Scientist, Downstream Process Development

Avid Bioservices•Tustin, CA

1d•$124,000 - $155,000•Onsite

About The Position

Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. The Scientist, Downstream Process Development, will support the development and optimization of downstream purification processes for protein-based biologics. Responsibilities include chromatography and filtration process development, scale-up and technology transfer activities, viral clearance studies, and data analysis. The individual will collaborate closely with Upstream Process Development, Analytical Sciences, MSAT, Manufacturing, Program Management, and clients to advance development programs from early-stage development through manufacturing.

Requirements

Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, Biological Sciences, or a related discipline with 0-3 years of relevant industry experience; OR M.S. degree with 5+ years; OR B.S. degree with 8+ years of relevant biopharmaceutical industry experience.
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.
Excellent written and verbal communication skills, with experience interacting directly with clients, partners, and senior leadership.

Nice To Haves

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 is a plus.
Experience mentoring or leading scientific staff preferred.
Experience supporting technology transfer, manufacturing process implementation, and cross-functional collaboration within a GMP-regulated environment is highly desirable.
Knowledge of process analytical technologies (PAT), laboratory automation, high-throughput process development, process intensification, and digital data management tools is preferred.
Working knowledge of regulatory expectations and CMC development activities supporting clinical and commercial biologics programs is desirable.

Responsibilities

Support the development and optimization of downstream purification processes for protein-based biologics.
Chromatography and filtration process development.
Scale-up and technology transfer activities.
Viral clearance studies.
Data analysis.
Collaborate with Upstream Process Development, Analytical Sciences, MSAT, Manufacturing, Program Management, and clients.
Advance development programs from early-stage development through manufacturing.
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.
Experience supporting technology transfer, manufacturing process implementation, and cross-functional collaboration within a GMP-regulated environment is highly desirable.
Knowledge of process analytical technologies (PAT), laboratory automation, high-throughput process development, process intensification, and digital data management tools is preferred.
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 is desirable.
Occasional travel by land and/or air may be required to attend seminars or conferences or client meetings.