Heidi Agostini, Ph.D., PMP
Co-Founder at Sequoia Consulting Group, a Maryland LLC- Claim this Profile
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Bio
Credentials
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PMP
Project Management InstituteJan, 2007- Sep, 2024
Experience
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Sequoia Consulting Group, a Maryland LLC
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Biotechnology Research
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1 - 100 Employee
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Co-Founder
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May 2023 - Present
Consultant assisting small and large companies in Tech Watch, white paper and full proposal development, negotiations, execution and program management assistance for HHS BARDA, NIH/NIAID and DOD programs. Consultant assisting small and large companies in Tech Watch, white paper and full proposal development, negotiations, execution and program management assistance for HHS BARDA, NIH/NIAID and DOD programs.
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EG Life Sciences
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United States
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Business Consulting and Services
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1 - 100 Employee
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Project Management Consultant
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2021 - 2023
Provide Sr. Program Management expertise to a growing diagnostics group within a pharmaceutical company. Develop MS Project & Smartsheet schedules, Risk/Mitigation tables, meeting minutes, program timelines, technical slide decks, develop contracts and manage vendors to meeting tight development timelines. Proficient in MS Teams, Zoom, Word, Excel, PowerPoint, Mural, SharePoint, BOX, MS Project and Smartsheet. Provide Sr. Program Management expertise to a growing diagnostics group within a pharmaceutical company. Develop MS Project & Smartsheet schedules, Risk/Mitigation tables, meeting minutes, program timelines, technical slide decks, develop contracts and manage vendors to meeting tight development timelines. Proficient in MS Teams, Zoom, Word, Excel, PowerPoint, Mural, SharePoint, BOX, MS Project and Smartsheet.
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Co-Founder
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2017 - 2021
• Developed multiple large proposals for various companies for submission to HHS BARDA, NIH/NIAID and DOD resulting in contract awards >$200M. • Executed US Government contract development including Tech Watch, white paper and full proposal development, negotiation, execution, and program management assistance for multiple small and large US government contracts. • Developed multiple large proposals for various companies for submission to HHS BARDA, NIH/NIAID and DOD resulting in contract awards >$200M. • Executed US Government contract development including Tech Watch, white paper and full proposal development, negotiation, execution, and program management assistance for multiple small and large US government contracts.
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Leidos Biomedical Research Inc.
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United States
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Research Services
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200 - 300 Employee
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Clinical Research Financial Director
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2017 - 2018
• Developed detailed clinical trial budgets for NIAID funded trials for Ebola, HIV, Schistosomiasis and Emerging Infectious Diseases in Mali, Liberia, and Indonesia that led to successful completion within cost and schedule. • Executed process improvement methodologies by developing financial templates for use with NIAID sponsored clinical programs. • Coached clinical financial and programmatic staff in best practices in development and use of clinical operations budget templates. • Developed detailed clinical trial budgets for NIAID funded trials for Ebola, HIV, Schistosomiasis and Emerging Infectious Diseases in Mali, Liberia, and Indonesia that led to successful completion within cost and schedule. • Executed process improvement methodologies by developing financial templates for use with NIAID sponsored clinical programs. • Coached clinical financial and programmatic staff in best practices in development and use of clinical operations budget templates.
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Director, Govt Project Management, Partnering and Strategy Group
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Aug 2010 - 2017
• Led a team of six FTEs in developing, negotiating, and successfully managing multiple, large government funded drug development programs ranging from $10M-$7.6 Billion delivering complex/high business impact drug development projects within cost and schedule. • Served as the main point of contact with US government officials from BARDA, DOD and NIAID for both MedImmune and AstraZeneca programs. • Served as NIAID Small Business grant reviewer focusing on funding requests for development of vaccines, therapeutics, manufacturing and scale-up activities and development of medical devices. Show less
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Emergent BioSolutions
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United States
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Biotechnology Research
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700 & Above Employee
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Associate Director, Project Manager (Botulinum Vaccine and Therapeutic Programs)
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2007 - 2010
• Led the development of the Toxoid AB vaccine and recombinant Trivalent ABE vaccine programs including the management of program budgets, timelines and execution of strategic program plans. • Wrote and submitted numerous NIAID and BARDA grant proposals and was awarded a $1.8M NIAID U01 grant for the recombinant botulinum vaccine program. • Managed the acquisition and execution of contract award (AVP21D9 Anthrax mAb development program) for NIAID. • Led the development of the Toxoid AB vaccine and recombinant Trivalent ABE vaccine programs including the management of program budgets, timelines and execution of strategic program plans. • Wrote and submitted numerous NIAID and BARDA grant proposals and was awarded a $1.8M NIAID U01 grant for the recombinant botulinum vaccine program. • Managed the acquisition and execution of contract award (AVP21D9 Anthrax mAb development program) for NIAID.
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Senior Scientist (Recombinant Botulinum Vaccine Program)
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2004 - 2007
• Provided technical oversight and analysis of process development, manufacturing and process validation activities of subcontractors engaged in the development of Clostridium botulinum vaccine. • Developed SOWs, reviewed subcontractor’s proposals and reports, and wrote regulatory CMC sections regarding manufacturing and analytical methods for the Botulinum Toxin Vaccine Bulk Drug Substance (BDS). • Oversaw the development and execution of Validation Master Plans for Bulk Drug Substance (BDS). Show less
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Education
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Uniformed Services University of the Health Sciences
Ph.D., Pathology -
2015 - 2017
Stanford University Center for Professional Development
Advanced Project Management, Program Management -
Wright State University
M.S., Microbiology and Immunology -
Ohio Wesleyan University
B.A., Chemistry -
1991 - 1996
Uniformed Services University
Ph.D., Pathology/Experimental Pathology
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