Heather Lapp Noucas Email & Phone Number

- Manage microbiology group of two scientists and five Research Associates in bacterial growth development, sample preparation, and completion of controlled documentation- Work in a cross-functional team of science, engineering, QA, and regulatory to coordinate verification and validation activities- Organize Microbiology R&D activities for developmental projects to meet project milestones according to timeline for government contracts- Collaborate with cross-functional teams in R&D and Operations to produce commercial products under GMP methods- Author quality controlled documents including SOPs, work instructions, protocols, manufacturing production records, and reports to support development, verification, and commercialization of T2 Biosystems products- Optimize and validate cultivation methods for clinically-relevant bacterial and fungal species to facilitate development and verification of in vitro diagnostic assays- Manage Microbiology team efforts for the production of contrived patient samples for the verification of four in vitro diagnostic panels for FDA 510(k) submission- Established, developed, and optimized virology and mammalian cell processes for development and verification of the T2SARS-CoV-2 Panel and T2SARS-CoV-2 quality control samples- Present data to multiple internal groups, including senior management and commercial, and interacted with multiple levels of management for deciding business priorities - Coordinated BSL-3 activities for two CRO laboratories for development of T2Biothreat® Panel- Led optimization efforts for manufacturing process of T2 Biosystems quality control samples and transferred methods to control manufacturing- Presented data at international scientific conferences

Lexington, Massachusetts

Lexington, Ma

• Optimized microbial cultivation methods and processes during development of the T2Bacteria® Panel• Developed, refined, and executed batch records, SOPs and work instructions• Developed microbiological methods for titer level assignment and sample production to support assay development• Developed, established, and executed processes for preparation of samples to support assay verification and validation activities• Prepared contrived samples and completed documentation to support T2Bacteria® Panel FDA and CE submissions

Lexington, Massachusetts

• Conducted in vitro microbial adherence assays to assess non-fouling surface modifications• Developed, optimized, and performed mammalian cell culture assays, including cell activation assays and ELISAs• Ran radioactive protein adherence assays and deliver results as needed• Attended and helped manage in vivo testing• Analyzed and presented data

• Researched cholesterol metabolism of Mycobacterium tuberculosis by generating genetic mutants unable to utilize cholesterol, examining the effects of statins on eukaryotic host cells and M. tuberculosis during infection, and using carbon-13 to label, extract, and monitor macrophage sterols with gas chromatography-mass spectrometry• Full-time students’ representative on the Board of Studies• President of the Cheerleading Club 2013-14 which managed 72 students and coordinated with the University and Students’ Union; Club Colours Award Recipient for outstanding contribution to a sports club• Annual Fund Grant award recipient 2014

Cambridge, Ma

• Developed and ran biofilm assays to assess non-fouling surface modifications• Analyzed data and presented in group meetings as well as data preparation for conference posters; created and organized biofilm data • Wrote technical reports, new standard test method procedures, and work instruction documents

• Performed microbiology tests according to AAMI, USP and ISO guidelines in a GMP/GLP setting, including Bacterial Endotoxin LAL, bioburden testing, sterility testing, microbial challenge and antimicrobial assays• Maintained microbial cultures safely for their growth promotion and disposal, as well as microbial identification

• Processed student group affairs including purchase orders, invoice payments and check distributions• Balanced weekly incoming ticket sales via cash, credit card and Boston University points• Reorganized office and student manuals to maximize space, efficiency and procedure

• Improved laboratory organization and cleanliness• Provided assistance in various experiments, including solution preparations and autoclaving as well as slide cover-slipping• Reorganized scientific journal filing and provided copies of requested articles

• Coordinated 212-room hotel on sold out nights during special events• Managed guest reservations and payments

Master Of Science (Msc), Medical Microbiology, Distinction

Activities and Societies: Competitive Cheerleading Team 2012-14 (Captain 2013-14), Club Colours Award for Outstanding Contribution.

Graduate Certificate, Epidemiology

B.A., Biology

Activities and Societies: BU Bowling Association (Secretary); BU Community Service Center: Project Hope (Peer Leader), Student Food.

High School Diploma

Activities and Societies: Varsity Cheerleading Captain, Philharmonic Orchestra Co-Vice President, Senior Class, National Honor Society.