GeneFab
Quality Control Analyst I/II
GeneFab, Alameda, California, United States, 94501
GeneFab is seeking a Quality Control Analyst I/II to help ensure consistent quality of our cell manufacturing process. You will perform laboratory tests on incoming raw materials, in-process samples, and final product samples before distribution. You will carefully and consistently analyze this data to ensure product specifications are met, or perform peer reviews of other analyses. As part of this role, you will also review current GMP documentation related to SOPs, testing methods, and protocols.
Responsibilities:
Successfully execute and document laboratory procedures and experiments with great attention to detailPerform QC testing on raw materials, in-process and final product samplesAssess data to ensure product specifications are metAssist in reviewing dataPerform technical root-cause investigations for aberrant results and deviations relating to analytical methodsResponsible for raw materials inspection, sampling and testing in support of clinical and commercial products in compliance with GMP requirements.Collaborate closely with Interdepartmental MSAT and Manufacturing groups to support, execute, and/or provide oversight in the execution of method optimization, characterization, troubleshooting, transfer, and qualificationPerform additional duties as assignedQualifications:
B.S. degree in biology or related field with experience in cell therapy, immunology, cancer biology, or a closely related field, and 0-3 years (QC Analyst I) or +3 years of industry experience (QC Analyst II)Experience with relevant technologies with an emphasis on multicolor flow cytometry, MSD, Immunospot, cell culture (e.g., aseptic techniques, cell line expansion), multiplexed immunoassay, NGS, qPCR, and dPCR methodsExperience with relevant QC Microbiological assays is a plusExperience with assay development, method qualification, and routine testing in GLP and/or GMP environmentExperience with contract laboratories and or CDMO is a plusKnowledge related to laboratory information management systems (LIMS) and electronic lab notebook record keeping (ELN) is a plusProficient in MS Word, Excel, Project, and PowerPointExperience with gene and cell therapies or the pharmaceutical industry is a plusAvailability to work extended hours to meet deadlines when necessaryComfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing prioritiesSelf-motivated, detail-oriented, and willing to accept temporary responsibilities outside of the initial job descriptionSalary and Benefits:
The base salary range for this role is $75,000 - $98,000.00; starting pay is determined by multiple job-related factors including a candidate’s skills, education and experience level, benchmark, and internal parityWe offer an excellent benefits program including a selection of Medical, Dental and Vision plans, FSA, HSA, Company paid holidays, employee assistance program, commuter benefits, wellbeing resources, perks and more!Significant growth opportunity as the company expandsAbout GeneFabGeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.
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Responsibilities:
Successfully execute and document laboratory procedures and experiments with great attention to detailPerform QC testing on raw materials, in-process and final product samplesAssess data to ensure product specifications are metAssist in reviewing dataPerform technical root-cause investigations for aberrant results and deviations relating to analytical methodsResponsible for raw materials inspection, sampling and testing in support of clinical and commercial products in compliance with GMP requirements.Collaborate closely with Interdepartmental MSAT and Manufacturing groups to support, execute, and/or provide oversight in the execution of method optimization, characterization, troubleshooting, transfer, and qualificationPerform additional duties as assignedQualifications:
B.S. degree in biology or related field with experience in cell therapy, immunology, cancer biology, or a closely related field, and 0-3 years (QC Analyst I) or +3 years of industry experience (QC Analyst II)Experience with relevant technologies with an emphasis on multicolor flow cytometry, MSD, Immunospot, cell culture (e.g., aseptic techniques, cell line expansion), multiplexed immunoassay, NGS, qPCR, and dPCR methodsExperience with relevant QC Microbiological assays is a plusExperience with assay development, method qualification, and routine testing in GLP and/or GMP environmentExperience with contract laboratories and or CDMO is a plusKnowledge related to laboratory information management systems (LIMS) and electronic lab notebook record keeping (ELN) is a plusProficient in MS Word, Excel, Project, and PowerPointExperience with gene and cell therapies or the pharmaceutical industry is a plusAvailability to work extended hours to meet deadlines when necessaryComfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing prioritiesSelf-motivated, detail-oriented, and willing to accept temporary responsibilities outside of the initial job descriptionSalary and Benefits:
The base salary range for this role is $75,000 - $98,000.00; starting pay is determined by multiple job-related factors including a candidate’s skills, education and experience level, benchmark, and internal parityWe offer an excellent benefits program including a selection of Medical, Dental and Vision plans, FSA, HSA, Company paid holidays, employee assistance program, commuter benefits, wellbeing resources, perks and more!Significant growth opportunity as the company expandsAbout GeneFabGeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.
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