Overview

Analytical Scientist

Analytical Scientist – Pharmaceuticals – Cambridgeshire

Job purpose
To support the company in the manufacture of their products, by performing the testing required under GMP guidelines. e.g. raw materials, API’s and cleaning samples etc.
To support them in the development and testing of its novel autoinjector technology through laboratory-based work. This includes leading project activities involving the introduction, development and execution of test methods and programmes for prototype mechanisms, quality inspection procedures as well as research into and early-stage development of parenteral drug formulations and analytical methods.

Overview of Main Duties and Responsibilities

* Lead project activities involving analytical and testing procedures to meet project deadlines

* Work with the existing team of engineers and designers to:

1. Develop, implement, and execute inspection / metrology programmes to enable the release of incoming product

2. Develop, implement, and execute test programmes to enable the characterisation, verification, and release of product functionality / mechanisms

3. Assist in the development of manufacture processes

* Manage the stability programme, producing protocols, organise trials and performing data trending

* Use and support company IT systems and equipment software

* Work with and support quality and safe working practice procedures

* Creation of technical documentation (including protocols and reports) which adhere to the requirements of ISO13485 and GMP

* Experienced in using HPLC and other analytical techniques under GMP guidelines

* Provide guidance and training to junior team members

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Personal characteristics

* Self-motivated, energetic and positive nature

* Adaptable, resourceful and creative

* Open, honest, inclusive, personable

* A team player with good interpersonal and communication skills

* Able to travel when required (infrequent)

* A ‘finisher’

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Experience/Skills needed to fulfil the role:

* Good analytical technique

* Methodical approach with attention to detail

* Good written English language skills

* Logical approach to problem solving

* Proficient in Microsoft Office

* Strong background in science

* Good Manufacturing Practice experience

* Familiarity with ICH Guidelines for stability trials

Qualifications required

* Degree in a scientific discipline desirable, or qualified by experience