Sr/Principal Scientist - Upstream Process Development

Responsibilities

• Provide technical oversight and strategic input for upstream viral vector drug substance development activities
• Lead, propose, manage, and coordinate platform improvement and continuous projects in USP labs
• Manage late-stage development including scale-down model qualification, process characterization, and validation studies
• Lead technology transfer activities at pilot plant and implement scale-up platform processes
• Provide MSAT and manufacturing technical support for troubleshooting, data analysis, and root cause analysis during GMP production
• Design experimental plans, analyze results, and maintain electronic lab notebooks (ELNs)
• Present project progress to internal cross-functional teams and external clients
• Supervise and guide a team of scientists, engineers, and technicians

Requirements

• MSc with 8+ years of relevant experience or PhD with 6+ years of relevant experience
• Background in Bioprocess Engineering, Biotechnology, Biochemistry, Protein Chemistry, or Chemical Engineering
• Experience in Process Development and Cell Line Development
• Expertise in Upstream Processing (cell culture, bioreactor technologies, transfection/infection)
• Hands-on experience with complex biologics (gene therapy, viral vaccines, or therapeutic proteins)
• Experience with technology transfer and GMP manufacturing technical support
• Knowledge of EMA/FDA regulations, ICH guidelines, and quality systems
• Proficiency in DoE design and statistical analysis
• Experience in direct management of scientists and research associates

Preferred Qualifications

• Prior work experience at a CDMO

Benefits

• Paid vacation days based on tenure
• Paid sick time
• 10 observed holidays plus 2 floating holidays and 1 volunteer day
• 401(k) plan with up to 6% company match
• Share Appreciation Rights
• Comprehensive healthcare, dental, and vision plans
• FSA and HSA programs
• Employer-paid basic term life and personal accident insurance

About the Company

Genezen provides process development, produces GMP viral vectors, and provides cell transduction for gene and cell therapy clinical trials to help lead to new cures.