This role reports to the Senior Development Analyst/Team Leader and will primarily be responsible for conducting analytical activities, stability studies, validation and transfer methods. The role will be responsible for providing technical expertise at both a theoretical and practical level. The ideal candidate will therefore have a pharmaceutical analysis background and have gained experience within a cGMP, FDA and MHRA regulated environment.
To conduct analysis, stability studies, validation and transfer of methods
Key responsibilities and accountabilities:
1. Plan, implement, conduct and document stability studies
2. Conduct analysis to support stability studies
3. Analyse and report data accurately in a clear and concise manner
4. Perform method development and validation
5. Compilation of customer/client reports
6. Conduct data and write-up checking of reports generated by other laboratory personnel
Person Profile: Development Analyst
Results oriented with a positive outlook and clear focus on high quality output: Solid planning and organizational ability Reliable, tolerant and dependable: Comfortable dealing with senior managers, clients and customers: Enjoy working in a fast, stimulating environment. Goal-oriented: Able to work under pressure and meet deadlines Excellent communication/ presentation skills. Able to get on with others and be a team player, but is equally comfortable working independently.
Able to work extended hours should that be required
Specific Job Skills:
* A science degree in a relevant scientific discipline
* Direct experience with stability studies and data analysis.
* An understanding of the technical and practical skills involved stability studies, method development transfer and validation
* Proven ability to work to key regulatory and compliance requirements
* Skilled in analytical techniques eg HPLC, Dissolution and Gas Chromatography
* Able to communicate well via written media with specific emphasis on report writing.
* Able to work with minimal supervision.
* Experience of Dionex Chromeleon software
* Experience of stability studies within a pharmaceutical environment (with formulations of drug products for pre-clinical and clinical trials).
* Have a broad knowledge with and experience of working within a cGMP/GLP environment.
Computer skills: Must be adept in use of MS Office, particularly Excel and Word, internet and e-mail
Literacy and Numeracy: Must be a very competent in writing reports both for internal use and for customers/clients. Must be competent in interpreting data.
Business Presentation Skills: Must be an excellent face-to-face and telephone communicator.
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