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) Specialist 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.

The individual will work cross-functionally with QC, QA, Manufacturing, and AD teams to support clinical and commercial tech transfer activities.

What you'll do

• Provide technical expertise (SME).
• Support Saturday and Sunday GMP manufacturing operations.
• Plan, lead, and execute analytical method transfers, qualifications, and validations.
• Develop, implement, and update all Quality Control SOPs, test records and other documentation needed for cGMP compliance.
• Provide technical support to Analytical Development and QC Analytical Operations as needed.
• Perform GMP analytical testing for in-process, release, characterization, and stability samples.
• Participate in laboratory investigations including OOS, OOT, deviations, laboratory errors, and CAPAs.
• Participate in Risk Assessments and Continuous Improvement initiatives.
• Draft, Review, and Approve Method Transfer Protocols and Method Transfer Reports.
• Generate and review procedures, protocols and reports.
• Proactively identify areas for continuous improvement in processes and procedures and lead these initiatives.
• Maintain laboratory readiness for internal, client, and regulatory inspections.
• Perform data review to ensure accuracy, completeness, and ALCOA+ data integrity principles.
• Perform additional duties as assigned.

Knowledge and Skills

• Strong understanding of cGMP regulations (21 CFR Parts 210, 211, and 1271).
• Knowledge of USP requirements applicable to biologics and cell therapy.
• Familiarity with ICH guidance and ALCOA+ principles.
• Excellent laboratory documentation practices.
• Strong analytical and troubleshooting skills.
• Ability to manage multiple priorities in a fast-paced CDMO environment.
• Strong written and verbal communication skills.
• Ability to work independently with minimal supervision.
• Demonstrated attention to detail and commitment to quality.

Qualifications

• Bachelor’s degree in biology, chemistry, biochemistry, or related scientific discipline; advanced degree is a plus. 
• Minimum of 5+ years of GMP Quality Control laboratory and Method Transfer experience in Cell Therapy, Gene Therapy,
• Hands-on experience with cell therapy-related analytical methods such as cell culture, flow cytometry, ELISA, dPCR, qPCR, and cell-based assays. 
• Strong understanding of GMP, ICH, USP, and regulatory requirements applicable to biologics/cell therapies.
• Experience with contract laboratories and or CDMO is a plus  
• Excellent organizational, communication, and leadership skills.
• Experience supporting clinical and commercial manufacturing.
• Proficiency in electronic systems such as ELN, LIMS and Veeva. 
• Comfortable in a fast-paced, dynamic biotech environment with shifting priorities. 
• Demonstrated ability to foster a culture of accountability, quality, and continuous improvement. 
• May need to support and/or execute analyst tasks on a non-routine basis.