Jared Schuster

About Jared Schuster

Regulatory scientist with strong laboratory background in immunology, oncology, infectious diseases and cell and gene therapies. Broad experiences within quality and regulatory affairs under FDA and international regulations (EMA, TGA, Health Canada, MHLW/PMDA, MHRA, PEI, MFDS).Hard skills-American Society of Clinical Pathology (ASCP) Certified Histotechnologist (HTL)-Phase-appropriate analytical development expertise for assay qualification and validation-Advanced understanding of research methodologies and clinical trial design -Technical writing expertise under CDMS requirements and GCP/GCLP-Excellent laboratory skills ranging from common techniques (Western blotting, qPCR, mammalian cell culture, plasmid prep, molecular cloning, ELISA, MSD) to more advanced techniques (IHC/IF/ISH, ex vivo tissue culture, multicolor flow cytometry, MALDI-TOF MS, NGS, ddPCR, antibody conjugation)-Extensive experience with histological techniques and digital pathology; advanced capabilities for quantitative image analysis across multiple digital image analysis platforms-Familiarity with: Prism Graphpad, Excel, ApE, R, Galaxy, FileMakerPro, GenomeStudio, eSlide Manager, ImageScope, ImageJ, Halo, Pathcore, Visiopharm, Adobe Photoshop-Expertise within GxP environments (cGMP, cGCLP, cGLP, cGTP), CLIA/CAP, and ISO-Donor screening and testing experience in compliance with 21 CFR 1271 & Dir. 2004/23/EC-Labelling expertise under ISBT 128 Standards and SEC requirements-FACT, AABB and WMDA Accreditation SupportSoft Skills-Substantial leadership experience with significant contributions to projects, presentations and materials within industry and academic institutions-Strong business acumen with considerable sales and marketing experience; track record of high-performance-Strong communications skills, including communication of complex scientific concepts and/or data to both scientific and non-scientific personnel alike-Demonstrated ability to thrive both independently as well as within collaborative environments -Outstanding customer service skills (over 12 years experience in customer-facing roles)-Dynamic thinker and innovative problem solver-Life-long learner with passion for education and personal developmentOpinions expressed on LinkedIn are my own and do not necessarily reflect the opinions of my employer.

Experience

1. Regulatory Affairs Specialist

   NMDP

   May 2024 — Present · Minneapolis, MN, US

Education

• University of Minnesota

  Bachelor's Degree, Molecular Genetics (B.S.)

  2009 — 2013

• University of Minnesota

  Minor of Study, Pharmacology, Immunology Focus

  2009 — 2013

• Mayo Clinic School of Health Sciences

  Internship, Anatomic Pathology

  2008 — 2008

• John Marshall Senior High School

  H.S. Diploma, Science and Engineering Focus

• University of Minnesota

  Post-Baccalaureate Certificate, Biostatistics

  2016

• Mayo Clinic School of Health Sciences

  Internship in Anatomic Pathology, Clinical Research and Allied Professions

  2008 — 2008

Skills

• Project Management
• Statistics
• Event Management
• Histology
• Tissue Culture
• In Situ Hybridization
• Medical Diagnostics
• Western Blotting
• Clinical Trials
• Third Party Vendor Management
• Microsoft Office
• Public Speaking
• Contract Negotiation
• Antibodies
• Social Media
• Pharmacology
• Cell Culture
• Molecular Biology
• Fluorescence Microscopy
• Illustrator
• Marketing
• Adobe Creative Suite
• Immunofluorescence
• Research
• Reverse Transcription Polymerase Chain Reaction (Rt-Pcr)
• Customer Service
• Immunohistochemistry
• Laboratory Skills
• Pcr
• Biomarkers
• Data Analysis
• Medical Devices
• Clinical Research
• Immunology
• Assay Development
• Gel Electrophoresis
• Biology
• Photoshop
• Immunoassays
• Dna