Project Manager Quality Assurance

Leonardo Tavormina

Phone 310-***-**** Address ***1, E. Ocean Blvd. Long Beach, CA

Email ************@***.*** Linkedin linkedin.com/leonardojames EDUCATION

Keck Graduate Institute (KGI) GPA: 3.67

Master of Engineering in Biopharmaceutical Processing Expected Graduation May 2025 Relevant Coursework: Biopharmaceutical Quality Assurance and Control, Fundamental Papers of Biotechnology, Upstream Processing Laboratory, Downstream Processing Laboratory, Team Master's Project, Team Design Project California State Polytechnic University, Pomona

Bachelor of Science in General Biology May 2023

EXPERIENCE

Project Manager for Team Design Master's Capstone Project (KGI)August 2024 - present

● Led a team that designed a theoretical biotechnology company that manufactures an allogeneic CAR T-cell therapy based on a real product from Kite with in-depth consideration for bioengineering process flow diagram for multiple cell lines, facility design, quality by design, process validation, change control, economics, and other logistical considerations.

● Presented theoretical allogeneic CAR T-cell therapy process flow diagram to university faculty, alumni and other masters students.

Co-author for Regulatory Intelligence Literature Review August 2024 - present

● Conducting the first of its kind, in-depth literature review on regulatory intelligence. Collaborating with three graduate students and the principal investigator (PI) to research, collect, and analyze the importance of regulatory intelligence in the pharmaceutical industry.

● Engaging in weekly discussions to refine key topics, align writing strategies, and synthesize complex regulatory concepts.

● Assessing and selecting an optimal research journal for publication based on relevance, impact factor, and target readership.

Quality Control (QC) Microbiology Intern at Regeneron June 2024 - August 2024

● Helped design and justify to Regeneron team a collaborative growth promotion study using Geobacillus stearothermophilus to ensure that TSB and TSA growth media meet regulatory and company standards

● Engaged in ISO 8 gowning technique training with qualified Regeneron staff trainer

● Extensively discussed regulatory auditing, both external and internal, with Regeneron managers and directors

● Learned fundamental principles of biological indicator (BI) testing, growth promotion (GP) testing, and sterility testing in GMP laboratories and facilities

Graduate Student Consultant for Pfizer (KGI Team Master's Project) September 2023 - May 2024

● Collaborated with Pfizer and teammates to utilize GoSilico simulation software to establish credibility for mechanistic modeling of late-stage downstream experiments.

● Established a procedure for assessing model credibility using a risk-based approach for a hydrophobic interaction chromatography (HIC) polishing step for a mAb-like molecule.

● Successfully applied GoSilico downstream model for process definition and characterization. Research Assistant at Cal Poly Pomona August 2020 - May 2022

● Participated in a diverse team to complete a large-scale plant genetics experiment in Dr. Sharma's lab

● Extracted and analyzed tissue data from plants grown directly in the lab to determine genetic sequence changes associated with different phenotypes

● Worked with other undergraduate students to ensure that experimental plants are properly maintained

● Engaged in group analysis with the professor on papers published by other prominent geneticists

● Received an ARI-HSI fellowship worth $6,400 to do research in this laboratory starting Fall 2021 SKILLS

● Laboratory & manufacturing skills, including microscopes, hemocytometers, gel electrophoresis, biosafety cabinet usage, CHO cell culture, upstream processing in benchtop bioreactor, and pipetting.

● Soft skills such as cross-functional teamwork, networking, project management, attention to detail, and team conflict resolution.

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