Technician QC Physico Chemistry

Incyte Corporation; Lavamünd; Hybrid; EUR 45.000 - 65.000; Vollzeit

Zusammenfassung

Incyte Corporation is seeking a QC Technician Physico Chemistry to perform QC analyses (HPLC, UPLC, CGE, ELISA, FTIR) and to support raw materials, production release, and stability testing. You will author procedures, participate in method transfer, and ensure quality control documentation.

The role requires a GMP background, experience with Empower or Soft Max PRO, and strong writing and teamwork abilities. Weekend work may be required, with on-site duties in a biotech setting.

Qualifikationen

• CFC or higher degree in analytical chemistry/biochemistry.
• At least 5 years’ experience in biotech/pharmaceutical/chemical environments.
• GMP and Quality Control experience.
• Knowledge of analytical method transfer and validation.
• Solid knowledge of spectroscopy, HPLC, CE and ELISA.
• Experience with Empower or Soft Max PRO.
• Good writing skills.
• Strong teamwork and autonomy.
• Weekend work may be required.

Aufgaben

• Performs QC analysis to support materials, production release and stability plans.
• Reviews analytical data.
• Acts as a key user for QC software and method setup.
• Performs basic lab work and waste management.
• Proposes problem resolutions and supports method transfer.
• Authors and maintains SOPs and lab documents.
• Supports equipment selection and commissioning.
• Supports supply of QC consumables and standards.
• Maintains equipment calibration and supplier relations.
• Contributes to sample management and deviation investigations.

Kenntnisse

HPLC

UPLC

CGE

ELISA

FTIR

Osmolality

Protein concentration

Analytical data review

Autonomy

Team spirit

Good writing skills

Ausbildung

CFC or higher degree in analytical chemistry/biochemistry

Tools

Empower

Soft Max PRO

Jobbeschreibung

Aperèc

The QC Technician Physico Chemistry performsQC analysis to support production and release of drug substance, stability testing. The QC Technician Physico Chemistry also actively participate to new product introduction and method transfer. He/she also authors the analytical procedures and the general QC procedures.

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.