Technician QC Physico Chemistry

Incyte; Yverdon-les-Bains; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Incyte is seeking a QC Technician Physico Chemistry to perform QC analyses supporting production release and stability testing of drug substances. You will author and maintain analytical procedures, contribute to method transfers, and ensure data reviews align with GMP standards.

The role involves basic lab duties, equipment software support, and collaboration with QA to maintain quality and compliance. Fluent French and good English are preferred, with weekend work possible.

Qualifikationen

• CFC or higher degree in analytical chemistry/biochemistry.
• At least 5 years' experience in biotech/pharmaceutical or chemical environments.
• GMP environment experience in QC and QA.
• Proficient in analytical method transfer and validation.
• Solid knowledge of spectroscopic, HPLC, CE and ELISA techniques.
• Experience with Empower or SoftMax PRO.
• Good writing and teamwork skills.
• Autonomy; weekend work may be required.
• French: native or fluent; English: good knowledge.

Aufgaben

• Performs QC analysis to support raw materials, production release and stability testing of drug substance.
• Reviews analytical data critically for release decisions.
• Acts as a key user for QC equipment software and method setup.
• Performs basic lab duties and supports maintaining lab cleanliness.
• Contributes to method transfer and validation activities.
• Author and maintain SOPs, WIs and QC documents.
• Supports selection and commissioning of new QC equipment.
• Maintains QC consumables, reagents and standards.
• Ensures compliance with GMP and company guidelines.

Kenntnisse

QC analysis

HPLC/UPLC

ELISA

SOP writing

Method transfer

Analytical data review

Office basics

Ausbildung

CFC or higher degree in analytical chemistry/biochemistry

Tools

Empower

SoftMax PRO

Jobbeschreibung

Job Summary (Primary Function)

The QC Technician Physico Chemistry performs QC 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.

Aperçu

Job Summary (Primary Function)

The QC Technician Physico Chemistry performs QC 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.