Marsha Steed

About Marsha Steed

Hello, I\'m Marsha Steed.Tired of working for corporate America, I decided to take a LEAP of faith in late 2023 and I opened my own Microbiology consulting company, Steed MicroBio LLC.Was I nervous? Yes!Was I driven by my passion to share my knowledge, experience and my obsession with teaching others about contamination control and good aseptic behaviors? Yes! Two years later, I could not be more thrilled with that decision. Some highlights so far:** I have grown my business to many clients and have expanded my team with people that share my passion for patient safety and love for Microbiology.(Be my next client!)** I teach an aseptic behaviors in isolators training course at SKAN US in Raleigh NC along with my business partners at SKAN. I chose SKAN as the location for my course so I could do hands on training inside of the isolators along with classroom content. My determination to teach people who are using isolator technology about good aseptic behaviors was \"MY WHY\" for creating the course. The course is a sell out each session and I\'d love to see you in my next course. Details in my website.** I had the HUGE honor of serving on the USP Microbiology Expert Committee Member (20••••25 Cycle) as a member and serving as leader of the Microbial Control and Sterility Assurance Sub Committee. There are no words to express how much that role meant to me. For me as a young microbiologist, I dreamed of what it must be like to write USP Microbiology chapters. Getting that experience was a career highlight. I tear up just thinking about that honor.** I give talks all over the world and love sharing my experiences with the industry. I hope to see you at one of my 2026 talks (see my website for my schedule).About my experience, I have over 30 years of experience in the pharmaceutical, biopharmaceutical, cell therapy/gene therapy and medical device industries with extensive experience in Quality and Microbiology. My leadership experience includes global experience with manufacturing locations in North and South America, Europe and Asia. I spent most of 2025 helping clients with FDA WL, 483 or global regulatory responses related to sterile processing.I have served on PDA for over 25 years including 10+ years as an Advisory Board member. There are two main ways I can help you:1. Microbiology consulting on anything micro, contamination control or sterility assurance.2. Training onsite, online or at my aseptic behaviors training course at SKAN.Check out more info on my website (link in my bio)

Experience

1. Founder and President

   Steed Microbio Llc

   Jan 2024 — Present · Henderson, NV, US

   Marsha Steed is a well known microbiology expert with over 30 years of experience in pharmaceutical, biotechnology and medical device companies. Marsha is a United States Pharmacopeia (USP) Microbiology Expert Committee (MEC) member and chair of the USP MEC Sterility Assurance and Microbial Control subcommittee. Marsha has been an active member of the Parenteral Drug Association (PDA) for over 25 years and currently serves on the Advanced Therapeutics Medicinal Products (ATMP) Advisory Board and is a former member of the Scientific Advisory Board (SAB) and the Educational Advisory Board (EAB). Marsha has lead PDA Technical Report (TR) teams, contributed to TR content and served as chair and member of multiple PDA industry conferences and events. Marsha has a passion for microbiology and loves consulting, mentoring, and educating industry on anything and everything Microbiology!Steed MicroBio, LLC offers microbiology consulting and training expertise with a focus on sterility assurance. Marsha offers consulting and education services to meet your compliance needs. Custom microbiology/sterility assurance training can be created to meet your needs. Consulting focus areas include:Contamination Control Strategy (CCS) DevelopmentAnnex 1 Compliance SupportMicrobial Risk Assessment FacilitationMicrobial Data Deviation (MDD) Investigation SupportDevelopment of Environmental Monitoring (EM) ProgramsEM Risk Assessment FacilitationFacility Design Review/SupportMicrobial Testing SupportAseptic Process Simulation (APS) supportFailed APS Investigation SupportAuditingCDMO oversight support

Education

• Western New England University

  BS

  1990 — 1993