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.
About the role
The Senior Quality Control (QC) Analyst is responsible for performing GMP analytical testing to support the manufacture and release of Cell Therapy and Gene Therapy products in a contract development and manufacturing organization (CDMO). This role performs complex laboratory testing, ensures compliance with GMP requirements, assists with method qualification and transfer activities, investigates laboratory events, and mentor’s junior analysts. The successful candidate will possess strong technical expertise in cellular and molecular analytical methods, maintain high-quality laboratory documentation, and support a fast-paced, client-focused manufacturing environment.
This position supports the weekend operations and collaborates closely with Manufacturing, QA, Process Development, MSAT, and clients to ensure timely release of clinical manufacturing batches.
What you'll do
- Provide technical expertise (SME).
- Provide technical 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 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.
- Minimum of 5+ years of GMP/QC Laboratory experience in Cell Therapy, Gene Therapy.
- 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, and 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