Downstream Pilot Plant Associate – Gene Therapy

Stark Pharma Solutions Inc; San Diego (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

Stark Pharma Solutions Inc. seeks a Downstream Pilot Plant Associate to join our Manufacturing team. The role focuses on executing downstream purification processes for gene therapy product manufacturing, maintaining GLP/GMP documentation, and supporting continuous improvement initiatives on the floor.

Ideal candidates hold a B.S. in Biology with 4–6 years of process development experience and hands-on chromatography, ultrafiltration, and depth filtration.

Qualifications

• B.S. degree in Biology or related field plus 4–6 years of process development experience.
• Hands-on chromatography, ultrafiltration and depth filtration at lab, pilot or production scale.
• Strong working knowledge of cGMP and GDP with documentation practices.

Responsibilities

• Perform downstream purification processes including chromatography, ultrafiltration, TFF, and depth filtration at pilot and production scales.
• Operate and maintain bioprocessing equipment and document batch records, SOPs, and tech transfer documents.
• Support investigations, root cause analysis, and process troubleshooting in collaboration with cross-functional teams.
• Ensure compliance with SOPs, training requirements, and scale-up best practices.

Skills

Chromatography

Ultrafiltration

Depth filtration

cGMP

GDP

Process development

Technical writing

Cross-functional collaboration

Education

B.S. in Biology

Tools

ERP platforms

Job description

Stark Pharma Solutions Inc. seeks a Downstream Pilot Plant Associate to join our Manufacturing team. The role focuses on executing downstream purification processes for gene therapy product manufacturing, maintaining GLP/GMP documentation, and supporting continuous improvement initiatives on the floor.

Ideal candidates hold a B.S. in Biology with 4–6 years of process development experience and hands-on chromatography, ultrafiltration, and depth filtration.