Amber Sandness

About Amber Sandness

I am a pharmaceutical manufacturing leader with 9+ years of experience in aseptic drug product manufacturing, sterile injectables, QC microbiology, environmental control, and cross-functional GMP operations. My background spans both large-scale and fast-paced startup environments, supporting end-to-end production of parenteral drug products from formulation and fill-finish through release-enabling testing and documentation governance.I specialize in building and leading high-performing teams, managing CMOs, and driving the operational excellence needed to reliably supply clinical programs. Throughout my career, I’ve strengthened sterile manufacturing readiness, optimized workflows, and delivered measurable improvements in quality, compliance, and efficiency — including a 20% reduction in cycle times, a 60% increase in audit readiness, and the elimination of long-standing documentation backlogs.My passion lies in bridging technical manufacturing, quality systems, and program execution to enable safe, compliant, and uninterrupted supply of critical medicines. I have deep experience collaborating with Manufacturing, QA/QC, Program Management, Engineering, Materials Management, Formulation Development, and Regulatory Affairs to solve complex problems and keep programs on track.What I bring to drug product leadership roles:• Aseptic processing + sterile injectables expertise• Understanding of formulation, filtration, sterilization & lyophilization workflows• Strong background in GMP utilities, equipment, and facility readiness• Proven ability to manage CMOs and contract partners• Root cause analysis, risk mitigation & continuous improvement mindset• Technical team leadership, training program development & talent growth• Excellence in documentation, batch records, SOPs, and regulatory complianceI am motivated by work that directly impacts patient access — especially in innovative modalities such as nucleic acids, biologics, and next-generation parenteral therapies. I thrive in environments where science, quality, and operations intersect, and where leadership drives both execution and long-term capability building.If you’re working in drug product development, manufacturing science & technology, or clinical supply operations, I’d love to connect.

Experience

1. Qc Manager

   Osypka Medtec Inc

   Jan 2026 — Present · Longmont, CO, US

Education

• Metropolitan State University of Denver

  Bachelor's degree

  2015 — 2016

• Arapahoe Community College

  Associate of Science (AS)

  2011 — 2013