SciPro is working with a global biotech, developing advanced cell therapies across a variety of platforms. This organization is seeking a Principal Scientist to work on Lentivirus, Downstream Process development.

This person will be responsible for designing and scaling purification processes for lentiviral vectors. They will focus on delivering vector products to support LVV generation and other advanced cell tx programs. We're looking for a candidate with excellent scientific experience in downstream process development to ensure robust, saleable and phase appropriate processes for GMP manufacturing.

Responsibilities:

• Design and execute purification strategies optimized for CAR-T applications
• Direct the development and optimization of downstream processes (clarification, chromatography, TFF)
• Direct translation of bench-scale processes to GMP manufacturing
• lead the execution of study protocols to define operating parameters and performance limits
• provide hands-on training where needed
• communicate potential issues or delays along with solutions or ways to address
• leverage advanced techniques and tech to maximize recovery, purity, and potency
• oversee a team in the execution of project-specific activities
• author and review technical documents (SOPs, Dev Reports, and CMC Sections for Regulatory Submissions)
• Tech Transfer process to/from other sites or CDMOs

Requirements:

• Advanced Degree (PhD or MS) in Chemical Engineering, Biomedical Engineering, Virology, or Molecular Biology
• 8+ years of experience in PD or Manufacturing within biotech setting
• Technical, hands-on experience in purification, chromatography, and TFF for viral vectors (ideally lentivirus specifically)
• Understanding of GMP manufacturing requirements and CMC strategies for early-phase trials
• Ability to implement closed-system processes
• Leadership, creative thinking, and troubleshooting skills
• Ideally with experience in developing vector processes for CAR-T generation and delivery
• Ideally with experience in handling large scale purification process

Logistics:

• This role is 5-days/week onsite in Somerset, NJ
• Annual Salary Range: $150,000-$180,000