Biotech Cell Therapy Process Development Expert
3 dagen geleden
Galapagos, a pioneering Biotech company headquartered in Mechelen, Belgium, is seeking a highly motivated (Senior) Process Engineer to join its Cell & Gene Therapy organization in Leiden/NL.
The successful candidate will be a subject matter expert on manufacturing processes during operations and Technology Transfer activities of automated CAR-T, driving operations from site selection through clinical/pivotal/commercial readiness.
Key Responsibilities- Lead technology transfers and clinical manufacturing activities, including process performance qualification, aseptic process validation, regulatory submissions, scale-out, process training, and technical support.
- Triage operational challenges and deviations with internal stakeholders and Point-of-Care Manufacturing units (PMUs) to ensure compliance and qualification/batch progress.
- Develop and maintain digital and automated cell culturing platforms for consistency and control of cell therapy manufacturing processes.
- Analyze data for Key Performance Indicators related to operational performance.
- Collaborate with external stakeholders and vendors to drive improvements in equipment, facilities, and engineering workstreams.
A competitive salary of approximately €65,000-€80,000 per year, commensurate with experience, is offered for this exciting opportunity.
-
Scientist Process Development CAR
1 maand geleden
Leiden, Zuid-Holland, Nederland Galapagos VoltijdWe're a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.We pioneer for patients, discovering and developing life-improving medicines. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists.For our Cell & Gene...
-
Strategic Director of Cell Therapy Quality Assurance
4 weken geleden
Leiden, Zuid-Holland, Nederland Galapagos VoltijdWe're looking for a Strategic Director of Cell Therapy Quality Assurance to join our team at Galapagos, a dynamic growing Biotech company. In this role, you will play a key part in shaping our strategic directions, collaborating closely with internal and external stakeholders as we rapidly scale up our activities in Europe and the US.Your Key...
-
Key Performance Manager in Cell Therapy Manufacturing
2 weken geleden
Leiden, Zuid-Holland, Nederland Galapagos VoltijdGalapagos, a pioneering biotech company with offices across Europe and the US, headquartered in Mechelen, Belgium, is looking for a highly skilled professional to drive continuous improvement initiatives in its cell therapy manufacturing organization.The ideal candidate will have a passion for excellence, a track record of process improvement success, and a...
-
Process Engineer: Driving Innovation in Cell
3 weken geleden
Leiden, Zuid-Holland, Nederland Galapagos Voltijd{"At Galapagos, we’re committed to changing lives through innovative biotech solutions. As a highly motivated Cell & Gene Therapy organization in Leiden/NL, we’re seeking a visionary (Senior) Process Engineer to join the Point-of-Care Manufacturing team (PoC)\. This team provides technical-operational expertise to the GMP operations at...
-
Cell Therapy Quality Assurance Strategist
1 week geleden
Leiden, Zuid-Holland, Nederland Galapagos VoltijdWe are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.Our mission is to change lives by discovering and developing life-improving medicines that go where no one has ever gone before. We pioneer for patients and need thought leaders and rapid thinkers who are entrepreneurs in spirit...
-
Cell Therapy Quality Assurance Director
22 uur geleden
Leiden, Zuid-Holland, Nederland Galapagos VoltijdWe are Galapagos, a dynamic and growing Biotech company with offices across Europe and the US, headquartered in Mechelen, Belgium.We're in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need...
-
Senior Process Engineer
1 maand geleden
Leiden, Zuid-Holland, Nederland Galapagos VoltijdWe are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.We're in the business of changing lives. In our quest to discover and develop life-improving medicines, we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need...
-
Biotech QA Specialist
2 weken geleden
Leiden, Zuid-Holland, Nederland Galapagos VoltijdWe are Galapagos, a dynamic growing biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.We pioneer for patients, discovering and developing life-improving medicines that change lives. We need thought leaders and rapid thinkers who are entrepreneurs at heart and status quo-fighters. Collaborative innovators and...
-
Head of Quality Assurance Cell Therapy
1 maand geleden
Leiden, Zuid-Holland, Nederland Galapagos VoltijdWe are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.We're in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need...
