CHRISTEN LIBERTINY, M.SC., PMP

201-***-**** ad37k3@r.postjobfree.com Mahwah, NJ 07430

SUMMARY

An experienced scientist with over 15 years in the pharmaceutical industry with a strong track record in research, project management, and regulatory documentation. Committed to advancing innovative medicines and treatments, adept at multitasking and problem-solving in fast- paced environments. Known for integrating novel technologies, communication, resourcefulness, adaptability and driven by a dedication to significantly impacting healthcare through continuous education and motivated by the prospect of improving patients' lives and contributing to groundbreaking therapies.

SKILLS

WORK HISTORY

REGENERON PHARMACEUTICALS

Tarrytown, NY

Scientist 2009 to 2023

• Led the development, optimization, and utilization of state-of-the-art technologies, including AlphaLISA, MirrorBall, Flow Cytometry, and SPARCL which led to a 20% improvement in assay sensitivity

• Developed Cross-Competition assays, harnessing biotinylated antibodies on virus-like Particle surfaces. Disseminated research findings through impactful publications, presentations, and conferences

• Played a key role in rapid response teams addressing emerging diseases like SARS-CoV2, Ebola, and MERS in collaboration with BARDA and NIAID resulting in a reduction in response time during critical outbreaks

• Developed, optimized, and applied flow cytometry technology in the challenging landscape of infectious disease and immune-oncology

• Generated comprehensive data and regulatory submission documentation reports to support IP, IB, Opt-In, IPA, and IND filings, empowering legal and regulatory processes for crucial targets while increasing the number of successful filings by 18% year over year

• Integral contributor to filings for diverse disease states, including but not limited to SARS-CoV2, Ebola, MERS, Zika, CD20, CD40, PD1, PDL-L1, CD3, MUC16, FelD1, PCSK9, GFRa3, LEPR, IL-4R, IL-33, IL2Rg, LAG3, TMPRSS6, and BETv1.

• Authored and reviewed regulatory submission packages for IP, IB, Opt-In, IPA, and IND filings with the FDA. Evaluated support documentation for FDA and responded to questions from regulatory bodies

• Crafted compelling presentations for higher-level meetings, fostering meaningful discussions and collaboration

• Developed and implemented project timelines, prioritized tasks for sub-teams, and ensured timely and successful project completion

• Integral liaison between focus area groups and research to ensure target dossiers are complete and priorities aligned while developing and implementing protocols to move targets from R&D toward FDA approval at an accelerated rate

• Demonstrated project management skills, consistently meeting pertinent milestones while juggling multiple high-priority projects and maintaining project timelines and quality

• Maintained the highest standards of regulatory write-up submission as IP Auditor, ensuring compliance with internal and external regulations in addition to reducing total filing time by 20%

• Thrived in high-pressure and ever-changing environments, ensuring timely and successful project completion with minimal supervision

• Managed laboratory personnel, ensuring top-notch work quality, and providing mentorship, training, and guidance to newly hired employees and interns Senior R&D Specialist/R&D Specialist

• Spearheaded development of secondary assays and analysis, employing functional ELISAs and cell-based methods for antibody identification and classification

• Applied expertise to diverse areas like Infectious Disease, Pain, Skeletal Diseases, Immuno-Oncology, and HLA-PIGs, advancing understanding of these fields and driving drug development

• Developed antigen binding interactions assays with cell surface, Virus-Like Particles, and nanoparticles, using ELISA, MSD, and flow cytometry technologies increasing sensitivity

• Pioneered cutting-edge target and cross-reaction screening of antibody supernatants using binding ELISAs, MSD assays, and flow cytometry

Therapeutic Antibodies Assay Development Presentation Skills Critical Thinking

Immunoassays Benchling Results Analysis and Interpretation Project Planning and Development

Cell Binding Assays Process Development Adaptability Study Documentation

High-Throughput Assays & Robotics Data Analysis Cross Functional Collaboration Cross-Functional Collaboration

Biological Research Documentation Organized Document Organization

Flow Cytometry Regulatory Submission Multitasking Conflict Resolution

Research & Development Experimental Protocol Development Project Management Research Coordination

New Product Development SmartSheet Problem Solving Time Management

Publications MS Office Detail Oriented Active Listening Skills

Pharmaceuticals D360 Complex Problem-Solving Excellent Written and Verbal Communication

Biotechnology FileMaker Pro Research Coordination Quality Assurance

• Collaborated with multiple partners to prioritize and process projects according to company and FDA standards, ensuring timely submission of accelerated approval indication submissions while maintaining quality

• Analyzed data independently, offering insightful interpretation and troubleshooting. Developed proposals for next steps, guiding the direction of research and progress

Research Associate II/III

• Innovated screening processes and streamlined assays by designing programs on robotic systems like Tecan, Hamilton, and JANUS resulting in a reduction of 15% in processing time

• Modernizing the department's approach to drug discovery while elevating precision and efficiency and training fellow employees on methods and assays

• Expanded and maintained a diverse range of cell lines, enabling comprehensive characterization and downstream assays RECKITT BENCKISER INC.

Montvale, NJ

Assistant Scientist 2007 to 2009

• Quantified allergen removal of various cleaning products and formulations for claims substantiation

• Led comprehensive evaluations of cat, dog, mite, mold, and pollen allergens using ELISA-based methods

• Engineered Biomek and plate reader programs, automating previously manual test methods

• Conducted rigorous GMP testing using European and ASTM methods to evaluate the microbial efficacy of disinfectant products

• Innovated the creation of diverse antiseptic formulations, solubilizing oils, and non-water-soluble actives in various antiseptic formulations

• Spearheaded reformulating existing antiseptic products, aligning them with updated European and North American regulations while navigating regulatory landscapes to ensure compliance while maintaining effectiveness, and consumer trust and reducing product cost by 25%

• Utilized Minimum Bactericidal Concentration (MBC) and Minimum Inhibitory Concentration (MIC) values for various antimicrobial, surfactant, and inhibitor compounds

• Maintained meticulous documentation of all processes during experiments and fostered transparency and accountability, enabling accurate analysis and reproducibility of results

EDUCATION AND TRAINING

MASTER OF SCIENCE: Immunology and Microbiology

New York Medical College, Valhalla, NY

BACHELOR OF SCIENCE: Microbial Biotechnology and Microbiology; Minor in Biochemistry Rutgers, The State University of New Jersey, New Brunswick, NJ PROJECT MANAGEMENT PROFESSIONAL CERTIFICATION

PUBLICATIONS AND ACHIEVEMENTS

• "Studies in humanized mice and convalescent humans yield a SARS-CoV-2 antibody cocktail." (2020) Science 369 (6506): 1010-1014.

• “Development of Clinical-Stage Human Monoclonal Antibodies That Treat Ebola Virus Disease in Nonhuman Primates” (2018) The Journal of Infectious Diseases (218):612– 626.

• SIM Annual Meeting and Exhibition: Industrial Microbiology and Biotechnology. “Molds isolated in the aftermath of Hurricane Katrina: Identification of volatile organic compounds (VOCs) and their biological activity”

• SIM Annual Meeting and Exhibition. “Molds isolated in the aftermath of Hurricane Katrina: identification, cultivation, and production of volatile organic compounds (VOCs)”

• Microbiology Mini-Symposium. “Molds Isolated in the Aftermath of Hurricane Katrina: Identification, Cultivation, and Production of Volatile Organic Compounds (VOCs)” CERTIFICATIONS AND COURSES

• Specialization in Drug Development Product Management Courses

• Specialization in Clinical Trial Operations Courses

Contact this candidate