Michael Funaro Email & Phone Number

Academic tutoring for high school students in AP level mathematics and science courses and SAT/ACT prep.

Orange County, California Area

My primary area of focus is in the STEM curriculum. I constructed an analytical framework to organize learning outcomes in core classes as well as in standardized testing material. I utilize the framework to design assessments to monitor student progress and identify learning gaps. In relation to the curriculum itself, I create and instruct new science and engineering classes, targeted to students interested in research and design, by providing more hands on laboratory time and exposure to technology.

Worked to develop, validate and execute analytical chemistry methods as well as write and execute validation reports. Lead the implementation of a Quality Management System at the company by drafting SOP's for analytical methods, and performing IQ/OQ/PQ on new laboratory equipment. I authored part of the CMC section for the company's IND application with the FDA. As an engineer, I was the lead designer for new drug delivery devices as well as customized packaging for each device. I also have experience in product manufacturing (cGMP) of several drug formulations for pre-clinical and clinical studies per 21 CFR 211 in a Class 10,000 clean room.

Northridge, Ca

Performed quality control testing of drug eluting medical devices utilizing UPLC/HPLC and GC methods under ISO 9001 quality management standards and FDA QSR (21 CFR 820) .

Framingham, Ma

• Investigated the maximum drug loading of a polymer for a study utilizing DSC• Verified the drug concentrations using HPLC analysis for dosing during pre-clinical studies• Assisted in tissue necropsy and analysis of pharmacokinetic data• Monitored and recorded particle size data in process of a pilot scale manufacturing study• Experimented with multiple polymers for designing various drug delivery vehicles such as micelles, films and gels• Practiced aseptic technique in preparation of materials for animal implantation• Lyophilized various products to achieve formulation stability• Studied the solubility of hydrophobic active ingredients for the purpose of formulation stability

Fort Washington, Pa

• Created various formulations for a controlled release product using various lab scale processes for blending, granulation, milling, coating and tablet compression • Formulated products with different controlled release mechanisms including ion exchange resins, polymer matrix systems and osmotic pressure release tablets• Analyzed product candidates through the environmental stability chambers, through dissolution experiments and through the use of an electron microscope • Manipulated pharmacokinetic behavior through formulation changes based on analytical data• Prepared samples under cGMP for clinical trials

M.S., Biomedical Engineering

B.S., Bioengineering