Scientist, Downstream Process Development

Avid Bioservices•Tustin, CA

5d•Onsite

About The Position

Avid Bioservices is seeking a Scientist, Downstream Process Development to support the development and optimization of downstream purification processes for protein-based biologics. This role involves chromatography and filtration process development, scale-up and technology transfer activities, viral clearance studies, and data analysis. The scientist will collaborate closely with various departments including 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.
Excellent written and verbal communication skills.
Ability to work overtime and/or weekends when necessary.

Nice To Haves

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.
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.
Team player approach and an unshakable positive attitude.
Exceptional multitasking skills and an unparalleled attention to detail.
Mastery at building relationships, capable of establishing connections with anyone.
Visual acuity, including close, distance, and color vision.

Responsibilities

Support the development and optimization of downstream purification processes for protein-based biologics.
Conduct chromatography and filtration process development.
Perform scale-up and technology transfer activities.
Execute viral clearance studies.
Analyze and interpret scientific data.
Collaborate with Upstream Process Development, Analytical Sciences, MSAT, Manufacturing, Program Management, and clients.
Advance development programs from early-stage development through manufacturing.
Lead technical projects.
Troubleshoot complex process challenges.
Drive development strategies with minimal supervision.
Author technical reports.
Present findings effectively to internal and external stakeholders.
Support technology transfer and manufacturing process implementation.
Engage in cross-functional collaboration within a GMP-regulated environment.
Mentor junior scientists and provide scientific leadership.
Interact directly with clients, partners, and senior leadership.
Support CMC development activities for clinical and commercial biologics programs.