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Heather Mackey

Heather Mackey

Quality Control Specialist | Cell Thearapy

Pharmaceutical / Bio-tech

South San Francisco, San Mateo

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1 Followers

About Heather Mackey:

  • Over 10 years of experience in the cell therapy space, specializing in autologous and allogeneic cell therapies, including CAR-T and NK cells.
  • Extensive background in cGMP environments, ensuring compliance with FDA regulations and documentation requirements.
  • Proficient in a wide range of laboratory techniques, including flow cytometry, ELISA, cell culture, and PCR.
  • Skilled in assay development, validation, and troubleshooting, with a focus on quality control and deviation management.
  • Excellent technical writing and communication skills, with a track record of contributing to method validations and regulatory filings.

Experience

  • Over 10 years of experience in quality control and research within the biotechnology industry.
  • Proficient in conducting quality control assays and ensuring compliance with regulatory standards.
  • Skilled in stem cell culture, molecular biology techniques, and laboratory automation.
  • Proven track record of effectively collaborating with multidisciplinary teams to achieve project goals.
  • Strong attention to detail, commitment to excellence, and adept at problem-solving in fast-paced environments.

Education

  • Bachelor of Science in Bology with a focus on biology and chemistry.
  • Completed coursework in molecular biology, cell biology, and laboratory techniques.
  • Received specialized training in quality control methodologies and regulatory compliance.
  • Continuously pursued professional development opportunities to stay updated with industry advancements and best practices.

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