Essential Functions of the Job (Key responsibilities)
- Performs the QC analysis to support raw materials, production release and stability plan of drug substance (HPLC, UPLC, CGE, pH, FTIR, Osmolality, Protein Concentration or ELISA tests, appearance).
- Performs the review of analytical data.
- Act as a a key user for QC equipment software and method setup.
- Performs basic laboratory work (buffer preparation, waste disposal management, washing of lab dishes, cleaning of the labs etc.).
- Proactively propose problem resolutions
- Efficiently contribute to method tech transfer.
- Author, review and maintain Standard Operating Procedures, Work Instructions, and other quality control documents.
- Supports selection, purchase and commissioning of new equipment.
- Supports management supply of QC consumables, reagents and standards.
- Supports maintenance/calibration of equipment and keeps relationship with suppliers.
- Contribute to the efficient management of samples.
- Proactively propose problem resolutions.
- Raise, investigate and close events, deviations and non-conformances.
- Contribute positively to a strong culture of business integrity and ethics.
- Act within compliance and legal requirements as well as within company guidelines.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- CFC or higher degree in analytical chemistry/biochemistry
- At least 5 years’ experience in the biotech, pharmaceutical or chemical environment
- Hands-on experience in a GMP environment and a Quality Control environment.
- Good knowledge of analytical method transfer and analytical method validation.
- Solid knowledge in spectroscopic, HPLC, CE and ELISA techniques.
- Solid knowledge of Empower or Soft Max PRO.
- Good writing skills.
- Excellent team spirit.
- Autonomy
- French: Native or Fluent
- English: Good knowledge
- Knowledge of most common office software.
- Work the weekend may be required.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .
