SFL is a leading consultancy providing integrated solutions to pharma, biotech and medtech companies for all product life cycle stages: Regulatory Affairs & Regulatory Intelligence, Quality & Supply Chain, Medical Writing, Public Affairs & Market Access, Pharmacovigilance, and Healthcare Compliance. In addition, SFL can act as marketing authorization applicant and MAH in Switzerland and the EU and conduct submissions to FDA, PMDA and Health Canada and other authorities.• Cross-functional expertise: worked closely with the Regulatory Affairs and Market Access teams to provide tailored support for product development and lifecycle processes across various therapeutic areas and product classes, including pharmaceuticals, biotech, and medtech products.• Regulatory writing: prepared detailed regulatory documents such as briefing books, Orphan Drug Designation (ODD), Risk Management Plans (RMP), Pediatric Investigation Plans (PIP), and Common Technical Document (CTD) dossiers.• Management of Key Opinion Leader (KOL) and Subject Matter Expert (SME) engagement projects: transformed complex scientific information into compelling content for medical communication projects and scientific events.• Medical communication: developed a wide range of materials including publications, abstracts, posters, slide decks, brochures, and educational content.• Tailored communications: created engaging and effective communications for various stakeholders, including regulators, payors, healthcare professionals, and patients.• Transformation of complex scientific information: synthesized intricate scientific data into clear, compelling content for medical communication projects and scientific events.• Evidence-based review: performed thorough scientific reviews and analyses to ensure data and documents were accurate, up-to-date, and met project requirements.

PPD, a Part of Thermo Fischer Scientific, is a leading global contract research organization (CRO) focused on delivering life-changing therapies. As part of Thermo Fisher’s Clinical Research Group, PPD offers comprehensive lab services, including a Bioanalytical Lab that has helped bring thousands of compounds to market by employing 1500+ validated methods.• Oversaw 42 projects (22 total client contracts) for ELISA-based pharmacokinetic and anti-drug antibody analysis of pharmaceutical compounds in patient serum, plasma, or blood (Phase I-III clinical trials for indications spanning various cancers and neurodegenerative diseases).• Drafted and designed sample analysis study protocols and bioanalytical plans.• Communicated with clients regarding deadlines for project deliverables including status updates, final study reports, and assay performance.• Facilitated method validation, optimization, and technical troubleshooting.• Organized, scheduled, and supervised laboratory scientists (4 direct reports) and laboratory resources for group's project activities.• Reviewed, interpreted and analyzed data for technical quality and compliance to protocols, methods and SOPs; reviewed laboratory investigations and deviations.• Responded to client questions and needs, coordinated client communication and recorded meeting minutes.• Assisted group leaders and associate group leaders in their responsibilities.

• Directed complex ELISA-based assays to measure clinical pharmaceutical compounds (including monoclonal antibodies, antibody-drug conjugates, anti-drug antibodies, recombinant proteins, and vaccines) in patient serum.• Provided technical and scientific knowledge to team members in immunochemistry-based bioanalytical methods.• Supervised the scientific conduct of projects and communicated regulatory issues with senior level team members.

My graduate research investigated how natural killer cells sense murine cytomegalovirus-infected targets and elucidated a novel and vital role for natural killer cell inhibitory receptors in protection from viral disease.• Successfully managed four scientific projects demonstrating collaboration and team leadership skills culminating in publication of three first-author articles.• Demonstrated unique presentation skills at regional and international scientific conferences, symposia, and meetings evidenced by multiple oral presentation selections and trainee awards.• Effectively communicated area-specific scientific expertise to academic thought leaders by designing and delivering departmental seminars and lectures (3-4/year).• Developed deep understanding of antiviral immunity and viral pathologies, which informed evaluation of biomarkers on responding natural killer cells, diagnosis of viral infection severity, and treatment efficacy. • Established a peer network and facilitated teamwork environment by mentoring and tutoring 10 undergraduate, 7 graduate, and 2 post-doctoral students to facilitate accomplishing their goals.• Developed strong and productive relationships with lentiviral transduction and CRISPR/Cas9 gene-editing experts internally and at external institutions that facilitated technology transfer and resulted in 2 collaborative, peer-reviewed publications in top scientific journals.• Attended and presented at bi-weekly journal clubs to find, analyze, and interpret the newest and most cutting-edge publications and to summarize their findings effectively and succinctly.• Planned, designed, and authored 2 highly competitive pre-doctoral scientific grants for the National Institutes of Health (NIH) and the Wagner Fellowship from the University of Virginia.• Proved exceptional initiative and leadership by facilitating seminars from visiting faculty members as leader of the Immunology Center’s Student-invited Speaker Committee.

• Developed expertise in CRISPR/Cas9 gene-editing and tumor cell culture by engineering CRISPR/Cas9 plasmid constructs to ablate genes in Lewis Lung Carcinoma (LLC) cells.• Showed ability to see a project through to completion by transfecting LLC cells with CRISPR constructs and confirming gene-editing via high resolution melting (HRM) qPCR and flow cytometry.• Designed an ex vivo assay for analysis of cytokine-activated of human lymphocytes using intracellular staining and flow cytometry.

• Initiated and facilitated strong and productive relationships with internal CRISPR/Cas9 gene-editing experts that enabled technology transfer and ultimately resulted in generation of a novel knockout mouse model and multiple peer-reviewed publications.• Designed and constructed CRISPR/Cas9 gene-targeting constructs, established a precise gene-specific PCR screening strategy for detecting mutations, and discovered successful gene-editing following transfection of mouse embryonic stem cells with the CRISPR constructs.• Proved extraordinary scientific acumen, productivity, and presentation ability by delivering oral presentation undergraduate thesis, resulting in multiple awards.

• Acquired proficiency in protein biochemistry by implementing site-directed mutagenesis to mutate the active site of an aminotransferase from Thermatoga maritima bacteria.• Explored theoretical impacts of active site mutation using PyMOL visualization software.• Led, executed, and evaluated kinetic assays with wild-type and mutant enzymes to determine the effects of single amino acid changes on catalysis.• Conceptualized and constructed poster presentation summarizing results.

• Accumulated experience in fundamental molecular biology techniques such as primer design, genomic DNA isolation, high-resolution melting qPCR, DNA gel electrophoresis, plasmid propagation and transformation, plasmid DNA isolation, and DNA sequencing.