Li-Pin (Betty) Kao, Ph.D., PMP

adf0fm@r.postjobfree.com; 480-***-****

PROFILE (but not limited to and my resume can be longer than 2 pages) 1. Currently a Regulatory Affairs at BD with ~10 years of research experience included post PhD, leading & managing biomedical research in small molecules and biologics developments, gene therapies, IVD, companion diagnosis, and medical device fields, respectively 2. A highly motivated driver and doer to achieve company’s goals. A team player in a collaborative workplace. 3. Experienced technical leader in biomedical researches (protein characterization, cardiovascular, Stem cells, Oncology, drug and biologic developments and lipid-based drug delivery, respectively. 4. Deep knowledge and hand-on experience of early and late medical devices’ development, manufacturing processes, quality system auditing, FDA filing, CMC strategy, cGMP, ICH guidance. 5. Strong research, scientific communication, and writing skills, proven by 17 High-profile scientific publications, including Toxicology and Applied Pharmacology, Journal of Lipid Research and PNAS, and 10 conference presentations, ad hoc manuscript reviewer experiences. EDUCATION

Ph.D., Biomedical Engineering, University of Queensland, Brisbane, Australia, 2009-2015 M.S., Biomedical Engineering, National Chiao-Tung University, Hsinchu, Taiwan, 2004-2006 B.S., Biochemistry, University of Otago, Dunedin, New Zealand, 1999-2002 LEADERSHIP (but not limited to the list below)

Project Leader, leading and communicating cross-function teams on both ends for Medical Device registration activities.

Technical Lead, Researcher managing product development towards FDA filing. PROFESSIONAL EXPERIENCE (but not limited to the list below) Regulatory Affairs Associate, BD., USA, 2019 to 2020

Lead and manage, strategized China, Taiwan and Hong Kong registration activities

Follow up with CAPA changes and proactive with solutions

Audit EU and US technical documentations

Serve as subject matter and regions’ specific regulation expert for internal/external customers and sets clear timelines & goals for assigned projects; prioritize efforts to deliver on time; provide excellent customer experience.

Collaborate with cross-functional departments to plan the necessary resources in order to guarantee a smooth and efficient execution of projects with optimized utilization of internal and external resources.

Proactively monitor CAPA, regions’ registration activities, regions’ regulations. Research Fellow and Postdoctoral Researcher (combination with regulatory Affair, GCP and GLP experiences), East Carolina University, Purdue University, and Mayo Clinic, USA, 2015 to 2019

Mentored PhD students and staffs and chaired four research projects.

Demonstrated leadership, mentorship, and teamwork through collaborative projects.

Involved with clinical trials to treat Leukemia and ensure compliance with ICH/GLP/GCP/IACUC/IRB, relevant SOPs’ and regulatory requirements, including research, investigation, & validation.

Allocating resources with continuous improvement and lean methodologies, toward to maintain quality by reducing

CRA and Lab Manager, Multi-Clinical sites, Taiwan, 2012 to 2015

Project with Clinical trial: Helicobacter pylori infection- A multicenter randomized comparative trial. Comply to ICH/IRB/ISO/IACUC/IRB protocols

Drug development project to investigate the relationship with nonalcoholic fatty liver disease.

Cross-functional communication with stakeholders on-site and remotely.

Led injectable drug development and cross-functional collaborations. Supervised research interns.

Reviewed, evaluated, verified, validated, and developed analytical test methods, protocols, and SOPs.

Mentored four MSc students and chaired projects.

Demonstrated leadership, mentorship, and teamwork through collaborative projects.deviations, CAPAs, and customer commitments.

PhD Graduate Researcher, Biomedical Engineering, University of Queensland, Australia, 2009 to 2015

Created amyloid -sheet peptides and peptide conjugates that inhibit protein aggregation related to Alzheimer’s disease and diabetes, providing potential therapeutic applications.

Demonstrated leadership, communication skill, teamwork, and productivity through cross-disciplinary projects resulting in publications in Toxicology and Applied Pharmacology, Stem Cells and PLoS One. SKILLS

Certificate: Project Management Professional (PMP) Certification (#1763996), USA Pharmaceutical/Medical device/Biologicals Training: Pharmacodynamic calculation, lean methodology, continuous improvement, investigation strategy, drug development, project management, KPI (key performance indicator), innovation management, leadership, interdepartmental communication, trained in Lead/Internal Quality auditor, cGMP, GLP, pharmaceutical regulatory affairs, SOPs. Chemical Synthesis, Purification, & Characterization: lipid emulsions, HPLC, AKTA prime, filtration, centrifugation, membrane separation, crystallization, lyophilizaiton. Biological Technique:

Molecular Biology

PCR/and RT-PCR, DNA/RNA extraction, DNA cloning and sequencing, full length CDNA cloning, vector design and constructions, gene mapping techniques, gene cloning techniques, site-direct mutagenesis, gene expression, inactivated viruses packaging, DNA microarray data analysis and interpretation, and genotyping during mice breeding.

Proteomic and Cell Biology and Animal Model

SDS-polyacrylamide gel electrophoresis, protein purification from E. coli by using chromatography and HPLC, flow cytometry, ELISA, immuno-staining (immunocytochemistry and immunohistochemistry, cell line culture, cell line development, embryonic stem cell culture), manipulation of mammalian cells (established the stable cell lines), functional assays using mammalian cell system (cell proliferation assay), conducting experiments (injection, tumor- transplant, feeding, and breeding) with genetically modified animal models (mice and rats). Computer Skills: MS Software, ChemDraw, Minitab

SELECTED PUBLICATIONS (17 in total)

• “Chemotherapy selection pressure alters sphinolipid composition and mitochondrial bioenergetics in resistant HL-60 cells” J. Lipid Res, 2019, 60(9):1590-1602. (First Author.)

• “Integration-free induced pluripotent stem cell model genetic and neural developmental features and down syndrome etiology.” Stem Cells. 2013, 31(3):467-478. (*Corresponding Author: Mentored Students for the project.)

https://pubmed.ncbi.nlm.nih.gov/?term=Kao%20LP&sort=date SELECTED CONFERENCE PRESENTATIONS (10 in total)

Kao LP., Potential therapeutic strategies in Cancer (2019). International Oncology Conference, Chicago, USA, Sep 26-27, 2019, Oral Presentation and Moderator

SELECTED HONORS AND AWARDS (7 in total)

Best oral presentation, International conference, Russia

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