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

Senior Associate/Sterility Assurance Expert consultant at JYA.

Responsible for sterility assurance/microbial control programs across Resilience CDMO global site locations. Leads team that provides oversight to sterility assurance/microbial control to manufacturing operations to ensure production processes are designed and executed with appropriate contamination controls. Creates sterility assurance, contamination control strategy and viral safety global standards to ensure alignment and best practices across sites. Leads Microbiology, Contamination Control and Aseptic Processing Communities of Practices (CoPs).

Accountable for developing and overseeing the implementation of robust and comprehensive microbial contamination control and viral safety programs at Resilience. Responsible for collaborating with multiple stakeholders to ensure the harmonized execution of contamination control policies across the Resilience network. Responsible for supporting new product transfers related to contamination control aspects of manufacturing process and equipment design, microbial method validations and rapid microbial methods. Establishment of EM Program and microbial risk control strategy for Resilience network. Working remote from Las Vegas, Nevada.

Head of Global Microbiology Management leading the Global Micro Takeda team and supporting Takeda's worldwide manufacturing facilities. Will relocate to MA post COVID. Remote from CA and NV currently. Continue to support Thousand Oaks during transition of my previous role.

Accomplished industry leader in pharmaceutical Microbiology. Responsible for harmonization of Microbiology at bbb internal and external manufacturing facilities.

With over 20 years of Pharmaceutical and Medical Device industry experience in Microbiology and Quality, I provide premier consulting services as a Senior Consultant with Concordia. My expertise is in Microbiology, Sterilization, Packaging and ISO 13485 auditing (former notified body auditor). Cleanrooms, Water Systems, Environmental Monitoring Programs, Microbial Testing, Sterilization Validations, Process Validations, Risk Analysis and ISO standards/auditingPDA Scientific Advisory Board (SAB) memberAAMI ISO 14160 voting committee memberISO 13485 Lead Auditor

Responsible for Corporate Quality Control (Lab Services) including Raw Material Testing, Product Testing, Specifications, Lab Investigations and QC Training as well as Corporate Microbiology. Responsible for alignment and best practices of these QC functions across the Dendreon manufacturing facilities. Setting Corporate QC & Microbiology policies and procedures. Responsible for ROW Microbiology activities.

Responsible for alignment and best practices of Microbiology across the Dendreon manufacturing facilities. Responsible for Microbiology for ROW.

Accountable for providing leadership, management and delivery of compliant microbial laboratory data in support of Dendreon’s products and in accordance with appropriate regulatory, corporate and scientific guidelines. Manages the Microbiology Laboratory operations on a daily basis, as well as during inspections/audits by the FDA and other regulatory agencies. Functions in a fast-paced, highly technical environment, and communicates effectively. Leads, develops and mentors reporting staff at a variety of levels. Works as a partner with Manufacturing to support facility start-up, validation and production needs.

Director of Quality for a start-up CMO in Irvine, CA. Responsible for quality at Avrio including internal and external audits, CAPAs, the Quality Management System, hosting Management Review Meetings and supporting clients.

Responsible for performing ISO 9001:2000, ISO 9001:2008, ISO 9001:13485 Quality Management System assessments as well as CE and CMDCAS assessments for medical device manufacturers in the USA.- ISO Lead Auditor Certified- MDD/CE Certified- CMDCAS CertifiedMicrobiology Product Expert responsible for microbiology/sterilization/packaging/contamination control ISO assessments for medical device manufacturers of sterile devices- Responsible for performing ISO 13485 and MDD/CE audits specializing in Microbiology - Responsible for performing dossier reviews for CE applications

Head of Global Microbiology working in Quality Assurance for an eye care manufacturer -Responsible for harmonization of Microbiology policies and procedures at the AMO worldwide manufacturing facilities (China, Spain, Sweden, Netherlands, Puerto Rico & CA) and providing technical guidance and leadership to the sites- In this job was a contributor to new product development including all design phases, design reviews, risk analysis including FMEAs, IQ/OQ/PQs, new product launches as well as continued quality oversight for day to day manufacturing process as well as sterilization processes for all marketed products at all worldwide manufacturing facilities. Aseptic processing, EtO, Gamma, E-beam and steam sterilization all performed.

Worked as the Microbiology manager at GPSG Vacaville, Project Manager and Senior Sterilization Scientist for Depuy Spine in Raynham, MA.