-
Cell and Gene Therapy Regulatory Expert – Senior Consultant
3 weken geleden
Leiden, Zuid-Holland, Nederland ProPharma Group VoltijdProPharma Group is seeking a highly experienced Cell and Gene Therapy Regulatory Expert to join our team as a Senior Consultant.Key Responsibilities:Act as a key Subject Matter Expert in assigned areas of quality assurance and regulatory/GxP.Provide Independent consultation with clients and project leadership to a range of challenging and fascinating...
-
Director of Cell Therapy Manufacturing Operations
4 weken geleden
Leiden, Zuid-Holland, Nederland Leiden Bio Science Park VoltijdGrow with Us:At Leiden Bio Science Park, we prioritize your professional growth and development, fostering a culture of empowerment. Our dedicated team members are the driving force behind our mission to lead in pharmaceutical research and innovation.What We Offer:A competitive compensation package that recognizes your worth and supports your well-being.A...
-
Biotech Excellence Lead
2 weken geleden
Leiden, Zuid-Holland, Nederland Galapagos VoltijdWe're Galapagos, a dynamic growing Biotech company with offices across Europe and the US, headquartered in Mechelen, Belgium.Our mission is to change lives by discovering and developing life-improving medicines. We pioneer for patients, seeking thought leaders and rapid thinkers who are entrepreneurs at heart and status quo-fighters.We need collaborative...
-
Cell Therapy Production Specialist
2 weken geleden
Leiden, Zuid-Holland, Nederland Oxford Global Resources VoltijdOxford Global Resources is a leading biotechnology company at the forefront of developing innovative CAR-T immune therapies for cancer treatment. Our cutting-edge technologies, such as point-of-care cell therapy production models, enable us to provide efficient and effective treatment options.**Job Summary:**We are seeking an experienced Senior Operator/SME...
-
Scientist Process Development CAR
2 weken geleden
Leiden, Zuid-Holland, Nederland Galapagos VoltijdWe are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.We're in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need...
-
Cell Therapy Quality Assurance Director
2 weken geleden
Leiden, Zuid-Holland, Nederland Galapagos VoltijdWe are looking for a Cell Therapy Quality Assurance Director to join our team at Galapagos.Job DescriptionAs our Head of Quality Assurance Cell Therapy, you will play a key role in shaping strategic directions in close collaboration with QC, Manufacturing, Supply Chain and other internal and external stakeholders as we are rapidly scaling up our activities...
-
Materials Quality Expert for Cell Therapy
1 week geleden
Leiden, Zuid-Holland, Nederland Galapagos VoltijdAt Galapagos, a pioneering Biotech company with global presence, we're driven by a singular purpose: to change lives through life-improving medicines. With headquarters in Mechelen, Belgium, and offices across Europe and the US, we're shaping the future of healthcare.We're seeking a highly skilled Materials Quality Consultant to join our Cell Therapy...
-
Leiden, Zuid-Holland, Nederland Galapagos VoltijdWe are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium. As a pioneering company in life-improving medicines, we seek innovative minds to join our Cell & Gene Therapy organization in Leiden/NL.About the Role:As our Senior QA Specialist, you will play a crucial part in setting up,...
-
Manufacturing Associate
1 maand geleden
Leiden, Zuid-Holland, Nederland Bristol-Myers Squibb VoltijdTransforming Patients' Lives through ScienceAt Bristol Myers Squibb, we are committed to delivering innovative solutions that transform patients' lives. As a Manufacturing Associate - Cell Therapy, you will play a critical role in our mission to bring life-changing treatments to patients suffering from blood cancer.About the RoleThis is a unique opportunity...
-
Cell and Gene Therapy Specialist
2 weken geleden
Leiden, Zuid-Holland, Nederland ProPharma Group VoltijdAt ProPharma Group, we are seeking a seasoned Cell and Gene Therapy Specialist to join our team as a Regulatory Compliance Expert. This is an exciting opportunity for a highly skilled professional to spearhead challenging projects across the CQA space and contribute to the success of our clients in the EU.
-
Manufacturing Manager for Operational Excellence
3 weken geleden
Leiden, Zuid-Holland, Nederland Galapagos VoltijdWe are Galapagos, a dynamic growing Biotech company.We are looking for a Manufacturing Manager Operational Excellence to join our Cell therapy Manufacturing organization.Key Responsibilities:Lead initiatives of operational excellence in the decentralized network of point-of-care manufacturing sites.Utilize data analysis tools and metrics to identify process...