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Senior Analytical Chemist

Medical Devices

Surrey (£) Competitive
permanent Job Ref: 5665

Description

A leading medical device company has an exciting opportunity for a Senior Analytical Scientist to join its team. You will join a busy R&D lab providing expertise in the method development, validation and transfer of MS based methods.  You will be an experienced chemist with the ability to hit the ground running.  Your experience must have been gained within the pharmaceutical or medical device industry.

The role:

The role of Senior Analytical Scientist within the Product Development Team is to ensure that the quality and performance of the new products under development are characterised in accordance to their applicable Key/Critical Quality Attributes. It will also provide an oversight and direction in all method development supporting Product Development. The role will sit alongside the Process Development and the Design Development pillars of the Product Development Team and will work closely with the Laboratory Manager.

Principal Responsibilities

1.    Analytical technical lead in the Product Development Team, covering the development and the characterisation of device products under Development and Design Control

2.    Lead the technical development of analytical assays and product characterisation methods supporting device/drug/combination products (both in-house and through third party)

3.    Provide guidance and oversight to a small characterisation team with possible future Line Management opportunities

4.    Act as the Interface between R&D and Quality Control ensuring that the developed methods are fit for transfer into a GMP operating area and lead the method transfer from the Sending Unit (R&D)

5.    Work closely with the Project Technical Leads to ensure that analytical and product characterisation method development matches the expectations based on the project stage and regulatory requirements

6.    Work closely with the Laboratory Manager to ensure that Processes and Plant related to the product characterisation are fit for purpose and accounted for in the budget

7.    Write and provide direction in writing SOPs and Work Instructions required for executing characterisation techniques

8.    Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with company values.

9.    Carry out other reasonable tasks as required by the Line Manager.

Education and Experience

  • A minimum of a Bachelor of Science Degree or equivalent qualification is required.
  • Experience managing and coordinating technical programmes, generating technical data and delivering high quality reports and/or presentations of findings
  • Experience working in a regulated industry, preferably medical devices and/or pharmaceutical
  • Competent in chemical/physical/biological characterisation of materials and devices, investigative techniques and technical writing
  • Extensive method development experience and knowledge
  • Extensive experience of LC/GC-MS, spectroscopy & microscopy techniques required
  • Experience in user interface testing (Human Factor) and elution techniques strongly recommended
  • Experience in rheology and fluid dynamics desired
  • Knowledge of ISO13485, ICH Q1/Q2/Q3/Q8 Guidelines desired
  • Experience of Third party interaction recommended

Skills and Attributes

  • Strong technical ability to grasp company products, their application and use in a medical setting
  • Strong problem solving skills with an attention to detail and a creative approach to achieving tasks
  • Positive attitude with a desire to deliver to schedule
  • Good written and verbal communication skills.  Excellent report writing skills.  Capable and confident presenting and communicating expert knowledge and concepts at various levels appropriate with the audience.
  • Capable to work well within a team motivating self and others to achieve objectives
  • Excellent organisation and self-discipline with planning and completing tasks
  • Competent with MS Office suite (Word, Excel, PowerPoint etc.) and preferably Waters Empower Chromatography Data software
  • Proactive & diligent

Competitive salary and benefits package

Job Ref: 5665