:
1. Analytical Testing: Perform analytical tests to support method development and batch release according to established procedures and documentation.
2. Method Transfer & Training: Contribute to analytical method implementation and train colleagues as needed.
3. Documentation: Ensure accurate and traceable completion of all relevant documentation.
4. Equipment Management: Support equipment maintenance and report any deviations or malfunctions.
5. Logistics & Inventory: Use systems like SAP to manage samples, reagents, and materials; ensure proper storage and shipment.
6. Quality Compliance: Adhere to internal quality systems (GMP, GDP, GLP); complete required training.
7. Audit Support: Present activities and documentation during audits or inspections.
8. Team Collaboration: Communicate effectively and work closely with cross-functional teams.
Qualifications:
9. Education: Bachelor’s or Master’s in Biochemistry, Molecular/Cell Biology, or Chemistry (or equivalent experience).
10. Technical Skills: Experience in one or more of the following:
Chromatography (SEC-MALS, RP-HPLC, IEX-HPLC)
Protein chemistry (SDS-PAGE, Western Blot, DLS)
Bioassays (qPCR, ddPCR, ELISA, potency assays, infectivity titers)
Aseptic techniques (BSL2 environment)
11. Personal Qualities: Autonomous, curious, organized, responsible, adaptable, reliable, open-minded, and positive.
12. IT Skills: Proficient with MS Office; experience with SAP and Documentum is a plus.
Experience:
Minimum 1 year of relevant experience in an industrial or pharmaceutical environment. Solid understanding of GMP, GDP, and GLP standards.