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Bioassay Scientist, Analytical Sciences - Allergan Biologics Ltd.

Posted: 10 July 2018

Closing: 27 July 2018

This position is for a bioassay scientist based in the Cell & Molecular Biology team within Analytical Sciences.

Utilising your previous experience with bioassays, your role will focus on the development and application of cell based potency assays to support several biologic products including AAV gene therapy vectors and monoclonal antibodies. Previous experience of other types of cell based work (e.g. TCID50), molecular biology techniques (e.g. qPCR) and label free binding technologies (e.g. SPR) would be advantageous but not essential.

1. General Description of Responsibilities:

The Scientist, Analytical Sciences reports into the Snr Manager of Analytical Sciences and has responsibility to perform Analytical Sciences activities within Allergan Biologics at Liverpool. The role holder is responsible for performing the analytics associated with the transfer, application, development, optimisation, phase appropriate validation of analytical methodologies for testing and cGMP release of products from early concept through to registration for marketing approval.

The Scientist, Analytical Sciences is responsible for performing assay development routine and cGMP testing for new product development programmes, which may encompass fully in-house programmes, in-licensed products and products in development with partners and ensures the testing is performed by the group on time, on budget and in compliance with the established quality standards. This includes release testing of non-clinical and clinical drug substance.

2. Leadership Responsibilities:

The Scientist, takes specific responsibilities for leading activities within the group, including:
Maintain exemplary standards within the laboratory.
Lead the development and delivery of routine analytics to support product development and cGMP production activities through all stages of bioprocessing (upstream and downstream) to meet project timelines.

To put forward and deliver ideas to overcome technical problems or introduce new efficiencies

Collaborate effectively across cross functional teams to deliver requirements of projects

Training in new analytical methods and training others in techniques/technologies.

Transfer of methods through to routine application either internally or to external partners.

Lead on the delivery of new capital equipment items to increase Analytical Sciences capabilities.

Executing method qualification and validation protocols and assist in writing the associated reports as required to support transfer of processes into the manufacturing facility, under the guidance of Snr Scientists.

Performing Analytical Sciences testing of facilities water points, raw materials, in process product release and stability and the lead the management of samples for projects assigned to them. They are responsible for interpreting and analysing experimental results and communicating them effectively via study reports and presentations to Snr Manager, Analytical Sciences

Writing procedures to the required quality for Global Research and development and cGMP compliance for all areas of Analytical Sciences and ensure traceability and documentation of the development and validation of the procedures.

Performing trend analysis of routine testing and ensuring test specifications are met for raw materials, water testing and intermediate/final products and reporting out of specifications to Snr Manager, Analytical Sciences.

Initiation and investigation of OOS’s, Deviations, Change Controls and CAPAs and notifying Snr Manager, Analytical Sciences of the occurrence.

3. Operational Responsibilities:

Responsible for supporting the Snr Scientists, Analytical Sciences to ensure current project timelines by;
• Ensure all documents are completed and approved before execution of tasks or experiments
• Complete all laboratory documentation in a timely and compliant manner, participating in reviews of the documentation to obtain quality sign off when necessary.
• Analyse any investigation data to a high standard and ensure that protocols and procedures are delivered with a high attention to detail
• Effectively communicating with analytical technical lead to ensure data is transferred successfully.
• Writing technical reports for issue to the client or inclusion to support internal Regulatory Submissions.

Subject matter expert in areas relating to analytical method development, transfer, qualification and validation and stability testing.

Taking ownership of the installation and validation of analytical equipment by writing and executing equipment validation documentation including but not limited to URS, trace matrix, IOQ, SOP’s, protocols and reports in line with quality procedures and guidelines.

Performing housekeeping within the Analytical Sciences Laboratories, ensuring safety standards are maintained.

Ensuring equipment logbooks are kept up to date and filled in using the appropriate guidelines.

Providing training to colleagues in analytical methods, as required.

Maintaining stock levels of consumables and reagents by ordering reagents in a timely manner and ensuring COSHH assessments/MSDS are present and up to date before ordering reagents.

Proactive in personal development and maintain an up-to-date, accurate training record to meet all required operating procedures for activities and including ensuring all heath safety and environment training is complete.

Contribute to 5S as a means for continuous improvement to ensure that department goals are achieved and the incidence of non-conformances are reduced

Undertake other responsibilities as required depending upon work demands and support working shifts.

4. Experience and Qualifications:

• Minimum qualification of BSc in relevant biological sciences related subject.
• Experienced in the analysis of biomolecules.
• Experience of current Good Manufacturing Practice (cGMP).
• Working knowledge of the following techniques:
Cell culture and cell based assays (e.g. Potency, TCID50, Flow Cytometry)

• Ideally, working knowledge of techniques including but not limited to:
Molecular biology (e.g. PCR, qPCR, Sanger Sequencing)
Immunoassays (e.g. ELISA, Western Blotting)
Label free binding (e.g. SPR, BLI)

• Experience in writing procedures, protocol and reports.
• Clear understanding of the science and a passion for keeping abreast and implementing analytical advancements.

5. Personal Attributes

• Good analytical skills with the ability to analyse, interpret results and solve complex problems.
• Strong organisational skills with the ability to manage/prioritise workloads for various project types to meet project timelines.
• High level of IT proficiency.
• Demonstrable communication and interpersonal skills to report and communicate experimental findings effectively.
• High attention to detail, adaptable, personable and technically competent.
• Ability to work effectively within a dynamic team.
• Aptitude for identifying and implementing new technologies.

Job Reference Number: 181251
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