Detalhe da Oferta:
GenIbet is a cGMP biopharmaceutical CDMO - Contract Development Manufacturing Organization - offering highly specialized microbial, cell culture and viral process development and cGMP manufacturing services to research groups, biotech and pharma companies.
GenIbet's core activity is the manufacture and supply of materials for use in early-stage drug development, pre-clinical studies and cGMP manufacturing for clinical trials and commercial.
RESPONSABILITIES:
• Perform the physiochemical and microbiological analysis specifically required for in process product control, ensuring compliance with established procedures and current Good Manufacturing Practice (cGMP);
• Perform the sampling of raw materials and packaging materials, ensuring compliance with established procedures and current Good Manufacturing Practice (cGMP);
• Perform routine environmental monitoring of the manufacturing facilities and support areas according to the procedures in place;
• Perform the sampling and analysis of water for injectables (WFI), according to the procedures in place;
• Support QC investigation on deviations or OOS events;
• Support QC team in the preparation of protocols for the implementation of new assays/methods;
• Guarantee Quality Control’s facilities continuous monitoring, ensuring the laboratories are clean and organized.
• This person will execute routine analyses to support the manufacture of the first FDA-approved oral microbiome product
REQUIREMENTS:
• Degree in Microbiology, Biology, Biotechnology or Engineering Sciences (Chemical, Biochemical, Biological or similar) or certification in vocational course in QC Microbiology techniques;
• Minimum 1-2 years of work experience in similar roles in pharmaceutical industry;
• Knowledge of Good Manufacturing Practices;
• Strong organizational skills and motivation to work in an innovative industry;
• Flexibility to work in 2 shifts (8h-15h and 15h-01h am);
• Good team spirit;
• Good knowledge of English.
OFFERED:
o Competitive salary and attractive benefits
o Opportunities for professional growth and development
o Innovative and collaborative working environment
o Participation in challenging projects with a global impact.
HOW TO APPLY: Send your CV to
Be part of a team that is changing the future in the field of Biologics with innovation, passion and excellence. We look forward to receiving your application!
GenIbet's core activity is the manufacture and supply of materials for use in early-stage drug development, pre-clinical studies and cGMP manufacturing for clinical trials and commercial.
RESPONSABILITIES:
• Perform the physiochemical and microbiological analysis specifically required for in process product control, ensuring compliance with established procedures and current Good Manufacturing Practice (cGMP);
• Perform the sampling of raw materials and packaging materials, ensuring compliance with established procedures and current Good Manufacturing Practice (cGMP);
• Perform routine environmental monitoring of the manufacturing facilities and support areas according to the procedures in place;
• Perform the sampling and analysis of water for injectables (WFI), according to the procedures in place;
• Support QC investigation on deviations or OOS events;
• Support QC team in the preparation of protocols for the implementation of new assays/methods;
• Guarantee Quality Control’s facilities continuous monitoring, ensuring the laboratories are clean and organized.
• This person will execute routine analyses to support the manufacture of the first FDA-approved oral microbiome product
REQUIREMENTS:
• Degree in Microbiology, Biology, Biotechnology or Engineering Sciences (Chemical, Biochemical, Biological or similar) or certification in vocational course in QC Microbiology techniques;
• Minimum 1-2 years of work experience in similar roles in pharmaceutical industry;
• Knowledge of Good Manufacturing Practices;
• Strong organizational skills and motivation to work in an innovative industry;
• Flexibility to work in 2 shifts (8h-15h and 15h-01h am);
• Good team spirit;
• Good knowledge of English.
OFFERED:
o Competitive salary and attractive benefits
o Opportunities for professional growth and development
o Innovative and collaborative working environment
o Participation in challenging projects with a global impact.
HOW TO APPLY: Send your CV to
Be part of a team that is changing the future in the field of Biologics with innovation, passion and excellence. We look forward to receiving your application!