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Scientist/Documentation Lead (Analytical Sciences) - AB78 - Allergan Biologics Ltd.

Posted: 2 August 2017

Closing: 25 August 2017

Reports to: Analytical Sciences Team Leader
Supervisory responsibility: None
Budgetary responsibility:  None
Location:  Liverpool, UK.

Key objectives and responsibilities include, but are not limited, to those below:

• Apply HPLC, Immunoassays, UV, SDS-PAGE and Western Blot methods to development and QC test samples.
• Perform routine utility testing including TOC, Conductivity and Nitrate tests to GMP standards.
• Interpret and analyse experimental results and communicate them effectively with guidance from a Senior Scientist.
• Communicate effectively with other team members and with other groups within the organisation to ensure data is transferred successfully.
• Perform raw material sampling and interpret results.
• Assist in the validation of analytical methods by writing and executing of analytical method validation protocols and associated reports.
• Perform equipment validation activities including the writing of equipment URS, System Impact Assessment, IQ/OQ/PQ protocols and reports,
• Maintain the SOP’s held with Analytical Sciences by placing newly issued documents in the designated document copy holders and to withdraw any obsolete or superceded documents from the document copy holders as requested by the Quality Assurance department.
• Maintain the Analytical training matrix and update when new versions of procedures are available.
• Input data into excel spread sheets for trending of utility, stability and assay control test data.
• Perform housekeeping activities including but not limited to, checking of laboratory logbooks, status labelling equipment, test record issue and reconciliation.
• Assist in the filing and archiving of all completed documents.

General Responsibilities:

• To comply with the requirements to work in accordance with cGMP.
• To write up all experiments performed into test records laboratory books, in a timely fashion.
• To generate and review, SOPs, work instructions/ records and study reports and associated generated data.
• To instigate the necessary investigations and documentation for Out of Specification results and Deviations.
• To request test records as required by the team and ensure timely reconciliation.
• To report figures for outstanding QMS (i.e deviations/CAPA’s) and training compliance to Analytical Sciences manager.
• To train colleagues in analytical methods, as required.
• To be involved in the daily housekeeping of the laboratory areas and shared support areas.
• Maintain stock levels of consumables and reagents by ordering reagents in a timely manner.
• To comply with the requirements of the Health and Safety Policy by performing COSHH and equipment risk assessments and ensure MSDS are present and up to date before ordering reagents.
• Be aware of risk assessments specific to equipment, laboratory, products and reagents.
• To work shifts when required to support in-process analysis.
• Any other duties that are required to fulfil the job purpose.

Qualifications, Skills and Experience:

• Bachelor of Science and experience working within a Quality Control laboratory environment, preferably within the biopharmaceutical/Biotechnology Industry.
It is essential the successful candidates will possess:
• Experience of current Good Manufacturing Practice (cGMP).
• Analysis of in-process/final product samples under development and QC conditions
• Working knowledge of the European Pharmacopoeia.
• Microsoft Word and Microsoft Excel skills.
• Good organisational skills
• Working knowledge of analytical techniques including but not limited to:
- SDS-PAGE and Western blot
- UV

How to Apply:

If you are interested in applying for this position, please send an email quoting the appropriate reference number in the subject field along with a covering letter and your CV to

Closing date for applications is 5.00pm on Friday 25th August 2017.