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Project Manager Resume

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Johns Creek, GA

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

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