Contract Scientist, Analytical Development

The Scientist in Analytical Development will assume a pivotal role within GeneFab’s Technical Development department, executing against and supporting oversight of the analytical functions (method development, qualification, routine testing, and new technology evaluation) that are integral to the successful development and manufacturing of cell and gene therapy products for new or existing clients. The scientist will also support activities required for GMP readiness (qualification protocol and report writing, qualification planning and strategy and method lifecycle management). 

• Lead the transfer of assays from assay development teams (internal or client) to Quality Control (QC), including assessment of assays readiness, possible gaps and required optimizations. 

• Author and review test methods and SOPs. 

• Take a lead role in assay qualification/validation activities, including partnering with QC, planning qualifications/validations, data analysis and interpretation. 

• Write transfer/qualification/validation protocols and reports in accordance to regulatory guidelines. 

• Provide technical expertise and support to QC for investigations and troubleshooting activities. 

• Represent GeneFab in analytical SME-to-SME meetings with current and prospective clients as well as in internal meetings. 

• Collaborate with cross-functional teams, including assay development, process development, MSAT, manufacturing and quality to support project success and timelines. 

• Ensure compliance with process operations which interact with Good Manufacturing Practices (GMP) and regulatory guidelines. 

• Foster a culture of scientific excellence and mentor team members. 

• Stay current with industry trends and emerging technologies and regulations in cell and gene therapy analytics. 

• Support assay development activities when time allows and project priorities shift. 

• Participate in client meetings and present data, findings, risks and gaps. Collaborate with client and internal stakeholders to find and mitigate risks. 

• Ph.D. in a relevant scientific discipline (e.g., Biochemistry, Molecular Biology). 

• A minimum of 2 years of relevant experience in analytical development in the cell and gene therapy field. 

• Prior experience in cell and gene therapy or biologics assay qualification and/or validation is highly desirable. 

• Experience in assay troubleshooting, data analysis, and report writing. 

• Experience managing or leading teams in a mentor/lead capacity and/or as a manager/supervisor 

• Proficiency in a broad range of analytical techniques used in cell and gene therapies (qPCR/dPCR, Flow Cytometry, ELISA) 

• Strong communication and project management skills, with a commitment to cross functional collaboration. 

• Knowledge of cGMP and regulatory guidelines (e.g., FDA, EMA) and a track record of ensuring compliance in analytical operations. 

• Experience driving assay qualifications and validations in a phase appropriate manner. 

• Working knowledge 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. 

• Excellent verbal and written communication skills. 

• Excellent interpersonal and customer service skills. 

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.

Salary : $55 - $77