Heather Mackey
Quality Control Specialist | Cell Thearapy
Talent
South San Francisco, San MateoMember since March 1, 2024
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About
- 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.
