job details for:
Pharmaceutical - Bioanalyst Jobs - London

Pharmaceutical - Bioanalyst Jobs - London (Job Ref: WR/JOBS/23628-9897)

Job Description :

Flame Pharma Pharmaceutical - Bioanalyst/Trainee Study Director Job – London:

Job Summary

The role of the Bioanalyst/Trainee Study Director will be to learn and understand how to conduct studies to GLP, OECD and FDA guidelines and to employ his/her laboratory skills to develop, validate and maintain analytical methods, especially using LC-MS/MS techniques and to make a contribution to the provision of an efficient laboratory service. This laboratory is a specialist analytical facility that provides for the measurement of many drugs and metabolites at nanogram concentrations in biological matrices. These samples originate from various sources such as epidemiological studies, GP’s, research projects and Pharmaceutical companies. The jobholder is expected to help the GLP compliance officer, QA Manager, other Study Directors and the Laboratory Head in the maintenance of an efficient GLP compliant laboratory and archives.

Job Title

Bioanalyst/Trainee Study Director

Background

Due to expansion, our client are recruiting a Bioanalyst/Trainee Study Director to be based in their offices in London.

Key Responsibilities

· To thoroughly understand the issues involved when developing, validating and applying generic quantitative LC-MS/MS assays including liquid-liquid and solid phase sample preparation.

· To understand the Study Director’s role in the whole process of method development, assay validation and analytical support from protocol to final report including category allocation and archive generation.

· To ensure that at each stage of the analysis, the jobholder makes checks to eradicate any possibility of self-induced error.

· To have a working knowledge of the mathematical and statistical calculations used in generating results. This includes accuracy and precision data derived from the QC’s run during the analysis.

· To maintain an efficient data archive according to protocol number and category for any of the data generated by the jobholder.

· The jobholder has the responsibility to ensure that all work conducted by her conforms to Good Laboratory Practice (GLP) and to our biological and chemical safety regulations (COSHH).

· To perform other extractions and procedures as required by superiors.

· To effectively communicate with superiors.

· To be experienced with the operation and routine maintenance of automated LC-MS/MS systems including 96-well plate technology for quantitative assays. In particular the operation of Applied Biosystems API 4000 tandem mass spectrometers using Analyst software, Agilent and Jasco HPLC systems and CTC autosamplers.

· To have sufficient HPLC knowledge to change and modify HPLC methods including UPLC.

· To know how to use automated sample processing devices such as TomTec.

· To understand how to use computers and calculators, their associated software and hardware to process and report analytical results and to understand the importance of audit trails, security and validation.

· To maintain good communication with other personnel within ABS and the Medical Toxicology Unit.

· To operate independently in terms of day-to-day work scheduling but to seek guidance when scientific and technical decisions are required.

· To be continually aware of the time taken to perform all laboratory tasks so as to maintain the desired output of work in terms of quality and efficiency.

Qualifications and Experience

· Relevant BSc degree or Phd

· Direct LC-MS experience

· Direct Bio-analyst experience

· Sufficient HPLC knowledge to change and modify HPLC methods including UPLC

Benefits

With this position comes an attractive benefits package that you associate with a world leader, including pension, healthcare, plus a salary circa £30,000.

Key Words 

Bioanalyst/Trainee Study Director, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research.

This role is to be based in London.

For further information about this role, please contact Flame Pharma.