Liquid Drug Product Development: Extensive experience in formulation and commercial process development for liquid drug products, ensuring high-quality outcomes and regulatory compliance. Vapor Phase Hydrogen Peroxide (VPHP) Expertise: Subject matter expert in VPHP decontamination processes for drug product formulations at commercial scale. Unit Operations and Scale-Up: Proficient in unit operations, including scale-down modeling, development, characterization, and scale-up for formulation, mixing, filtration, and aseptic filling processes. Protein Stability and Product Quality: Deep understanding of protein physical and chemical stability, with expertise in evaluating the impact of processing stresses on product quality. Late-Stage Product Development: Skilled in process characterization, equipment design and implementation, and technical transfers to global manufacturing sites. Proficient in statistical process control (SPC) and the statistical design and analysis of experiments (DOE). Regulatory Documentation: Authored Clinical Trial Applications (CTA) and Marketing Applications (MA), collaborating closely with Quality Control and Regulatory Agencies to ensure compliance with regulatory standards. Lab Safety Leadership: Served as Lab Safety Captain, overseeing monthly lab walkthroughs with Environmental Health teams to maintain a safe working environment. Conducted new hire lab safety orientations and acted as the primary contact for safety-related questions and concerns. Designed and implemented engineering and administrative controls in response to safety incidents, promoting a culture of safety.

Drug Product and Process Development: Contributed to the planning, design, execution, and documentation of studies supporting biologic therapeutic commercialization, including formulation and process development.Regulatory and Technical Documentation: Authored and reviewed technical protocols, reports, product impact assessments, and regulatory sections for INDs and marketing application submissions.Data Analysis and Visualization: Improved drug product design by leveraging IS systems, analyzing large datasets, and using statistical tools to generate actionable insights and visualizations.Manufacturing Support: Provided process capability analysis, troubleshooting, root cause analysis, and product impact assessments for clinical and commercial fill/finish manufacturing operations.Standardization and Best Practices: Enhanced departmental practices by developing guideline documents and co-authoring Vapor Phase Hydrogen Peroxide Spiking Studies for streamlined technology transfers.Cross-Functional Collaboration: Worked within global, matrixed teams to advance product development while ensuring alignment with organizational objectives.Leadership and Communication: Delivered progress reports and presentations to management, keeping stakeholders informed of project statuses, challenges, and needs.Training and Mentorship:Created the first video-based training for lab-scale filtration studies.Mentored high school students and maintained a biannual six-week lecture series for undergraduate and graduate students exploring roles in the pharmaceutical industry.Key Achievements:Drove innovation in training and education, fostering talent development and industry awareness.Supported successful technology transfers and process improvements through detailed analysis and collaborative solutions.

Experimental Techniques: Independently conducted experiments using established protocols, including Western Blot, qPCR, cDNA synthesis, RNA/DNA/Protein measurements, PCR, and extractions.Data Visualization and Communication: Tabulated and graphed experimental results, creating explanatory visual illustrations for publications and effectively communicating complex data to non-scientific audiences.Pharmacokinetics Modeling: Mathematically modeled plasma concentration curves using non-linear regression and Area Under the Curve (AUC) methodologies.Protocol Design: Contributed to the design of research protocols, ensuring methodological rigor and alignment with project goals.Fluorescent Labeling: Conducted fluorescein isothiocyanate (FITC) labeling for recombinant human biologics.Primer and Probe Design: Designed primers and probes for targeted applications using genomic sequencing software.Publication and Peer Review: Published findings in peer-reviewed journals (see publications).Key Achievements:Developed accurate and reproducible methodologies for molecular biology research.Translated complex scientific data into accessible formats for diverse audiences.Contributed to high-impact publications and advanced understanding in key research areas.

