Manager/Sr. Manager, Analytical Development

The Manager/Sr. Manager in Analytical Development will lead a team supporting analytical method development, optimization, testing supporting process development and transfer activities for cell and gene therapy programs. The ideal candidate will have strong technical expertise — particularly in flow cytometry, ELISA, cell-based assays, and qPCR/dPCR — as well as demonstrated leadership skills and hands-on experience supporting viral vector and cell therapy products. This is a player-coach role: you’ll guide and grow a team while actively contributing to laboratory work and cross-functional collaboration. Level/title (Manager or Senior Manager) will be determined based on the candidate’s experience and qualifications.

Key Responsibilities:

• Lead and mentor a team of scientists and analysts supporting analytical development projects for viral vector and cell therapy programs
• Provide day-to-day guidance on scientific strategy, assay development, troubleshooting, and resource planning
• Design, develop, and optimize analytical methods (e.g., flow cytometry, ELISA, cell-based potency assays, qPCR/dPCR)
• Oversee routine testing activities, including in-process and release testing to support process development
• Act as a subject matter expert (SME) in client and cross-functional meetings (e.g., PD, QC, Manufacturing, MSAT, Regulatory)
• Support the transfer of assays into and out of the Analytical Development team, including to QC labs and from clients
• Implement statistical tools and design of experiments (DOE) to ensure robustness and reliability of assays
• Participate in assay qualification and validation planning and execution
• Collaborate with QC to ensure smooth analysts training and transfer of assays for lot release and stability testing
• Troubleshoot method performance issues and drive continuous improvement initiatives
• Assist in drafting protocols, reports, and technical documentation
• Evaluate new and innovative technologies for implementation into AD and QC
• Maintain compliance with internal quality systems and relevant regulatory guidelines
• Foster a culture of scientific excellence and mentor team members
  
  
  

Requirements:

• MS with 6+ years, or PhD with 3+ years in analytical development in cell and gene therapy
• Proficiency in a broad range of analytical techniques used in cell and gene therapies (qPCR/dPCR, Flow Cytometry, ELISA). Extensive flow cytometry experience is strongly preferred
• Demonstrated ability to lead or mentor scientific staff, manage lab operations, and prioritize work across multiple projects
• Strong understanding of regulatory requirements for method development and transfer (ICH, FDA, EMA, etc.)
• Experience collaborating across CMC functions (PD, QC, MSAT, Manufacturing, etc.)
• Good understanding of ICH guidelines for assay qualification/validation
• Basic understanding of method lifecycle management from development to validation and beyond
• Ability to analyze and interpret data and contextualize with the program goals and requirements in a phase-appropriate manner
• Ability to manage timelines and resources effectively
  
  
  

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.