Project Manager Resume Johns Creek, GA - Hire IT People

PROFESSIONAL EXPERIENCE:

Confidential, Johns Creek, GA

Project Manager

Responsibilities:

Responsible for dept. meeting FDA and regulatory standards.
Consult stakeholders to define requirements and scope of sub - projects lasting 2 weeks to 1 year.
Create work schedules and ensure resource availability for analysts.
Present team updates to senior management.
Managed 4 multi-state validations to ensure on-time prod. line validation
Delivered 8 sub-projects for $100M+ project w/avail. resources on time to enable registration clinical trial

Associate Research Scientist

Confidential

Responsibilities:

Manage R&D product development projects.
Responsible for developing and validating analytical methods to meet regulatory reqs. for clin. trials.
Function as design control engineer on projects. Lead multi-site analytics collaborations.
Delivered 4 validated analytical methods on time for a major clinical trial by proactively upskilling 2 scientists
Formatted and indexed entire medical device Design History File of best-selling product thru collab. w/SMEs
Enabled gate approval of $20M+ project by leading 7 geo-distributed scientists to investigate 2 toxicity risks

R&D Lab Assistant

Confidential

Responsibilities:

Develop and perform analytical tests in compliance w/ FDA and company guidelines. Write SOPs.
Ensured safety of critical raw material in $100M+ project by developing/validating impurity assay
Saved 2 projects from entering full scale up phase by performing analyses to show poor product stability

Confidential, Norcross, GA

Analytical Chemist

Responsibilities:

Set up analytical lab for a startup company.
Ensure analytical methods for customers are accurate and in compliance with FDA regulations.
Analyze tinctures and other homeopathic products.
Won back company’s first return customer by connecting customer needs and FDA approved methods
Prepared lab and QA department for company’s first successful FDA audit

Confidential, Flowery Branch, GA

R&D Lab Technician

Responsibilities:

Analyzed drug development products and incoming raw materials under regulatory compliance.
Demonstrated product stability in 5+ formulations by assaying 15+ stability pulls with chromatography