Course Management: Coordinated the Canvas platform for file submissions and structured Zoom meetings seamlessly integrated with Canvas.Student Engagement: Established presentation agendas, facilitated hosting sessions and managed student concerns directly to ensure a supportive learning environment.Feedback and Evaluation: Organized interdisciplinary feedback groups for semester assignments, gathered speaker feedback, and disseminated insights effectively.Assessment and Data Collection: Evaluated assignments as “complete” or “incomplete” and created surveys to collect and analyze student data.Key Contributions:Streamlined course administration and virtual meeting management during a hybrid learning period.Fostered collaboration and feedback across diverse academic disciplines and seniority levels.

Behavioral Analysis: Conducted behavioral studies using the Morris Water Maze to assess spatial learning and Ethovision software for behavioral tracking.Auditory Processing Studies: Utilized the acoustic startle paradigm to evaluate auditory processing in laboratory rats.Animal Care and Compliance: Maintained the housing facility for rats, assisting the IACUC chair to ensure ethical and compliant animal care.Research Coordination: Collaborated with the Principal Investigator (PI), providing weekly updates on project goals, progress, and animal welfare concerns.Key Contributions:Ensured high standards of animal care and compliance with IACUC guidelines.Effectively supported behavioral research through advanced tracking systems and methodologies.

Zebrafish Pilot Feeding StudyResearch Leadership: Led a pilot feeding study investigating the impact of dietary changes on zebrafish reproduction rates and behavior.Protocol Management: Assisted in preparing protocol approvals and amendments to ensure compliance with research standards.Facility Setup and Procurement: Established a new zebrafish facility at Regis College and coordinated procurement from the Zon Lab.Animal Care and Maintenance:Monitored water quality parameters (pH, conductivity, NH₃, NO₂, NO₃) and performed daily animal care.Followed SOPs for water changes, tank cleanings, and euthanasia/anesthesia procedures as needed.Key Contributions:Successfully initiated and managed a zebrafish research facility.Ensured high standards of animal welfare and protocol compliance throughout the study.

Microscopy and Imaging: Utilized Stereo Investigator and advanced microscopy techniques (multi-channel fluorescence, confocal, structured illumination) to analyze neurons in rodent brains with periventricular nodular heterotopias.Data Analysis: Conducted statistical analysis using SPSS (± S.E.M, one-way ANOVA, Tukey HSD) to interpret experimental results.Research Communication: Presented findings from preliminary analyses at the Northeast Undergraduate Research on Neuroscience (NEURON) Conference (Feb 2018).Literature Review: Conducted general and specialized database searches to support research objectives.Manuscript Preparation: Assisted in drafting formal research reports and manuscripts for publication.Key Contributions:Delivered data-driven insights through advanced imaging and statistical analysis techniques.Represented research findings at a recognized neuroscience conference, enhancing visibility and impact.

Direct Patient Care: Delivered patient care in a clinical setting, participating actively in therapeutic milieu and group therapy sessions.Therapeutic Relationship: Established and maintained professional boundaries while building trusting therapeutic relationships with patients.Crisis Prevention: Identified behaviors contributing to potential crises and took appropriate actions to mitigate risks.Specimen Collection: Collected patient specimens as required, ensuring proper handling and documentation.Team Collaboration: Reported patient behavior and progress to the team leader during weekly rounds to support coordinated care planning.Key Contributions:Contributed to effective group therapies and crisis management strategies in a clinical environment.Collaborated with the care team to enhance patient outcomes and ensure comprehensive treatment planning.

Personal Hygiene Support: Assisted patients with personal hygiene, grooming, and toileting, including bedpans and commodes, ensuring dignity and comfort.Patient Observation and Documentation: Monitored patient status, reporting changes and documenting care provided to ensure accurate records.Therapeutic Exercises: Administered range of motion exercises and ensured proper patient positioning to promote comfort and mobility.Key Contributions:Provided compassionate support in daily activities while maintaining patient dignity and comfort.Contributed to effective care planning and patient monitoring through thorough documentation and observation.