Detalhe da Oferta:
GenIbet is a cGMP biopharmaceutical CDMO - Contract Development Manufacturing Organization - offering highly specialized nucleic acid, 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 supply.
RESPONSABILITIES:
o Responsible for coordinating the successful transfer of biologics manufacturing processes from clients to the CDMO. This involves managing information flow, documentation, timelines, deliverables and ensuring that the transferred processes meet regulatory and quality requirements
o Evaluate incoming client processes to identify potential risks, technical gaps, and optimization needs
o Perform gap assessments to ensure that the client’s process aligns with GenIbet’s capabilities and equipment
o Develop and execute a detailed tech transfer project plan, including timelines, budget and deliverables
o Serve as the primary liaison between clients, production and operations, quality control and quality assurance to coordinate all transfer activities
o Act as the primary technical point of contact for troubleshooting and resolving process-related issues in manufacturing
o Use data-driven approaches to investigate deviations, conduct root-cause analysis, and implement corrective actions to maintain process integrity
o Collaborate with clients to identify and implement opportunities for process improvements that enhance yield, reduce costs, or increase product quality
o Leverage data analytics and process monitoring tools to proactively identify trends and potential improvements
o Work closely with quality assurance to ensure that manufacturing processes are compliant with GMP, ICH, and other applicable standards
o Support audits and inspections by providing technical expertise, process data, and documentation as required
o Stay updated on emerging technologies and innovations in biologics manufacturing, evaluating their potential impact and feasibility for the organization
o Lead or support technology transfer for new equipment or systems that improve process efficiency or product quality
REQUIREMENTS:
• PhD/MSc in Biotechnology, Chemical/Biochemical Engineering, Pharmaceutical Sciences, Biochemistry or related sciences
• Minimum 2 -3 years of work experience in biotechnology
• Hands on experience in cell expansion (mammalian, insect cells, bacteria or yeast, cell-free)
• Hands on experience in purification processes (clarification, TFF, chromatography)
• Background in MSAT, Process Development, Scale-up and Tech Transfer
• Knowledge on Project Management tools, methodologies and techniques
• Proven track record of Project Management
• Knowledge in Good Manufacturing Practices (ideal)
• Knowledge in Tech Transfer (ideal)
• Pro-active and optimistic attitude
• Strong organizational skills and motivation to work within cross-functional teams
• Good team spirit and excellent leadership skills
• Experience managing resources and project teams in a matrix organization
• Flexibility and willingness to work with diverse areas and technologies
• Analytical skills and ability to make decisions under pressure
• Ability to work with tight deadlines and problem solving attitude
• Excellent Proficiency in spoken and written English
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 supply.
RESPONSABILITIES:
o Responsible for coordinating the successful transfer of biologics manufacturing processes from clients to the CDMO. This involves managing information flow, documentation, timelines, deliverables and ensuring that the transferred processes meet regulatory and quality requirements
o Evaluate incoming client processes to identify potential risks, technical gaps, and optimization needs
o Perform gap assessments to ensure that the client’s process aligns with GenIbet’s capabilities and equipment
o Develop and execute a detailed tech transfer project plan, including timelines, budget and deliverables
o Serve as the primary liaison between clients, production and operations, quality control and quality assurance to coordinate all transfer activities
o Act as the primary technical point of contact for troubleshooting and resolving process-related issues in manufacturing
o Use data-driven approaches to investigate deviations, conduct root-cause analysis, and implement corrective actions to maintain process integrity
o Collaborate with clients to identify and implement opportunities for process improvements that enhance yield, reduce costs, or increase product quality
o Leverage data analytics and process monitoring tools to proactively identify trends and potential improvements
o Work closely with quality assurance to ensure that manufacturing processes are compliant with GMP, ICH, and other applicable standards
o Support audits and inspections by providing technical expertise, process data, and documentation as required
o Stay updated on emerging technologies and innovations in biologics manufacturing, evaluating their potential impact and feasibility for the organization
o Lead or support technology transfer for new equipment or systems that improve process efficiency or product quality
REQUIREMENTS:
• PhD/MSc in Biotechnology, Chemical/Biochemical Engineering, Pharmaceutical Sciences, Biochemistry or related sciences
• Minimum 2 -3 years of work experience in biotechnology
• Hands on experience in cell expansion (mammalian, insect cells, bacteria or yeast, cell-free)
• Hands on experience in purification processes (clarification, TFF, chromatography)
• Background in MSAT, Process Development, Scale-up and Tech Transfer
• Knowledge on Project Management tools, methodologies and techniques
• Proven track record of Project Management
• Knowledge in Good Manufacturing Practices (ideal)
• Knowledge in Tech Transfer (ideal)
• Pro-active and optimistic attitude
• Strong organizational skills and motivation to work within cross-functional teams
• Good team spirit and excellent leadership skills
• Experience managing resources and project teams in a matrix organization
• Flexibility and willingness to work with diverse areas and technologies
• Analytical skills and ability to make decisions under pressure
• Ability to work with tight deadlines and problem solving attitude
• Excellent Proficiency in spoken and written English
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!