Manufacturing Associate III, Downstream

Avid Bioservices•Tustin, CA

1d•$22 - $28•Onsite

About The Position

Avid Bioservices is seeking a Manufacturing Associate III - Downstream to support production in its viral vector facility. The role executes complex virus purification and filtration activities in a fast-paced biopharmaceutical manufacturing operation, with responsibility for producing high-quality products under GMP requirements. The associate also troubleshoots processes and equipment, performs analytical testing, prepares production resources, and helps train junior manufacturing associates. The position supports daily manufacturing schedules and requires strong aseptic practices, cleanroom readiness, inventory management, technical documentation, and preparation of media and buffer solutions. The associate works with Manufacturing Science and Technology and other departments, communicates issues and observations to management, and contributes to continuous improvement.

Requirements

At least 2 years of experience in GMP biologics manufacturing.
Essential prior experience in downstream processing.
Strong logic, decision-making, and critical-thinking skills.
Aseptic practices and cleanroom operations knowledge.
Advanced knowledge of GMP, 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, current technologies.
Ability to work flexibly overtime, weekends, and/or holidays when necessary.
Strong written and verbal communication skills, multitasking ability, attention to detail, and relationship-building skills.

Nice To Haves

Bachelor of Science in Biotechnology, Biology, Chemistry, or an equivalent field; biochemistry or biology is the preferred area of study.

Responsibilities

Support manufacturing schedule prioritization and execute the daily schedule, 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 manufacturing and other department management.
Train junior-level manufacturing associates.
Set up equipment and materials in a timely manner for each production run.
Plan and prepare resources for processes and activities.
Assist in other production areas as needed.
Use exceptional aseptic techniques and precise, deliberate movements.
Keep cleanrooms clean, organized, maintained, and audit ready; maintain department inventory and kit materials for upcoming cleanroom operations.
Plan, organize, and maintain material inventory for manufacturing processes.
Comply with GMP documentation standards.
Initiate and revise Batch Production Records, Standard Operating Procedures, study protocols, and reports.
Attend meetings and participate in continuous improvement projects.
Create and maintain technical documents, including deviation initiations, SOPs, logbooks, working instructions, and forms.
Prepare media and buffer solutions for production processes.
Comply with cGMP and/or ISO standards during manufacture of bulk drug products, final drug substances, and research products.
Own the quality of deliverables and promptly notify responsible management of regulatory inspections, serious GMP deficiencies, process deviations, product defects, and related actions.