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