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Find professionals and candidates asynchronous task processingHeather Mackey

Heather Mackey

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.

Reviews

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