- Contribute to the hands-on development and validation of analytical assays for both internal and external programmes, in line with regulatory expectations.
- Work collaboratively with Programme Management, Quality, Supply Chain, Development, Manufacturing, and other departments, to meet deliverables and timelines
- Ensure the organisation can deliver on a highly complex analytical testing portfolio whilst maintaining a high throughput of customer and internal projects.
- Author documentation such as standard operating procedures, validation protocols, various reports, as well as AD material ordering and storage area control.
- Participate in client meetings and support with client project communication.
- Participate and support investigations for OOS/Deviations /Change controls relating to materials coordinating with production.
- Maintain the calibration, qualification and validation of analytical testing equipment.
- Bachelor's Degree in one of the following fields of study: Biology, Biotechnology, Biochemistry or similar.
- An aptitude for Critical thinking and problem solving.
- Experience in a GMP Regulated CDMO would be beneficial.
- Experience working within Analytical Development environment.
- Experience of reagent preparations and material handling.
- Knowledge of equipment and instrument calibration, qualification, and validation. (UPLC, mass spectrometry, UV Spectrometry, real-time PCR/Digital PCR, Plate readers, Sanger Sequencing).
- Experience with at least two of the listed techniques from ELISA, enzyme activity assays, qPCR/digital PCR, U/HPLC, mass spectrometry is essential.
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Sr Analytical Development Scientist - Hampton, United Kingdom - Touchlight
Description
Touchlight is focussed on" The Making of DNA".
Through the Covid pandemic, this quiet revolution has been propelled into the spotlight with the scale-up and proof of concept of RNA and DNA based vaccines. In addition, the stellar growth in viral and non-viral cell and gene therapy discovery and development has accelerated the need for a better quality, faster and more robust DNA manufacturing technology.
Our CDMO and technology is built on the conviction that DNA is fundamental to the future of medicine.
By moving away from today's restrictive biological approaches, we have made DNA manufacturing simple. Our unique dbDNATM (or "doggybone" DNA) vector is optimised for use in advanced genetic medicines, being safer and more efficacious than conventional plasmid DNA. The platform, based on enzymatic technology, enables DNA production at unprecedented scale, speed and purity.
We are leveraging our platform to enable the next generation of Genetic Medicines.
Our CDMO Focus is on:
· Nucleic Acid Medicines (mRNA & DNA)
· ex-vivo & in-vivo cell and genetic medicines
· Gene therapy using viral vectors and gene editing
· Autologous & Allogenic cell therapy
Touchlight DNA Services is recruiting for an exciting role with a broad remit to support the business in maximising the potential of recent significant investment, sales growth, and a burgeoning DNA industry.
(Sr) Analytical Development Scientist (FTC 6 months)
You will be a critical member of the team driving Touchlight's analytical development success, focussing on supporting projects from all the relevant markets.
You will work with some of the biggest healthcare companies in the world to help support the production of dbDNA as a critical starting material for ATMP production and as an Active Pharmaceutical Ingredient.
Touchlight is currently seeking an experienced scientist to join its Analytical Development department. This role, based at the Hampton site (UK), would be suitable for someone with a passion for development of analytical tools for solving a wide range of client specific testing requirements. The role requires a high level of communication, planning and organisation, very dynamic, and ability to thrive in a fast-paced environment, dealing with multiple stakeholders, and managing evolving priorities.
The Sr Analytical Development Scientist is primarily responsible for supporting the team during all assay development activities including those required for a regulated environment, as well as participating in the sampling and testing using those analytical tools.
There will be a close interaction with the other operational departments to support on-going project and product needs.
The successful candidate will report directly to the Head of Analytical Development.
The principal responsibilities include:
Skills and Experience:
Touchlight Benefits
Touchlight is a successful scale-up business with a record of world-leading innovation and a welcoming, entrepreneurial culture. We make Touchlight an extraordinary place to work by providing our employees with incredible facilities, flexible working and a competitive benefits and remuneration package.
A Place for Everyone
We believe diversity drives innovation and for that reason we strongly encourage those from all backgrounds to apply for roles at Touchlight. We are an equal opportunity employer and aim to build a workforce that is truly representative of the communities in which we operate and our customers.
If you need reasonable adjustments at any point in the application or interview process, please speak with the HR team who will be happy to support you.
