Scientist Ii/Senior Scientist, Analytical Development

Responsibilities

• Execute development, optimization and troubleshooting of analytical methods for cell and gene therapy products, ensuring technical excellence.
• Execute routine testing activities, including in-process recoveries, stability studies, and cell line characterization.
• Evaluate new and innovative technologies for implementation into QC.
• Partner with MSAT on process characterization and control strategies.
• Lead assay transfer to quality control team, including writing SOPs and training QC analysts.
• Take a lead role in assay qualification activities, including partnering with QC, planning qualifications, data analysis and interpretation.
• Write qualification protocols and qualification reports in accordance to regulatory guidelines.
• Implement statistical tools and design of experiments (DOE) to ensure robustness and reliability of assays.
• Provide technical expertise and support 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 scientists, engineers, 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 in cell and gene therapy analytics.

Requirements

• Ph.D. in a relevant scientific discipline (e.g., Biochemistry, Molecular Biology).
• A minimum of 2 years of relevant experience in Analytical Development and testing in the cell and gene therapy field.
• 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, HPLC)
• Extensive flow cytometry experience is strongly preferred.
• 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.
• 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.

Salary and Benefits

• The base salary range for this role is $115,000 - $160,000; starting pay is determined by multiple job-related factors including a candidate’s skills, education and experience level, benchmark, and internal parity.
• We offer an excellent benefits program including a selection of Medical, Dental and Vision plans, FSA, HSA, Company paid holidays, employee assistance program, commuter benefits, wellbeing resources, perks and more!
• Significant growth opportunity as the company expands.