Physiochemical Method Scientist
A speciality biopharmaceutical company is currently recruiting a Physiochemical Method Scientist to join their office in Reykjavik. This organisation is renowned for its work on high-quality biosimilar products, ranging across the value chain from cell line development to commercial manufacturing. This is an exciting opportunity to work with a dynamic and upcoming company and bolster a career in the biosimilar space.
- Developing analytical methods, writing method development protocols and reports.
- Creating and processing analytical reports for biosimilarity exercises.
- Generating qualification/validation documentation and execute the validation of analytical methods.
- Using pipettes and other laboratory instruments.
- Performing routine cleaning, verification, and upkeep of laboratory and equipment.
- Performing stock checks.
- Providing technical training of level I analytical development scientists.
- Leading and giving guidance on relevant projects.
- Reviewing and completing laboratory documentation.
- Providing technical support where required.
- Performing any activities required to support testing, e.g. buffer preparation.
- Qualifying and optimising critical reagents, e.g. reference material.
- Identifying required document changes and updating of quality documentation
- Supporting change controls
- Initiating and leading change control
- Supporting and overseeing activities performed by level I scientists as and when required.
- Being aware of and complying with the company's current EHS policies.
- Working to and complying with the requirements of the company QMS cGMP and GDP Practises and Policies.
- Participating in self inspections and regulatory inspections.
Skills and Requirements:
- Minimum of a M.Sc. in a relevant scientific discipline and direct industry experience, or 5 years' experience in Pharmaceutical or Biopharmaceutical sector.
- Knowledge of GMP standards.
- Experience in analytical method development.
- Experience in the aforementioned methods.
- GxP experience, working in a QC laboratory.
- Demonstrable project management skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Owen Bach at +44 203 826 1330 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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