Downstream Bioprocess Associate - Purification (GMP)

Bora Biologics; San Diego (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

Bora Biologics in California seeks a Manufacturing Associate II, Downstream, to perform routine GMP downstream manufacturing tasks. You will operate chromatography, UF/DF, and viral filtration skids, and maintain detailed batch records in a cleanroom environment.

The role requires following SOPs, GDP and cGMP guidelines, and collaborating with cross-functional teams to meet project milestones. Overtime may be required as needed.

Qualifications

• Advanced degree or BS+experience in pharma/biotech adaptable to GMP
• Hands-on downstream purification and bioprocessing workflows
• Proficient in documentation per GDP and batch records

Responsibilities

• Perform GMP downstream manufacturing activities in assigned areas.
• Set up, operate, maintain and clean chromatographic systems, UF/DF, viral filtration skids, and mixers.
• Complete batch records and revise SOPs as needed.
• Follow GDP and cGMP guidelines to ensure product quality.

Skills

Downstream Purification

Protein Chromatography

TFF

Depth Filtration

Viral Filtration

Bulk Drug Formulation

Aseptic Sampling

Microsoft Word

Microsoft Excel

Education

Advanced life sciences degree

Bachelor's degree + biotech experience

HS diploma + biotech experience

Job description

Bora Biologics in California seeks a Manufacturing Associate II, Downstream, to perform routine GMP downstream manufacturing tasks. You will operate chromatography, UF/DF, and viral filtration skids, and maintain detailed batch records in a cleanroom environment.

The role requires following SOPs, GDP and cGMP guidelines, and collaborating with cross-functional teams to meet project milestones. Overtime may be required as needed.