Scientist, Downstream Process Development
$124,000–$155,000 year
On-siteTustin, California, United States
Job Summary
Conduct chromatography and filtration process development, scale-up, and technology transfer for protein-based biologics while leading technical projects and troubleshooting complex process challenges. Analyze and interpret scientific data to advance development programs from early-stage to manufacturing, author technical reports, and communicate findings to internal stakeholders and clients. Collaborate with Upstream Process Development, Analytical Sciences, and cross-functional teams within a GMP-regulated environment to optimize downstream purification processes. Occasional travel is required for seminars, conferences, or client meetings.
Required Qualifications
- Demonstrated expertise in downstream process development for monoclonal antibodies, recombinant proteins, and other biologic modalities, including chromatography, filtration, buffer development, and process scale-up
- Strong understanding of protein purification principles, process characterization, experimental design, statistical data analysis, and biopharmaceutical development workflows
- Experience leading technical projects, troubleshooting complex process challenges, and driving development strategies with minimal supervision
- Demonstrated ability to analyze, interpret, and present scientific data, author technical reports, and communicate findings effectively to internal and external stakeholders
- Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, Biological Sciences, or a related discipline with 0-3 years of relevant industry experience
- M.S. degree with 5+ years of relevant industry experience
- B.S. degree with 8+ years of relevant biopharmaceutical industry experience
- Ability to work overtime and/or weekends when necessary
Desired Qualifications
- Experience supporting technology transfer, manufacturing process implementation, and cross-functional collaboration within a GMP-regulated environment
- Knowledge of process analytical technologies (PAT), laboratory automation, high-throughput process development, process intensification, and digital data management tools
- Proven ability to mentor junior scientists and provide scientific leadership across project teams
- Excellent written and verbal communication skills, with experience interacting directly with clients, partners, and senior leadership
- Working knowledge of regulatory expectations and CMC development activities supporting clinical and commercial biologics programs
- Occasional travel by land and/or air to attend seminars or conferences or client meetings
- Ph.D. in Biochemistry, Chemistry, or related field with 1-2 years or M.S. with 3-5 years of industry experience
- Prior experience in leading downstream process development of biologics
- Experience mentoring or leading scientific staff
- You have a 'bring it on!' team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers
- Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.