Manufacturing Associate III, Downstream

Avid Bioservices•Tustin, CA

4d•Onsite

About The Position

Avid Bioservices is seeking a Manufacturing Associate III to support downstream manufacturing in its viral vector facility. The role executes complex virus purification and filtration activities in a fast-paced, GMP-regulated biopharmaceutical manufacturing operation, including harvest, clarification, tangential flow filtration (TFF), chromatography, other filtration techniques, and product filling. The associate helps meet production schedules, prepares equipment, materials, media, and buffer solutions, conducts analytical and filter-integrity tests, troubleshoots processes and equipment, and maintains cleanroom readiness and material inventory. The position also requires communicating manufacturing issues and observations, training junior associates, maintaining compliant manufacturing documentation, and contributing to continuous improvement. Work is in Tustin, California, Monday through Friday from 8:00 a.m. to 5:00 p.m., unless otherwise stated by the Supervisor. Flexibility to work overtime, weekends, and holidays when needed is required.

Requirements

At least 2 years of experience in GMP biologics manufacturing.
Previous downstream process experience.
Advanced knowledge of aseptic practices and cleanroom operations.
Advanced knowledge of GMP and FDA and EMA regulatory requirements applicable to biologics, including gene and viral therapy products, with a focus on downstream operations.
Advanced knowledge of manufacturing processes and understanding of, or ability to use, the latest technologies.
Proven logic and decision-making abilities and critical-thinking skills.
Ability to work overtime, weekends, and/or holidays when necessary.
Strong written and verbal communication skills.
Exceptional multitasking and attention to detail.
Ability to build relationships with team members, clients, vendors, and suppliers.
Ability to perform job activities involving sitting, standing, walking, and occasional lifting of objects up to 20 pounds.
Visual acuity, including close, distance, and color vision.

Nice To Haves

A bachelor's degree in biotechnology, biology, chemistry, or an equivalent field is preferred.
Biochemistry or biology as an area of study is preferred.

Responsibilities

Support manufacturing schedule prioritization and execute the daily manufacturing schedule.
Perform downstream virus manufacturing processes, including harvest, clarification, TFF and chromatography purification, filtration, and product filling.
Troubleshoot equipment and processes in partnership with the Manufacturing Science and Technology department.
Conduct analytical tests such as osmolality, pH, and conductivity, as well as filter-integrity testing.
Communicate problems and observations clearly to management and other departments.
Train junior-level manufacturing associates.
Set up equipment and materials in a timely manner for production runs.
Plan and prepare resources for manufacturing processes and activities.
Assist in other production areas as needed.
Use precise aseptic techniques.
Keep cleanrooms clean, organized, maintained, and audit ready.
Maintain department inventory, kit materials for upcoming cleanroom operations, and organize materials for manufacturing processes.
Follow GMP documentation standards and initiate or revise batch production records, standard operating procedures, study protocols, and reports.
Prepare technical documents such as deviations, SOPs, logbooks, work instructions, and forms.
Prepare media and buffer solutions for production processes.
Adhere to cGMP and/or ISO standards when manufacturing bulk drug products, final drug substances, and research products.
Take ownership of work quality and promptly notify responsible management of regulatory inspections, serious GMP deficiencies, process deviations, product defects, and related actions.
Attend meetings and participate in continuous improvement projects.