Senior Scientist – Molecular Biology – Assay Development Team

Organization: 
QuantuMDx
Job Location: 
Newcastle Upon Tyne, UK
Job Description: 

QuantuMDx is committed to recruiting an outstanding Senior Scientist during a critical period of the Company’s growth and evolution. The Senior Scientist will report directly to the Laboratory Manager and will work within an interdisciplinary team developing molecular diagnostic assays for infectious diseases and genetic tests.

A key success factor for this position is the ability to work in a fast paced, cross functional group environment, with a willingness to be hands-on across a wide area of responsibilities.

This ideal candidate is someone with diverse experience and great capacity and desire for taking on new responsibilities and challenges as the company grows.

This position is responsible for developing clinical & scientific research for in-vitro diagnostic (IVD) products in the area of nucleic acid testing. The initial focus of the work will be to develop multiplex PCR assays for a variety of diseases and translating these assays from the bench to QuantuMDx’s hand -held platform.

•The candidate hired for this role will work within a team of scientists developing molecular diagnostics assays for a range of diseases and translating these assays to QuantuMDx’s portable molecular diagnostic device.
•The candidate will also be required to not only work within the assay development team based in Newcastle-upon-Tyne, but also work as part of a wider research group globally, with QuantuMDx’s other labs and partners labs.
•To interact with, and ensure excellent communication with, the other QuantuMDx R&D groups primarily sample preparation and biosensing teams.
•To generate data based hypotheses, design day-to-day experiments, generate longer-term worplans and be pro-active in providing solutions to problems as they arise
•Adhere to all of QuantuMDx’s Quality Assurance (QA) Systems.
•Working with senior management, ensure the Company’s research is fully compliant with Quality System Regulations (QSRs) that meet FDA, IVDD, and ISO expectations.
•Write and review grant application, patents and peer reviewed journal articles when required.

Requirements: 

•The candidate hired for this role will be an extraordinary individual who has strong technical understanding and experience in molecular diagnostic assay development and a proven ability to work within a team of scientists and engineers to accomplish product development goals.
•Experience with IVD assay development is required and experience of developing Medical Devices is desirable.
•The successful candidate will have in-depth knowledge of PCR, RT-PCR, microarray design and a strong background in Bioinformatics and statistical analysis.
•A firm understanding of the molecular diagnostic market and a working knowledge of different biosensor strategies is desirable.
•In depth knowledge of microfluidic based assays is essential for this position.
•Knowledge of nanotechnology and an understanding of basic electronics are also desirable.
•Experience with working with QSR requirements (21CFR820).
•Familiarity with global regulatory requirements that pertain to product development and IVD manufacturing (e.g. CE IVD mark, FDA, etc).
•Excellent communication skills and ability to work in a changing environment on complex projects. Outstanding teamwork and an ability to interact with external and internal partners on fast-paced projects.
•Minimum 5 yrs experience working in an In Vitro Diagnostics company and has designed and/or manufactured an IVD or medical device using QSRs.
•PhD in Molecular Biology or Biochemistry preferred or Life Sciences acceptable.
•Good sense of humour, team player and an ability to adapt to a rapidly changing environment as the Company matures and moves from the R&D stage into commercialisation is essential.
•The ability to work full time without restriction in the UK.

Contact Information: 

Interested Candidates should send their CV and covering letter to maria.kelly@quantumdx.com

About Our Organization: 

QuantuMDx Group is a vibrant medical devices company developing hand‐held and portable low cost molecular diagnostic, DNA sequencing & proteomic platforms capable of supporting the delivery of personalised medicine across both developed and developing nations.

Our initial focus is to develop and commercialise simple, easy to use MDx devices that not only deliver rapid & accurate - sample to result - medical diagnosis for complex diseases within minutes at the patient’s side, but can integrate with mobile apps for ongoing support and education of patients.

Our first commercial product, due out in 2014, will be the Q-POC™, QuantuMDx’s hand-held point of care platform, with first commercial assays in companion diagnostics and multi-drug resistant infectious disease testing (including TB, malaria and STIs). Products in development include Q-SEQ™, a 5th generation DNA sequencer, and InVenio™, a biomarker discovery engine capable of undertaking a whole proteome analysis which will eventually be integrated into Q-POC™