MHRA: Scientist (Biotheraputics) - South Mimms

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY

Job Description and Person Specification

JOB TITLE: Scientist (Biotheraputics)    
PAY BAND AND SALARY: HEO £29,992 - £31,582
LOCATION:    South Mimms
HOURS:    36 per week (excluding lunch break)
CONTRACT TYPE:     Fixed term contract for 2 years
ACCOUNTABLE TO:     Helen Wilmot

The National Institute for Biological Standards and Control (NIBSC), world leaders in assuring the quality of biological medicines through product testing, developing standards and reference materials and carrying out applied research is now a new centre of the Medicines and Healthcare Products Regulatory Agency alongside the Clinical Practice Research Datalink (CPRD).

Purpose of the role:   
The Haemostasis Section of the Biotherapeutics Group is heavily involved in the two core activities of NIBSC, the Official Control Authority Batch Release (OCABR) of blood-derived therapeutics and the preparation of International Standards on behalf of the World Health Organisation (WHO).  The Section also undertakes active research and development in related areas and provides support for regulatory authorities in the investigation of adverse events and the provision of expert advice.  This role, reporting to a Senior Scientist within the Section, will assist in contract manufacture of standards, preparation of International and other standards, and batch release testing of factor IX therapeutics.  The successful candidate will also be expected to carry out research and development relating to the laboratory’s research programme, including factor IX therapeutics and pro-coagulant activity of IntraVenous ImmunoGlobulins.

Key responsibilities:
To provide scientific and technical expertise.  In this post the job-holder is expected to carry out the core scientific activities of the Institute which include:
• Control of blood products and related therapeutics.  This involves Official Control Authority Batch Release (OCABR) of these products under the UKAS accredited quality system (ISO/IEC 17025)
• Preparation of International and national standards and other relevant  reference materials according to WHO guidelines and NIBSC quality system for preparation of reference materials
• Carry out contract testing (some of which are under ISO 17025 standards) and support contract manufacture of reference standards, for developmental and licensed therapeutics
• Carry out research and development work on a number of different projects within the laboratory’s research programme, which underpin the control and standardisation core functions
• Contribute to the day to day running of the laboratory
• Contribute to formal training of all grades of scientists (as appropriate) and visiting workers in accordance with
NIBSC guidelines.


Qualifications required
• Upper second class BSc (Hons) degree or equivalent in a relevant biological science with significant experience working in a laboratory.

Competencies:
1.Significant experience of working within a laboratory, preferably with a scientific and technical background in haemostasis.  
2. Proven ability to develop and manage own scientific research projects.
3. Able to learn new methods and adapt methods as required and to carry out assays with high precision and accuracy.
4. Experience of working within a quality system would be beneficial (ISO 17025).
5. Able to work independently and as part of a team and shows excellent organisational and time management skills.
6. Excellent written and verbal communication skills for preparation of technical reports and presentations with the ability to analyse complex information.

MHRA values
• Innovative
• Proactive
• Impartial
• Evidence-based
• Open
• Trustworthy

How to apply:
Please ensure to review the full job description and competencies in relation to this position prior to applying. Applicants will be expected to meet and address all the competencies in order to be shortlisted for the interview stage. You can apply for this position by creating a job profile on the Civil Service Jobs Portal here: https://jobsstatic.civilservice.gov.uk/csjobs.html

We are an equal opportunities employer and welcome applications from suitably qualified people regardless of age, gender, sexual orientation, marital status, race, religion, politics or disability.

All civil servants work within the boundaries of the Civil Service Code. The Code sets out the duties and responsibilities of all civil servants.
Please click on the 'Apply now Button' below for more information:

The closing date for applications is 20 October  2013

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