Essential Functions/Responsibilities
1. Operates in accordance with the Jazz corporate values of being patient driven, passionate, innovative, collaborative, accountable, having integrity and achieving excellence.
2. The job holder is responsible for maintaining cGxP and EH&S knowledge applicable to the job.
3. Provides support to own team and understands priorities of others.
4. Builds productive internal relationships mainly within own area of work with some broader functional interaction.
5. Perform analytical testing for research and IMP release.
6. Ensure at all times that Good Practice is followed and all areas are maintained to the appropriate standards.
7. Record all experimental outcomes in an appropriate format.
8. Maintain all working areas in clean and tidy state.
9. Ensure all applicable quality measures are met and adhered to.
10. Assist in the creation and maintenance of all relevant cGxP documents.
11. Analyse and report results for starting materials, intermediates, API and drug product for use as Investigational Medicinal Products.
12. Perform all necessary testing in accordance with company procedures.
13. Take part in authoring specifications, test methods and other analytical procedures.
14. Support analytical method transfers to other laboratories.
15. Support qualification and maintenance of the analytical facilities and equipment.
16. Take part in appropriate validation activities.
17. Ensure training records are kept up to date in accordance with company procedures.
18. Promptly notify the management about OOS/OOT/OOE and take part in investigation as per company procedures.
19. Take part in scheduling, testing, and reporting for development stability programmes.
20. Support management of reference standards and retained samples within the department (as appropriate to the role).
Required Knowledge, Skills, and Abilities
1. Practical understanding in a range of scientific skills and technologies (e.g. HPLC/GC, Dissolution, wet chemistry) and ability to interpret generated data. Demonstrated ability to perform phase appropriate method development and validation for API and drug product.
2. Proven ability to write analytical test methods, specifications, method development/validation protocols, and method development/validation reports. Demonstrated ability to support lab investigations.
3. Thorough working knowledge of Microsoft Office packages.
4. High level of numeracy.
5. Communication skills including written and presentational.
6. Excellent attention to detail.
7. Collaborative team player.
8. Pro-active approach to problem solving.
9. Ability to coach and mentor less experienced colleagues.
10. Able to develop and maintain positive working relationships with others.
Required/Preferred Education and Licenses
1. Required: A relevant Science degree and/or relevant experience.
2. Preferred: Higher qualification (e.g. MSc/PhD) in relevant topic. Awareness of basic statistical principles.
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