Susan Haupt

Coordination of daily lab operations to ensure compliance with regulations and industry standards (including FDA, ICH, EMA, ISO, GMP) and supervising personnel. Subject Matter Expert in microbiological and analytical methods. Head method transfers, qualifications, validations and supervise method troubleshooting. Representing the lab in all matters of QC.

Experienced in analytical method development, transfer, and validation for (bio)-pharmaceuticals and cannabis testing, ensuring compliance with ICH guidelines according to GMPs. Microbiological and chemical analysis of raw materials, APIs, and finished products using compendial methods (USP, EP). Proficient in HPLC, LCMS, GCMS, ICPMS, Agilent ChemStation & MassHunter, stability studies & environmental monitoring, sterility testing (clean room), endotoxin, TOC, bioburden, and microbial enumeration.

Conducted analytical testing, both routine and non-routine, for industries including food, pharmaceuticals, cannabis, and natural health products. Operated in a cGMP certified analytical laboratory with ISO 17025 accreditation, adhering to pharmacopeias (USP, EP, JP). Demonstrated proficiency in various analytical techniques: HPLC-UV, HPLC-RID, LC-MS/MS, TLC, and bench chemistry tests. Contributed to method enhancement and development and improvement of Standard Operating Procedures (SOPs).

Contributed to research projects applying chemical & biological systems for catalytic conversion of agricultural products to platform chemicals. Supervised & mentored students. 1 Genetically engineered yeast to produce Bacteriocin during bioethanol fermentation. Proficient in Sanger DNA sequencing, plasmid purification, transformation, PCR, fermentation (5L & 10L bioreactors). 2 Supported biomass conversion projects, utilizing skills in HPLC-RID, HPLC-DAD, GCMS, GC-FID, FTIR, spectroscopy, pyrolysis.

Conducted thesis research at the Department of Diagnostics, Unit Nanotechnology. Developed a 3D-printed microchip for early detection of peptide epitope-specific antibodies in blood serum ("ImmunoChip"). Proficient in immunoassays, rapid prototyping, microfluidics, lateral flow assays, nanoparticles, point-of-care testing (POCT), lab-on-a-chip systems, and AutoCAD. Under Dr. Dirk Kuhlmeier - Head of MicroDiagnostics Unit

Contributed to startup services and technology transfer projects (EU-Projects ‘Go-Bio ELiSTA’ and 'BioKreaT') in Life Sciences. Skills include market/patent/technology research, market & gap analysis, project evaluation, project appraisal, and regulatory compliance (ISO 13485).