The Role
Perform and document GMP-aligned QC testing on raw materials, in-process, and final cell therapy products. Analyze data, perform peer reviews, investigate aberrant results, inspect and sample raw materials, and support method optimization, transfer, and qualification in collaboration with MSAT and Manufacturing teams.
Summary Generated by Built In
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 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 PowerPoint
- 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
About GeneFab
GeneFab 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.
Skills Required
- B.S. degree in biology or related field and 0-3 years (QC Analyst I) or 3+ years (QC Analyst II) industry experience
- Experience with multicolor flow cytometry
- Experience with MSD
- Experience with Immunospot
- Experience with cell culture (aseptic techniques, cell line expansion)
- Experience with multiplexed immunoassay
- Experience with NGS, qPCR, and dPCR methods
- Experience with QC microbiological assays
- Experience with assay development, method qualification, and routine testing in GLP and/or GMP environment
- Experience with contract laboratories and/or CDMO
- Knowledge of laboratory information management systems (LIMS) and electronic lab notebook (ELN)
- Proficiency in MS Word, Excel, Project, and PowerPoint
- Experience with gene and cell therapies or pharmaceutical industry
- Availability to work extended hours to meet deadlines
- Ability to work in a fast-paced environment with minimal direction and adjust workload based on changing priorities
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside initial job description
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The Company
What We Do
GeneFab is a contract development, manufacturing, and synthetic biology biofoundry focused on cell and gene therapies. The company bridges innovation and manufacturing with end-to-end biotechnology services, combining computational design and data analysis with cGMP-compliant production to advance genetic medicines from concept to clinic, partnering with innovators to deliver life-changing therapies to patients in need.
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