Job summary
We are currently looking for a (adjective)Higher Scientist-Gene Therapyto join our (adjective)Research & DevelopmentTeam within theScientific Research & Innovationgroup.
This is afull-timeopportunity, on a14-month fixed term contract/internal move or temporary promotionbasis. The role will be based in South Mimms, Hertfordshire.Please be aware that this role can only be worked in the UK and not overseas. We are currently implementing a flexible, hybrid way of working, with a minimum of 4 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 8 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.
Main duties of the job
Oursuccessful candidatewill:
- PhD in a gene therapy or molecular biology related discipline with relevant practical experience (or equivalent industry-based experience) and understanding of the gene therapy field.
- Extensive practical experience in gene therapy, virology and/or immunology, including demonstrated cell biology experience in vector production, handling and manipulation of mammalian cell lines, primary T-cell isolation, culture, and transduction and multiparameter flow cytometry. Experience in molecular biology techniques such as q-PCR, ELISA and cloning.
- Experience in analysing information, including complex scientific data, to inform decisions and direct projects.
- Ability to work independently, monitor individual work milestones, manage multiple tasks, and prioritise workload accordingly. Demonstrate ability to work cooperatively as part of a wider multidisciplinary team, establishing professional relationships and sharing information and resources.
TO BE CONSIDERED FOR THESE ROLES, PLEASE COMPLETE YOUR APPLICATION ON MHRA WEBSITE
http://lhrc1a.rfer.us/MHRAvnE18E
About us
Who are we?
The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.
The Scientific Research and Innovation Group delivers public health impact, world-leading research innovation, and a unique regulatory proposition for patients and users via an ambitious Science Strategy. It is divided into 6 sub-Groups, Innovation Accelerator, Clinical Investigations and Trials, Research and Development, Standards Lifecycle, Control Testing and Quality Assurance and Health & Safety.
Research and Development (R&D) delivers an internationally leading programme that supports development of, and access to, novel biological medicines, physical biological standards, diagnostics, vaccines, biotherapeutics and advanced therapy medicinal products.
Job description
Job responsibilities
Key responsibilities:
- Optimise and establish molecular, genetic, and immunochemical assays for the generation and validation of viral vector standards and for the quality and safety control of Car-T cell therapy products.
- Contribute to the strategic direction of the R&D undertaken in the team, with a focus on the development of novel WHO International standards and assays for viral vectors. Initiate and plan a programme of research activities, collaborating internally and externally with expert scientists, including collaborating with the standards lifecycle and control testing functions of the group to provide expert scientific advice and timely practical support.
- Gather, analyse and effectively present information to colleagues and collaborators. Including engagement with national and international stakeholders including WHO, the global Pharmacopoeias, manufacturers, regulatory organisations, and academia.
- Take responsibility where required for laboratory facilities, contributing to maintenance and other lab duties.
Job description
Job responsibilities
Key responsibilities:
- Optimise and establish molecular, genetic, and immunochemical assays for the generation and validation of viral vector standards and for the quality and safety control of Car-T cell therapy products.
- Contribute to the strategic direction of the R&D undertaken in the team, with a focus on the development of novel WHO International standards and assays for viral vectors. Initiate and plan a programme of research activities, collaborating internally and externally with expert scientists, including collaborating with the standards lifecycle and control testing functions of the group to provide expert scientific advice and timely practical support.
- Gather, analyse and effectively present information to colleagues and collaborators. Including engagement with national and international stakeholders including WHO, the global Pharmacopoeias, manufacturers, regulatory organisations, and academia.
- Take responsibility where required for laboratory facilities, contributing to maintenance and other lab duties.
Person Specification
Qualifications
Essential
- -PhD in a gene therapy or molecular biology related discipline with relevant practical experience.
- -Considerable post-doctoral experience and an excellent understanding of the gene therapy field and of the requirements of best practice in research methodologies.
Experience
Essential
- -Extensive practical experience in gene therapy, virology and/or immunology.
- -Extensive practical experience of molecular and cell biology techniques, including qPCR, digital PCR and flow cytometry
- -Experience on developing and applying innovative technical procedures for product potency and efficacy analysis.
- -Experience in analysing complex scientific data using specialist tools.
- -Experience or interest in standardisation and medicines control
Behaviours
Essential
- Delivering at Pace - Regularly monitor your own and teams work against milestones ensuring individual needs are considered when setting tasks. Act promptly to reassess workloads and priorities when there are conflicting demands to maintain performance.
- Working together - Encourage joined up teamwork within own team and across other groups. Establish professional relationships with a range of stakeholders. Collaborate with these to share information, resources and support.
- Managing a Quality Service - Successfully deliver high quality outcomes that meet the customers needs and gives value for money. Identify risks and resolve issues efficiently
Strengths
Essential
- Analytical - You seek and analyse information to inform decisions based on the best available evidence.
- Team Player - You work well as part of a team and strive to ensure the team pulls
Person Specification
Qualifications
Essential
- -PhD in a gene therapy or molecular biology related discipline with relevant practical experience.
- -Considerable post-doctoral experience and an excellent understanding of the gene therapy field and of the requirements of best practice in research methodologies.
Experience
Essential
- -Extensive practical experience in gene therapy, virology and/or immunology.
- -Extensive practical experience of molecular and cell biology techniques, including qPCR, digital PCR and flow cytometry
- -Experience on developing and applying innovative technical procedures for product potency and efficacy analysis.
- -Experience in analysing complex scientific data using specialist tools.
- -Experience or interest in standardisation and medicines control
Behaviours
Essential
- Delivering at Pace - Regularly monitor your own and teams work against milestones ensuring individual needs are considered when setting tasks. Act promptly to reassess workloads and priorities when there are conflicting demands to maintain performance.
- Working together - Encourage joined up teamwork within own team and across other groups. Establish professional relationships with a range of stakeholders. Collaborate with these to share information, resources and support.
- Managing a Quality Service - Successfully deliver high quality outcomes that meet the customers needs and gives value for money. Identify risks and resolve issues efficiently
Strengths
Essential
- Analytical - You seek and analyse information to inform decisions based on the best available evidence.
- Team Player - You work well as part of a team and strive to ensure the team pulls
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
