An NSF International Company Christof Langer
Consultant
MBA
- [email protected]
- +44(0)1751 432999
Christof is an established and recognised expert in the quality assurance of sterile products including biologicals, vaccines, and early phase formulations. His experience in delivering inspection readiness across a range of organisations is first class and he is an accomplished GMP auditor in this field.
As an associate of NSF Health Sciences, Christof brings proven expertise in:
- FDA/EMA pre-approval inspection readiness and corrective/preventive action plans
- GxP inspections and any subsequent upgrades to the quality management system
- Scientific/technical advice for drug PR activities
- Feasibility studies for production and market launch of drug products
- Process & QA guidance for manufacturing at routine and clinical stage
- Consulting for building, roll-out, and management of API and biologics manufacturing sites
Previously Managing Director of Baxter Bioscience sarl in Neuchatel, responsible for supply of a unique recombinant Factor VIII formulation, Christof managed a team of 500 and had a budget responsibility of $80m pa. Driving a culture of continuous improvement and utilising critical path analysis, his team ensured order fulfilment reached 100% on time in full. At this time, he led a programme that invested $10m in capital investment to improve plant capacity and achieved six keynote regulatory inspections without adverse observations.
Prior to this, Christof was Managing Director at Baxter s.r.o. in the Czech Republic achieving successful startup of the cell culture based influenza vaccine at the same time as implementing Lean Manufacturing; leading to a success rate from 40% to 95% within 22 months of inception.
With extensive knowledge of sterile production at Baxter’s facilities in Vienna, Christof brings a wealth of practical knowledge and experience in this field; and is a valuable and insightful member of the NSF Health Sciences team.
