Project Manager Resume

SUMMARY

I am a project manager who specializes in leading medical device, biotech, and pharmaceutical projects.
Abroad scientific background and sharp attention to detail give me the ability to effectively manage all aspects of a development program.
My leadership style avoids gimmickry and short term thinking, and instead develops realistic paths to achieving objectives, creates conditions that allow employees to perform their best, and implements common sense practices to ensure the highest quality products.

TECHNICAL SKILLS

Project Management Analytic & Synthetic Chemistry Product Validation
Product Launches/Technology Transfers New Product Development Statistical Data Analysis Design History Files/SOPs Risk Management Grant Writing
Product Failure Investigations Excel/EEPROM Programming 9001 Auditing

PROFESSIONAL EXPERIENCE

Confidential

Project Manager

Developed chemical process for a portable gas mask which regenerates oxygen from exhaled carbon dioxide.
Received patent #7,225,806 for gas mask.
Helped design process for creating artificial joints in vivo via SLA solidification of silicone.
Designed marketing presentations for potential licensees and investors.
Performed feasibility and risk evaluation of new scientific and engineering proposals.
Worked with outside attorneys to review intellectual property claims.
Managed design history files and finances for projects.

Confidential

Associate Program Manager

Directed projects to create veterinary and encrypted coagulation devices for outside companies.
Oversaw integration of acquired co oximetry device into company project and quality systems.
Managed phase IV (post - launch) administration of multiple device product lines.
Oversaw clinical trials conducted in-house and by external development partner.
Coordinated move of laboratories and offices to a new facility. Named premier performer (employee of the quarter) for directing relocation.
Served on material review board to evaluate non-conforming product. Assigned and evaluated

Confidential

Quality Assurance Scientist

Wrote validation protocols and reports for quality control and manufacturing processes.
Developed new techniques for testing blood coagulation instruments in a QC lab.
Investigated and tracked product failures as part of CAPA process.
Conducted vendor audits. Certified in 9001 auditing.

Confidential

R&D Scientist

Assisted in the design of hemoglobin assay reagent and strip. Received patent #7,379,167.
Conducted EEPROM software programming of OEM instrument.
Coordinated and wrote reports for product validations and 510k testing.
Helped initiate and develop a one-step hemoglobin assay.
Created a company-wide policy for evaluation of outlying data.
Developed chemical safety policy, and held responsibility for all R&D laboratory equipment.
Designed and maintained interdepartmental Excel search engines to monitor in-house blood donations.