Dr. Stefan Haider

Medical & Pharmaceutical Biotechnology -Downstream Processing -Pharmaceutical Protein Production Systems

Responsible for the development, scale-up and transfer of biopharmaceutical production processes for BI's NBEs as well as for client projects to clinical and commercial scale facilities. Leading & coaching matrix leaders in DS process development (focus USP development). Coordination of the project portfolio in upstream development for NBE &client projects including management of allocated resources. Continuous improvement of the groups capabilities by introducing new technologies and new ways of working.

Responsible for the development, scale-up and transfer of biopharmaceutical production processes for BI's NBE & biosimilar projects to clinical and commercial scale facilities. Lab head of a microbial upstream development group consisting of scientific and technical staff. Coordination of lab work as well as NBE & Biosimilar project portfolio in upstream development. Business project manager & SC member for the deployment and implementation of the InCyght fermentation data analysis software (PAS-X Savvy).

Biopharmaceuticals / Process Science - Downstream Development I Downstream development of NBEs and biosimilars at bench scale, support of up-scaling and facility fitting. Team member in cross-project panels, continuous improvement initiatives and technology development platforms. Principal investigator in joint research projects with the Austrian Center for Industrial Biotechnology.

Biologics R&D / Drug Development - Protein Modification Coordination of development activities in late-stage projects and lead of a small R&D team focusing on product- and process-related analytics.

Global Biologics Research / Drug Development - Protein Modification Shift of responsibilities from early developments to late stage product development to support transitioning the drug candidates into clinical testing and ultimately to operations (longer-acting ADVATE® follow-ups). Key focuses: Trouble shootings and root cause analyses of critical process steps. Facilitation and coordination of QbD projects and studies.

Hemophilia, Exploratory & Preclinical R&D - Protein Modification Development of novel strategies for the chemical modification of blood coagulation factors (FIX, FVIII, FVIIa) with polymeric substances. Responsibility for reaction design and optimization, establishment of suitable preparative purification techniques for the drug candidates as well as for the product- and process-related analytics.

Institute of Medical & Pharmaceutical Biotechnology Supervising and supporting students in the bioprocess technology lab.

Biopharmaceutical Operations / Process Science - Downstream Responsible for the development of a generic process for the epsilon-amino-PEGylation of therapeutic peptides. Key focuses: a) the investigation of the conjugation reaction by applying principles of DoE in order to obtain a mechanistic view of the reaction progress; b) the development of chromatographic purification techniques for the resulting conjugates; and c) the analytical characterization of the conjugates.

Chemical Engineering / Dissertation: "N-Glycan Modification of Recombinant Factor IX - A Novel Approach for the Polysialylation of Therapeutic Proteins"

Diploma thesis: "Characterization of monoPEGylated alpha-Lactalbumin"