20- years’ experience in operations and business leadership.
Among other companies, I have worked for General Electric, Johnson & Johnson, University of Pennsylvania (Gene therapy program), Novartis and Kiromic.
Novartis. I was in the operations leadership team which launched Kymriah the first cell therapy approved by the FDA. I was Head of Operations Excellence and Strategy, there I was program managing the whole operations set up, including scaling up production, retrofitting 2 clean rooms, regulatory roadmap and hiring and qualifying over 200 people.
University of Pennsylvania. I was the Executive Director of manufacturing at the Gene Therapy Program, responsible for the clinical and preclinical manufacturing group, including CDMO management, designing and building the manufacturing facility for clinical viral vector production, hiring of personnel and designing the quality system.
Kiromic pharma. I was the Chief Manufacturing and Chief Operating Officer at Kiromic a cell therapy company, where I scaled up operations, designed and built 7 clean room for manufacturing of cell therapy and viral vector for clinical phase, designed the QA system (managed a remediation plan to bring QA to clinical standards), hiring of personnel and CDMO management.
As independent consultant (to mention some):
1. CDMO client: set up operations for cell therapy clients. As per my referral, they are also working with 2 of my clients in the US.
2. Cell therapy (Clinical phase): Allogeneic NK cell, acting CTO
3. Cell therapy (Clinical and commercial phase): assessment of technical operations set up, including cost per vial, organization set, GRex performance and plan to reduce cost per vial 10x times.
Among other companies, I have worked for General Electric, Johnson & Johnson, University of Pennsylvania (Gene therapy program), Novartis and Kiromic.
Novartis. I was in the operations leadership team which launched Kymriah the first cell therapy approved by the FDA. I was Head of Operations Excellence and Strategy, there I was program managing the whole operations set up, including scaling up production, retrofitting 2 clean rooms, regulatory roadmap and hiring and qualifying over 200 people.
University of Pennsylvania. I was the Executive Director of manufacturing at the Gene Therapy Program, responsible for the clinical and preclinical manufacturing group, including CDMO management, designing and building the manufacturing facility for clinical viral vector production, hiring of personnel and designing the quality system.
Kiromic pharma. I was the Chief Manufacturing and Chief Operating Officer at Kiromic a cell therapy company, where I scaled up operations, designed and built 7 clean room for manufacturing of cell therapy and viral vector for clinical phase, designed the QA system (managed a remediation plan to bring QA to clinical standards), hiring of personnel and CDMO management.
As independent consultant (to mention some):
1. CDMO client: set up operations for cell therapy clients. As per my referral, they are also working with 2 of my clients in the US.
2. Cell therapy (Clinical phase): Allogeneic NK cell, acting CTO
3. Cell therapy (Clinical and commercial phase): assessment of technical operations set up, including cost per vial, organization set, GRex performance and plan to reduce cost per vial 10x times.