Senior Analyst, Quality Control Analytical

About GeneFab

GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. Formed in 2023, GeneFab combines industry-leading expertise in synthetic biology with advanced cGMP capabilities to accelerate the development and commercialization of genetic medicines. The company offers an extensive technology platform spanning early-stage product design, technical development, and cGMP-compliant production, including bioinformatic-guided discovery of cell-type promoters, directed evolution of small molecule-regulated gene switches, and engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.

Responsibilities

• Provide technical expertise (SME) and support to Analytical Development and QC Analytical Operations as needed.
• Develop, 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 testing.
• Lead and perform technical root-cause investigations for aberrant results and deviations relating to analytical methods.
• Lead and train junior employees to ensure testing procedures and practices comply with all applicable regulations and procedures.
• Plan, lead, and execute analytical method transfers, qualifications, and validations.
• Draft, review, and approve Method Transfer Protocols and Reports.
• Generate and review procedures, protocols, and reports.
• Proactively identify areas for continuous improvement in processes and procedures and lead these initiatives.
• Collaborate closely with interdepartmental MSAT, ASAT, and Manufacturing groups to support, execute, and/or provide oversight in method optimization, characterization, troubleshooting, transfer, and qualification.
• Perform additional duties as assigned.

Requirements

• B.S. degree in biology or a related field with experience in cell therapy, immunology, cancer biology, or a closely related field.
• Minimum of 5+ years of GMP/QC Laboratory experience.
• Demonstrated ability to collaborate and work in cross-functional teams.
• Strong organizational skills and attention to detail.
• Strong time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Experience with relevant technologies such as multicolor flow cytometry, cell culture (e.g., aseptic techniques, cell line expansion), multiplexed immunoassay, qPCR, dPCR methods, Luminex, and ELISA.
• Experience in GMP.
• 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 cell therapy or gene therapy is a plus.
• Availability to work extended hours such as evenings or weekends 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.
• Able to lift up to 40 pounds.