Consultant, Pharmaceutical Services

Phone: +44(0)1751 432999
Country: Austria

Christof Langer is a recognized expert in the quality assurance of recombinant APIs manufacture as well as sterile products including biologicals, vaccines and early-phase formulations. He possesses a wealth of practical knowledge and experience in this field, from delivering inspection readiness across a range of organizations to acting as an accomplished GMP auditor.

Mr. Langer has 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 and QA guidance for manufacturing at routine and clinical stages
  • Consulting for build, roll-out and management of API and biologics manufacturing sites

As Managing Director of Baxter Bioscience sàrl in Switzerland, responsible for supply of a unique recombinant Factor VIII formulation, Mr. Langer managed a team of 500+ and had a budget responsibility of $80m pa. Driving a culture of continuous improvement and utilizing critical path analysis, his team ensured order fulfillment reaching 100 percent on time in full. He also led a $10m capital investment program to improve plant capacity and achieved six keynote regulatory inspections without adverse observations.

Earlier in his career, Mr. Langer was Managing Director at Baxter s.r.o. in the Czech Republic. He achieved successful startup of the cell culture-based influenza vaccine and implemented Lean manufacturing practices that increased the success rate from 40 percent to 95 percent within 22 months of inception.

With extensive knowledge of plasma derivatives production at Baxter’s facilities in Vienna, he also brings a wealth of practical knowledge and experience in this field.