GxP Lab Analyst

Reporting directly to the Analytical Manager this is an exciting new opportunity to join the PsiOxus GxP (Good Manufacturing/Clinical/Laboratory Practice) laboratories, to perform analysis of test material to support batch release, stability assessments, toxicology studies and samples from clinical trials, that adheres to relevant GxP quality standards.

Overall responsibilities will include, but are not limited to:

=   Routinely perform and document a range of cell based, molecular, biochemical, physicochemical, immunochemical (and other methods) assays, as required, for example:

=         Samples obtained during clinical trials

=         Batch release

=         Manufacturing samples generated at CMO

=         Stability samples.

=   Generate analytical data, in accordance with GxP principles and PsiOxus policies and requirements. 

=   Liaise with the analytical development group to support assay transfer, qualification, development, validation and routine analysis to support PsiOxus projects.

=   Assist with the writing of technical review technical procedures, SOPs, protocols and reports, ensuring good quality guidelines are adhered to throughout.

=   Assist with investigations, audits and internal inspections. 

=   Operate and maintain the office/laboratory facility and the systems within, to both PsiOxus and GxP quality standards. For example:

=         Routine calibration and maintenance of equipment.

=         Timely completion of logbooks.

=         Ensuring equipment is correctly calibrated for use.

       =         Tracking and trending of data.

=         Timely completion of control charts.

=         Trending analysis of control chart data as per PsiOxus procedures.

=   Carry out sample receipt, storage, tracking and disposal to appropriate quality standards.

=   Provide technical guidance and training to other members of the department as required.

=   Maintain an up-to-date GxP training record.

=   Report all data, results, issues and potential delays to Line Managers.

=  Operate to PsiOxus lab/office safety and other standards, following PsiOxus policies, regulatory and quality guidelines.

=   Report all data, results, issues and potential delays to Line Manager.

=   Travel, as may be reasonable, to meet project needs.

=   Any other tasks, as delegated, to support the needs of the organisation.

The successful applicant will have had some practical laboratory experience in a biotechnology/pharmaceutical setting and will have the following attributes:

=    BSc or higher qualification in a life science discipline.

=    Good knowledge of GMP, GCP, GLP, ICH and other analytical regulatory guidelines would be advantageous.

=   Proven ability to work and communicate effectively as part of a team and liaise with teams in other organisations.

=   Excellent attention to detail.

=   Good organisational skills.

=   Applicants must be self-motivated, work to tight deadlines and be capable of readily adapting to changing priorities in a fast-paced environment.

The closing date for applications is 12th August 2018, however applications will be evaluated in the order that they are received. You are therefore encouraged to apply as soon as possible.  

**Previous applicants need not apply**