QC Associate

etherna immunotherapies; Niel; Sur place; EUR 45 000 - 70 000; Plein temps

Résumé du poste

etherna immunotherapies is seeking a QC Associate based in Niel, Belgium, to perform routine QC and Process Development testing in support of mRNA Drug Substance and Drug Product manufacturing. You will help ensure methods stay fit for purpose across the product lifecycle and collaborate with Process Development to align analytical activities with manufacturing goals.

The role requires hands-on testing, data reporting, and maintaining cGMP-compliant documentation in a cleanroom environment.

Qualifications

• Hands-on analytical testing in QC and Process Development.
• Ensures methods are fit for purpose throughout product lifecycle.
• Supports mRNA drug substance and drug product development.

Responsabilités

• Perform routine QC and Process Development testing including release and stability assays.
• Prepare reagents, manage samples, reagents, consumables stock.
• Maintain equipment and keep lab housekeeping.

Connaissances

qPCR

Slot Blot

Western Blot

SDS-PAGE

Spectrophotometry

Fluorimetry

Capillary Gel Electrophoresis

Sequencing

ELISA

Flow Cytometry

QC Testing

Stability Testing

Outils

qPCR equipment

Slot Blot apparatus

Western blot apparatus

SDS-PAGE system

ELISA reader

Flow cytometer

Description du poste

The QC Associate is a hands-on person responsible for performing routine analytical testing in support of Quality Control and Process Development and performing general laboratory operations in support of mRNA drug substance and drug product manufacturing. He/she assists in the different aspects of the method lifecycle within QC to ensure that methods are fit for their intended purpose throughout the product lifecycle. The QC Associate is a member of the QC department. This position reports into the QC Manager and will be based in Niel, Belgium.

Responsibilities and duties

The QC Associate’s duties shall include, but not be limited to:

• Primary responsibility will be performing general QC and Process Development routine characterization, release and stability testing and performing general laboratory operations including reagent preparation and qualification, sample/reagent/consumables stock management, equipment maintenance, lab housekeeping etc.
• Document and report data and results in accordance with the current procedures, protocols and cGMP regulations and interpret generated data for compliance towards method criteria and specifications.
• Report interim stability data, perform trending and write stability reports to determine the final product shelf-life and expiry date
• Assist in the phase-appropriate development, qualification/validation, implementation and transfer of QC methods (e.g., qPCR, Slot Blot, Western Blot, SDSPAGE, Spectrophotometry, Fluorimetry, Capillary Gel Electrophoresis, Sequencing, ELISA, Flow Cytometry, …) to support the manufacturing, characterization and release of DNA start material, raw materials, lipids, mRNA Drug Substance and Drug Product.
• Interact very closely with the Process Development department regarding analytical support in order to ensure that Process Development and QC activities are aligned with respect to process improvement.
• Write and revise procedures, protocols and reports to support the QC test method lifecycle.
• Assist in the planning, coordination and execution of required activities related to etherna’s stability and environmental monitoring programs.
• Assist in on-time implementation of documentation in support of the Environmental Monitoring program.
• Report interim EM data, perform trending and write trend report reports to ensure manufacturing of mRNA Drug Substance and Drug Product in a controlled cGMP cleanroom environment
• Update and review of master batch records and QC-related documentation in support of GMP manufacturing.
• Monitor QC method performance and perform investigations under supervision related to QC method and equipment failures and non-conformance events and escalat... correctly?==