Senior Downstream Biopharma Manufacturing Specialist

avidbio; Costa Mesa (CA); On-site; USD 66,000 - 88,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices in Costa Mesa, CA seeks a Sr. Manufacturing Associate - Downstream to drive virus purification operations in a GMP-biologics facility. You will execute the daily manufacturing schedule, ensure aseptic practices, and mentor junior staff while upholding FDA/EMA regulatory standards.

Responsibilities include virus purification, analytics, equipment troubleshooting, and maintaining audit-ready cleanrooms. Strong teamwork and attention to detail are essential for success in this role.

Qualifications

• BS in Biotechnology, Biology, Chemistry or equivalent required.
• 2+ years of GMP manufacturing experience in biologics, downstream process essential.
• Aseptic practices and clean room operations.
• Advanced knowledge of GMP, FDA and EMA regulations applicable to Biologics.

Responsibilities

• Prioritize and execute daily manufacturing schedule for virus purification techniques (Harvest, Clarification, Purification by TFF/Chromatography) and filtration.
• Troubleshoot equipment and processes with Manufacturing Science and Technology teams.
• Conduct analytical tests (osmolality, pH, conductivity) and perform filter integrity testing.
• Train junior manufacturing associates and ensure equipment/material readiness for production runs.
• Maintain cleanrooms, inventory, and GMP documentation; support continuous improvement initiatives.

Skills

GMP manufacturing

Downstream processing

Aseptic techniques

Regulatory knowledge

Education

BS in Biotechnology/Biology/Chemistry

Job description

Avid Bioservices in Costa Mesa, CA seeks a Sr. Manufacturing Associate - Downstream to drive virus purification operations in a GMP-biologics facility. You will execute the daily manufacturing schedule, ensure aseptic practices, and mentor junior staff while upholding FDA/EMA regulatory standards.

Responsibilities include virus purification, analytics, equipment troubleshooting, and maintaining audit-ready cleanrooms. Strong teamwork and attention to detail are essential for success in this role.