Extractables and Leachables Risk Assessor, Open to flexible working
Exciting opportunity for an enthusiastic individual to join a trace analysis and extractable and leachable (E&L) team in an industry leading bio pharmaceutical company.
The successful candidate will primarily undertake E&L focussed risk assessments using Failure Mode and Effects Analysis (FMEA) to provide key information in support of the company's diverse development portfolio of medicinal products. The successful candidate will work with a high level of autonomy and contribute to analytical projects (from initial risk assessments through to final report) as well as inputting into the development of trace level control strategies for individual projects, contributing to regulatory submissions and overseeing completion of work packages placed at CROs. T he successful candidate must be a high calibre graduate or a PhD with at least 5 years' experience performing FMEA based risk assessments with a knowledge of the biopharmaceutical industry .
Primary responsibilities include:
- Conducting and documentation of FMEA risk assessments for biopharmaceutical drug substance and drug product manufacturing processes, container closure systems and dosing devices.
- Identification and design of technical work packages to support risk mitigation activities
- Authoring of technical documentation
- Project management and contribution to regulatory submissions
- BSc or PhD in Chemistry , Materials Science or related field
- Strong communication, project management and interpersonal skills
- Ability to work independently and problem solve with a track record of generating high quality data and reports
- Previous experience conducting FMEA risk assessments
- Development of trace level control strategies for individual projects
- Understanding of analytical chemistry , in particular, the control of trace level extractables and leachables
- Knowledge of biopharmaceutical single use systems
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