication with clinical development and other lines within PTS.
Closing Date for Applications: Wednesday 16th June 2021 (COB)
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.
We are looking for professionals with these required skills to achieve our goals:
- MS and relevant experience in biology, biochemistry, gene/cell therapy, biopharmaceuticals, vaccines.
- Experience of working with Lenti-virus/AAV.
- Experience with biopharmaceutical development and relevant documentation writing.
- Understanding of clinical administration procedures, techniques and risks/challenges relevant to biological or cell products.
- Ability to plan and drive experiments internally and with external partners.
- Fast learner with track record of working with new technologies.
- Good communication and presentation skills.
If you have the following characteristics, it would be a plus:
- Postgraduate education (PhD) within relevant field of study.
- Experience in formulation development of either: biopharms, vaccines, vectors, cell products or novel small molecule platforms.
- Demonstrate innovative thinking.
- Hands-on experience with analytical techniques in studying viral vectors, cell based products, biopharms, or vaccines.
- Experience with regulatory submissions and supporting regulatory interactions.
- Understanding of cGMP guidelines.
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.
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