Quality Control Analyst I​/II

Gene Fab 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 detail
• Perform QC testing on raw materials, in-process and final product samples
• Assess data to ensure product specifications are met
• Assist in reviewing data
• Perform technical root-cause investigations for aberrant results and deviations relating to analytical methods
• Responsible 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 qualification
• Perform additional duties as assigned

Qualifications:

• 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 methods
• Experience with relevant QC Microbiological assays is a plus
• Experience with assay development, method qualification, and routine testing in GLP and/or GMP environment
• Experience with contract laboratories and or CDMO is a plus
• Knowledge related to laboratory information management systems (LIMS) and electronic lab notebook record keeping (ELN) is a plus
• Proficient in MS Word, Excel, Project, and Power Point
• Experience with gene and cell therapies or the pharmaceutical industry is a plus
• Availability to work extended hours to meet deadlines when necessary
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of the initial job description

Salary and Benefits:

• The base salary range for this role is $35-45; starting pay is determined by multiple job-related factors including a candidate's skills, education and experience level, benchmark, and internal parity
• We 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 expands

$35 - $45 an hour

About Gene Fab

Gene Fab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. Gene Fab 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. Gene Fab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production.

Gene Fab'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 Gene Fab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse Gene Fab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.