Senior Downstream Bioprocess Engineer Early Phase

Avid Bioservices, Inc.; Costa Mesa (CA); Presencial; USD 32.000 - 40.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health Insurance

Dental Insurance

Vision Insurance

401(k) Matching

Paid Time Off

Descripción de la vacante

Avid Bioservices, Inc. in California seeks a Sr. Manufacturing Associate - Downstream to drive virus purification and filtration in a GMP biopharma facility. You will execute downstream operations, ensure aseptic technique, and support production schedules.

You will mentor junior staff, maintain cleanrooms, and contribute to batch records, SOPs, and continuous improvement while adhering to GMP and regulatory standards. This role offers competitive compensation and comprehensive benefits.

Formación

• BS in Biotechnology, Biology, Chemistry or equivalent.
• 2+ years GMP biologics manufacturing, downstream experience essential.
• Aseptic practices and clean room operations required.
• Knowledge of GMP, FDA/EMA regulations for biologics.

Responsabilidades

• Prioritize and execute the daily manufacturing schedule for downstream operations.
• Troubleshoot equipment and processes with M.S. & Tech.
• Perform osmolality, pH, conductivity tests and filter integrity checks.
• Maintain clear communication with management across functions.
• Train junior manufacturing associates.
• Ensure timely setup of equipment and materials for each run.
• Plan and prepare resources for processes and activities.
• Maintain cleanrooms to be audit-ready and inventory for manufacturing.
• Draft and revise Batch Production Records and SOPs as needed.
• Demonstrate strong technical writing for deviations and reports.

Conocimientos

GMP Manufacturing

Downstream Processing

Aseptic Techniques

Troubleshooting

Equipment Setup

Batch Records

Mentoring

Documentation

Educación

BS in Biotechnology/Biology/Chemistry

Herramientas

Process Knowledge

Descripción del empleo

Avid Bioservices, Inc. in California seeks a Sr. Manufacturing Associate - Downstream to drive virus purification and filtration in a GMP biopharma facility. You will execute downstream operations, ensure aseptic technique, and support production schedules.

You will mentor junior staff, maintain cleanrooms, and contribute to batch records, SOPs, and continuous improvement while adhering to GMP and regulatory standards. This role offers competitive compensation and comprehensive benefits.