Experience
September 2023 - present
NorthStar Bioprocess Consulting LLC
Provide high-value consulting services in the CMC area, particularly for process development and manufacturing of early- and late-stage biopharmaceutical products (monoclonal antibodies, recombinant proteins, antibody-drug conjugates, gene therapy).
2013 - 2023
Takeda Pharmaceuticals
Provided operational and strategic support for the Biotherapeutics Process Development Department. Led upstream and downstream DS process development activities (including in-process analytical support) for biotherapeutic pipeline (antibodies, highly engineered proteins, recombinant proteins, bioconjugates, gene and cell therapies, and live bacterial therapeutics).
NorthStar Bioprocess Consulting LLC was founded by Dr. Norbert Schuelke. He is a results-driven leader with a strong academic background and with over 25 years of experience in the development and manufacture of monoclonal antibodies, complex recombinant proteins, antibody-drug conjugates, and gene therapy products. He has extensive CMC experience with all stages of product development, including commercialization. Dr. Schuelke has authored over 20 scientific papers and is a co-inventor on multiple patents.
2005 - 2013
Millennium Pharmaceuticals, Inc.
Downstream Process Development Group Leader at Millennium and oversaw manufacturability assessment, process development, characterization, and process performance qualification (PPQ) activities for the downstream manufacturing processes for Biologics
1998 - 2004
Progenics Pharmaceuticals, Inc.
Group Lead of the Protein Biochemistry Group and worked on multiple research projects for HIV vaccines, HIV therapeutics, prostate cancer vaccines, and prostate cancer therapeutics.
Academic Background
1996 - 1998
University of Pennsylvania
Research Assistant Professor conducting research in the field of protein import into mitochondria. Served as an instructor for Cell Biology classes at graduate student level
1989 - 1995
Rockefeller University
Post-doctoral fellow conducting research in the field of protein transport across membranes
Education