Copenhagen, Capital Region of Denmark, Denmark
- 20+ years of experience with producing antibodies (and antibody mixtures) in bio-pharmaceuticals projects - 30+ years of experience with cell culture (mammalian, yeast, filamentous fungi) - Proven abilities to successfully lead pre-clinical stage upstream process development of bio-pharmaceutical projects - Proven abilities to drive clinical stage cGMP antibody manufacturing processes to meet quantity/quality demands, regulatory approval, and timelines: => Project has been successfully taken from preclinic to phase 2 and out-licenced to major pharma company. => Projects has successfully been taken through process characterization, PPQ-batches and to commercial phase and approval. - 30+ years of experience with CMO and CRO's with responsibility for cGMP cell bank manufacture, cell line biosafety programs, upstream processes from thaw to harvest in both pre-clinical and clinical stage antibody projects. - Responsible for upstream sections for FDA and EMA for document packages and have participated in FDA meetings (also in Silver Springs, WA) - Developing concepts for production of antibody mixtures: 2 patents in manufacturing technology
Key responsibilities: Directing the upstream process development team (4 persons+): • Acquiring, negotiating and implementing upstream technologies (single-use systems, analytical equipment etc.) • Determine process conditions/criteria and develop procedures for tech transfer and scale-up of upstream process. • Methodologies: Classical process optimization, Design of Experiments, Quality by Design, Risk analysis • Leading tech transfer of upstream process to CMOs (from vial thaw to harvest) in several projects • Responsible for raw materials, timelines, contractual details related to upstream activities and process troubleshooting at CMOs Develop concepts and optimize upstream process for production of antibody mixtures
Post. Doc. position in Nanobiosensors in DNA repair and anti-cancer drug screening.
DNA Repair in yeast DTU PI: Uffe H. Mortensen