QC Analytical Product Testing Senior scientist
Alvotech · Reykjavík
The Quality Control department at Alvotech is looking for a dedicated and quality-minded QC Analytical Product Testing Senior scientist with extensive experience in the field, who will be a part of the Quality control team responsible for quality control and release testing of product manufactured at Alvotech.
Scope and responsibility:
- Performs routine analytical testing using advanced analytical techniques including Chromatography, Electrophoresis, Compendial and functional testing to support stability, in-process and release analysis.
- Expertise in selected analytical techniques and through understanding and overview of all analytical methods applied for product testing and stability testing.
- Be aware of compendia and routine testing equipment used during product testing
- Complete laboratory documentation and records in accordance with Good Documentation Practices (GDP).
- Proactively communicate analytical issues, deviations, and concerns to relevant stakeholders.
- Review and verify analytical data and test results.
- Support and lead CAPAs, change control, Document change controls and the investigations for quality issues such as Invalid assay, OOS/OOT/OOE results.
- Review and approve technical documentation within the document management system, as required.
- Provide support and oversight to other scientists in the laboratory
- Proactively ensure the QC Analytical laboratory and equipment is at all times maintained in a state of Inspection readiness.
- Perform training of other scientist in laboratory activities and specific methods.
- Creates and updates documents for analytical methods
- Knowledge about basic tasks in the labs and responsible for analytical methods.
- Actively involved and contributes to cross functional activities.
Job requirements:
- Minimum M.S in technical discipline, (e.g., pharmacy, biotechnology, biochemistry, or a related field)
- 5-10 years of experience in Pharmaceutical or Biopharmaceutical industry and preferably a project management background/exposure.
- Good conceptual, problem solving, and organizational skills – must be detail-oriented and able to work independently and in teams
- Independence in assignments. Routinely leads projects and/or supervises small or medium teams. Additionally takes part in larger projects.
- Expert knowledge within field of expertise such as methods, techniques as well as relevant procedural/process knowledge
- Open to flexible working hours.
- Excellent written and verbal communication skills.
What we offer:
- An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
- The chance to be a part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration and inclusion.
- Positive, flexible, and innovative work environment.
- Support for personal growth and internal career development.
- Company social events and milestone celebrations.
- Excellent in-house canteen and coffee house.
- Exercise and wellbeing support for full-time employees.
- On-site shower facility.
- Transportation grant towards eco-friendly modes of travel for full-time employees.
- Internet at home for full-time employees.