I am partnering with H&H as a Clinical Relations and Project Management VP.https://healthnheaven.com

• Develop comprehensive project plans with clear timelines, milestones, resources, and budgets, ensuring timely delivery within State of California and Federal regulations.• Establish strong stakeholder relationships through regular communication updates and clear communication channels.• Monitor project performance, identify gaps, and recommend improvements aligned with company values.

• Directed a high-performing protein chemistry team for allergen production supporting allergy diagnostics.• Ensured regulatory compliance with GMP, QSR, EH&S, FDA & ICH regulations and constrains.• Assisted in preparing and submitting FDA, Due Diligence, POC, 21 CFR 820, ISO 13485, 510K, IVDD, and IVDR documentation for NOVEOS and NOVEOS flex diagnostics platforms.• Achieved project milestones within established timeframes and budget through close cross-department collaboration.• Implemented interdepartmental strategies (Chemistry, QC & Manufacturing) by identifying procedural gaps and discrepancies, improving efficiency and quality.• Negotiated and onboarded qualified vendors, reducing monthly costs by 30%.• Mitigated risks by effectively communicating with upper management, stakeholders, and vendors ensuring smooth project progress.

• Planned and executed method development and validation for API/DS and DP in a cGMP environment, adhering to ICH and FDA regulations.• Delivered departmental performance goals, ensuring consistent revenue flow.•Served as SME, guiding project managers and collaborating with cross-functional teams to meet milestones within budget and schedule.• Prepared quality technical documentation, conducted complex testing, and provided data analysis for stakeholder presentations.• Managed an annual department budget of $100K for equipment, software, and resources.

• Managed all aspects of the project management process from planning to closure• Contributed to the commercialization of a PEGylated nanopeptide drug delivery agent from feasibility to pre-commercialization• Planned drug delivery lab projects, including contracts, scope of work, documentation, and resource forecasting• Monitored project progress and provided regular updates to upper management• Facilitated business development meetings with internal and external stakeholders and contractors using virtual communication tools• Identified project risks and developed mitigation strategies with team members• Analyzed data and reviewed ICH guidelines to assess companion documents, APIs, and DS of new compounds• Oversaw the scientific team of 3 scientists, identified action items, held the team accountable, and prepared reports and presentations for stakeholders.

• Led multiple research projects with cross-functional teams, securing a $250K NIH grant and obtaining Health Department approval.• Designed and executed innovative drug delivery research, ensuring projects were completed within scope and on time.• Managed project documentation, including SOPs, protocols, and manuscripts, ensuring regulatory compliance with FDA, EH&S, and OSHA standards.• Provided mentorship and training to graduate students and lab personnel, fostering a collaborative and high-performing team environment.• Monitored and maintained lab equipment functionality through collaboration with vendors, ensuring project continuity and efficiency.

• Led prostate cancer and NF-KB pathway projects, coordinating with cross-disciplinary teams to achieve key research milestones.• Secured a $50K DOD grant through effective communication and collaboration with the grant-writing team, contributing to the project's financial success.• Developed and maintained a strong understanding of regulatory standards (cGMP, GLP, GDP, ICH, ISO, CFRs), ensuring compliance in all project phases.• Fostered a collaborative environment, leveraging interpersonal skills to optimize team performance and project outcomes.• Contributed specialist input and insights to research activities, driving innovation and achieving research goals.•Engaged in scientific research on multiple projects, collaborating with interdisciplinary teams to drive innovations.

• Conducted eight successful mutations on the LPL gene, contributing to potential treatment developments.• Performed comprehensive literature reviews to inform study design and methodology, ensuring alignment with project objectives.• Mastered complex molecular biology techniques, providing valuable contributions to research initiatives.

• Evaluated the clinical drug development process from preclinical to phase III to marketing;• Inspected and reported the reasons for failure of 10 drugs developed in phase II and III;• Knowledgeable to design successful drug development plans by considering well-proposed hypotheses, biomarkers, methodologies, therapeutic PK/PD , target modulation, dose response, exposure response, and in vitro /in vivo/ in human interrelation;• Contributed to a non-profit organization, MRF, in accelerating time to market for new medicines.

Pioneered the development and validation of magnetite nanoparticles (PAMF) as a biocompatible and versatile cancer drug delivery system. Innovative Problem-Solver: - Successfully saved six months of experimental work during a university-wide power outage by quickly coordinating with other departments, securing alternate lab space, and maintaining the continuity of critical experiments.- Verified PAMF’s biocompatibility, biodistribution, and anticancer effects in healthy and tumor-bearing mice, using an alternating magnetic field to induce hyperthermia.- Leveraged a wide array of methodologies including NMR, MTT, AgNOR staining, IHC, FACS, blood analysis, microsurgery, histology, microscopy (light and electron), mitotic index, genotoxicity assay, cell death assay, solid tumor inoculation, and tissue culture.- Collaborative Innovator: Invented two new AC device prototypes and upgraded existing equipment for MHT purposes by collaborating with national and international engineering departments.Conducted statistical data analysis with SPSS15, applying Means, t-test, ANOVA, and Mann-Whitney tests to ensure robust and accurate results.- Developed and implemented new protocols and SOPs for tumor inoculation, processing, and staining, optimizing procedures for NMR and microscopic analysis.Mentor and Educator: Taught immunology and histology to undergraduate students and provided mentorship, fostering the next generation of scientists.- Regularly attended conferences to stay at the forefront of cancer research and drug delivery technologies, contributing to ongoing professional development.

• Provided full-scope midwifery care to women and neonates in hospital and at home;• Provided counseling and psycho-socio-emotional support; • Assisted with CQI program and initial set-up of two women centers for full-scope midwifery services and a center for Labor-Delivery-Recovery-Postpartum operation;• Successfully implemented educational public workshops, seminars, and presentations in order to increase women and targeted population general health, diseases, and prevention awareness;• Supervised the patient’s care team, identified, planed, implemented and evaluated the nursing care requirements for patients.