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Senior Scientist, Analytical Sciences (Analytical Applications)

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Research & Development
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185025 Requisition #
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The Senior Scientist, Analytical Sciences reports into the Senior 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 of a variety of Biological products including Gene therapy products.

The role holder also has responsibility for representing the organisation at conferences, presentations, external training and client visits to ensure our visibility in the Biopharmaceutical Industry and Academia and establishing our credibility through attendance and/or delivery of presentations. Also to develop an understanding of new technologies used and apply initiative to optimise the current methodologies used.

The Snr 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 clinical drug substance.

The Snr Scientist, Analytical Sciences is responsible for supporting/leading optimisation/qualification and/or technical transfer of validated methods and the validation of developed assays for cGMP testing by acting as a technical lead.

The Snr Scientist, Analytical Sciences is responsible for supporting the management of stability studies with respect to time point pulls, writing/reviewing stability protocols/reports, shelf life extensions and data trend analysis.

The Snr Scientist, Analytical Sciences is responsible for compiling analytical data and writing technical reports as part of the ongoing product development activity to support Regulatory Filings. In addition, provide technical expertise to assist in trouble shooting issues during technical transfer or routine production.

The Snr Scientist, Analytical Sciences is required to perform all assigned activities in accordance with regulatory requirements and HSE Policies and Procedures.

 

Leadership Responsibilities

 

As Technical Lead or acting Technical Lead report to Project/ Program Managers in the organisation any required project work and attend internal/ client project meetings, when required.

Prepare resource plans showing requirements to deliver programme of work and negotiate availability with stakeholders. Effectively communicate updates to stakeholders in a timely manner.

Prepare daily activity plans to deliver projects and communicate to other senior scientists and scientists working on the project as well as other contributing departments, such as Process Sciences, Engineering and QA

Organise project activities and routine analytics within the laboratory ensuring issues are flagged, solutions proposed and decisions made and acted upon

Accountability for the delivery of continuous improvement projects within the group to drive the introduction of new efficiencies or implement technologies that demonstrate positive impact upon compliance and the business

Manage lab areas, including supervision of scientists, resolve day to day equipment or technical issues and escalate issues when necessary to Snr Managers.

Provide coaching and guidance to others


Technical transfer of analytics from:

• External partner companies to Allergan Biologics
• Internally within Allergan Biologics, i.e. between laboratories
• Allergan Biologics to other Allergan sites and external partners

Responsible for managing and co-ordinating projects assigned to you as the Technical Lead to ensure current project timelines by;

• Collaborating with technical leads to deliver the project activities by ratifying analytical sample submissions and designs of experiments.

• To develop an understanding of the techniques used and apply initiative to optimise the methodologies used.

• Write up all experiments performed into test records/ proforma’s, workbooks or laboratory books in a timely and compliant manner.

• Effectively communicating with other team members and with other groups within the organisation to ensure data is transferred successfully.

• Write challenging protocols and proposals to address complex or multi-faceted investigations. Write development operating procedures and reports with minimal corrections on review.

• Writing and reviewing technical reports for issue to the client or inclusion to support internal Regulatory Submissions.

Responsible for acting as a technical lead on projects/methods assigned to them including the development, optimisation and transfer of methods through to routine application either internally or to external partners.

Responsible for leading installation and validation of analytical equipment by writing and reviewing equipment validation documentation including but not limited to URS, trace matrix, IOQ, SOP’s, protocols and reports in line with quality procedures and guidelines.

Responsible for development, transfer, qualification and validation of methods required to support processes into the manufacturing facility.

Responsible for the generation and review of raw material and drug substance specifications.

Responsible for managing the initiation, investigation and closure of OOS’s, Deviations, Change Controls and CAPAs.

Responsible for supervising and prioritising the day to day activities of the Scientists in Analytical Sciences. 


Operational Responsibilities:

Responsible for performing analytics to support product development and cGMP production activities through all stages of bioprocessing (upstream and downstream).

Responsible for organising/ performing Analytical Sciences testing of raw materials, excipients, in-process tests, drug substance characterisation and stability (where required) 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 project teams.

Responsible for writing and reviewing procedures to the required quality for cGMP compliance for all areas of Analytical Sciences and ensure traceability and documentation of the development and validation of the procedures.

Responsible for 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.

Responsible for performing housekeeping within the Analytical Sciences Laboratories, ensuring safety standards are maintained.

Responsible for co-ordinating any outsourcing required for projects assigned to you, when required and support the Snr Managers, Analytical Sciences in reporting work status.

Responsible for ensuring equipment logbooks are kept up to date and filled in using the appropriate guidelines.

Responsible for providing training to colleagues in analytical methods, as required.

Responsible for 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.

Identify and raise capex requests including justification of the need, impact assessment upon operations and the business through to successful implementation

Participate in 3rd party inspections, such as regulatory bodies, as required.

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

Maintain an up-to-date and accurate training record to meet all required operating procedures for activities and including ensuring all heath safety and environment training is complete

Provide periodic cover outside of normal working hours for essential operations

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

Experience and Qualifications required:


• BSc science graduate (or equivalent) with biopharmaceutical or pharmaceutical experience.
• Experienced in the analysis of biomolecules and beneficial to have experience in gene therapy products.
• Experience with biologics assay development/ optimisation and assay qualification.
• Working knowledge of analytical techniques including but not limited to:
• Electrophoresis (SDS-PAGE, Western Blot, IEF)
• Chromatography (SE-UPLC, RP-HPLC, AEX, HILIC)
• Immunoassays (ELISA, Potency, HCP)
• Experience of performing equipment qualification and test method validation
• Experience in writing technical protocols, reports and test methods including stability studies
• Clear understanding of the science and a passion for keeping abreast and implementing analytical advancements.

Personal Attributes:

 
• Excellent analytical skills with the ability to analyse, interpret results both reporting and communicating experimental findings effectively.
• Thorough with a high attention to detail, organised, adaptable, personable and technically competent.
• Ability to solve complex problems and making timely quality decisions based upon a mixture of analysis, experience and judgement.
• Experience in the use of statistical techniques for the planning and analysis of experiments.
• Demonstrable good oral and written communication and interpersonal skills.
• Ability to work effectively within a dynamic team and work independently.
• Aptitude for identifying and implementing new technologies.
• Excellent interpersonal skills with ability to influence outcomes.


Behaviours – linked to the Allergan BOLD culture

 

We Build Bridges with each other, customers and partners
We will use excellent interpersonal skills to build relationships internally and with external partners, such as CROs and CMOs. They will collaborate closely with Process Sciences throughout development and with Pharmaceutical Technology during process validation.

We Power Ideas that change healthcare
We will challenge “traditional” ways and strive for innovative solutions. They will solve complex problems with simple solutions.

We Act Fast to be responsive to customers and business opportunities
We will adapt to changing demands and be action oriented to overcome challenges. They will apply strong problem solving skills to resolve issues and seek simple solutions. They will be make quality decisions on outcomes.

We Drive Results and execute our plans
We will focus on strong planning, risk mitigation strategies and delivery. They will be push themselves and others to deliver and exceed the goals

Equal Employment Opportunity Employer


Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.

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