Kammie McHugh

About Kammie McHugh

Kammie is a Quality and Regulatory professional with two decades of proven experience in the biotechnology, pharma, and medical device industry. After receiving her BS in Biology, Kammie began her career in a clinical lab setting and later became an integral part of an R&D team that developed molecular assays from feasibility to FDA Clearance. After several years at the R&D bench, Kammie transitioned to a new role as Quality Systems Manager. Her growing interest in QA and regulatory compliance led her to the Masters of Science program in Regulatory Affairs of Drugs Biologics and Medical Devices at Northeastern University, from which she graduated cum laude in 2015. Kammie’s areas of expertise include contract manufacturing, scale up manufacturing, assay development, cGMP requirements, ISO 13485, ISO 9001, 21CFR820, EXCiPACT, biologics, medical devices, biotechnology, and quality system implementation and improvement. Kammie is practiced in active leadership while enforcing a strong Quality Management System to meet business needs in a rapidly evolving manufacturing and development environment. At LaunchWorks Manufacturing Lab, Kammie helped to steer a fast-paced and evolving Manufacturing environment into both ISO13485 certification an GMP compliance in under a year. Before LaunchWorks, Kammie worked at BioHelix, a subsidiary of Quidel, where she was the QA member of a team that received the highest award the company bestows for her achievement of development goals on a tight timeline. Thanks to her years of R&D experience, Kammie enjoys the technical and problem-solving aspects of supporting biotech projects with a Quality lens.Now at Boston BioProducts, Kammie is enjoying being a part of an executive team that is commited to compliance while still being able accelerate growth of labspace and offerings in a meaningful way. Kammie recently was part of a leadership team to construct and qualify a new ISO 5 and ISO 7 cleanroom laboratory at BBP. Currently Kammie is working on attaining ISO 9001/EXCiPACT certifications to add to the ISO 13485 certification at BBP

Experience

1. Director of Quality and Regulatory

   Boston BioProducts

   Oct 2023 — Present · Milford, MA, US

   Director of Quality and Regulatory at Boston BioProducts, a Contract Reagent Manufacturer for Life Sciences, Diagnostics, and Drug Development.

Education

• Northeastern University

  Master of Science (MS), Regulatory Affairs

  2013 — 2015

• Salem State University

  Bachelor of Science (B.S.), Biology, General

  2002 — 2006

Skills

• Qpcr
• Primer Screening
• Batch Records
• Multiplexing
• Infectious Diseases
• Plasmid Cloning
• Document Control
• Calibration Records
• Bacterial Cell Culture
• Sop Authoring
• Assay Optimization
• Iso 13485
• Assay Development
• Ma Hazardous Waste (Rcra) Training
• Vector Cloning
• Biotechnology
• Ivd
• Master Control
• Accurate Record Keeping
• Zenqms
• Lyophilization
• Medical Devices
• Flow Cytometry
• Multiplex Pcr
• Capa
• Gel Electrophoresis
• Equipment Management
• Biosafety
• Pcr
• Purchasing
• Internal Control Implementation
• Immunoassays
• Ln (Erp) System
• Sop
• Fda
• Elisa
• Molecular Cloning
• Environmental Monitoring
• Document Creation
• Employee Training