Senior Downstream Bioprocess Specialist (GMP)

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

Benefits offered by this job

Health, dental and vision insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices in Costa Mesa, CA seeks a Sr. Manufacturing Associate - Downstream to lead virus purification and filtration in a state-of-the-art facility.

You will work under GMP standards, perform analytical tests, and help ensure timely production of biologics with a focus on aseptic techniques and accurate documentation. The role requires 2+ years in GMP biologics downstream, a BS degree, and a readiness to mentor junior staff while complying with regulatory standards.

Qualifications

• BS in Biotechnology, Biology, Chemistry or equivalent, preferred biochemistry/biology focus.
• 2+ years of GMP biologics downstream experience.
• Aseptic practices and clean room operations.
• Knowledge of GMP, FDA and EMA requirements for biologics.
• Familiarity with downstream processes and latest technologies.

Responsibilities

• Prioritize and execute daily manufacturing schedules for downstream operations.
• Troubleshoot equipment and processes in collaboration with MS&T.
• Conduct osmolality, pH, conductivity and filter integrity tests.
• Train junior manufacturing associates.
• Ensure setup and readiness of equipment for production runs.
• Maintain cleanrooms, inventory, and GMP documentation.

Skills

GMP manufacturing

Aseptic techniques

Process troubleshooting

Analytical testing

Strong communication

Education

Bachelor's degree in Biotechnology or related

Job description

Avid Bioservices in Costa Mesa, CA seeks a Sr. Manufacturing Associate - Downstream to lead virus purification and filtration in a state-of-the-art facility.

You will work under GMP standards, perform analytical tests, and help ensure timely production of biologics with a focus on aseptic techniques and accurate documentation. The role requires 2+ years in GMP biologics downstream, a BS degree, and a readiness to mentor junior staff while complying with regulatory standards.