Senior QC Analyst, Quality Control Analytical

Genefab is seeking an experienced analyst to join it’s Quality Control Analytical group. In this role, you will support the GMP QC testing at GeneFab, with a focus on testing, method transfer, qualification, troubleshooting and investigations.ResponsibilitiesProvide technical expertise (SME)Provide technical support to Analytical Development and QC Analytical Operations as neededDevelop, implement, and update all Quality Control SOPs, testing records and other documentation needed for cGMP compliance. Perform QC testing on in-process and final product samples to support release and stability testingLead and perform technical root-cause investigations for aberrant results and deviations relating to analytical methodsLead and train junior employees to ensure testing procedures and practices comply with all applicable regulations and proceduresPlan, lead, and execute analytical method transfers, qualifications, and validationsDraft, Review, and Approve Method Transfer Protocols and ReportsGenerate and review procedures, protocols and reportsProactively identify areas for continuous improvement in processes and procedures and lead these initiativesCollaborate closely with Interdepartmental MSAT, ASAT, and Manufacturing groups to support, execute, and/or provide oversight in the execution of method optimization, characterization, troubleshooting, transfer, and qualificationPerform additional duties as assigned RequirementsB.S. degree in biology or related field with experience in cell therapy, immunology, cancer biology, or a closely related fieldMinimum of 5+ years of GMP/QC Laboratory experienceDemonstrated ability to collaborate and work in cross-functional teamsStrong organizational skills and attention to detailStrong time management skills with a proven ability to meet deadlinesStrong analytical and problem-solving skillsExperience with relevant technologies such as: multicolor flow cytometry, cell culture (e.g., aseptic techniques, cell line expansion), multiplexed immunoassay, qPCR, and dPCR methods, Luminex, and ELISAExperience in GMPExperience 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 cell therapy or gene therapy is a plusAvailability to work extended hours such as evenings or weekends 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 descriptionAble to lift up to 40 poundsAbout 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.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.