Gene Therapy Downstream Manufacturing Specialist

WhiteCap Search; San Diego (CA); On-site; USD 55,000 - 83,000; Full time

Job summary

WhiteCap Search is seeking a hands-on specialist to support technical operations and manufacturing activities for gene therapy programs in a pilot/manufacturing environment in San Diego, CA. The role emphasizes downstream purification, equipment operation, batch records, and compliance with cGMP practices.

The ideal candidate brings 4 years' bioprocessing experience, working on chromatography, TFF, and depth filtration, with strong documentation and cross-functional teamwork abilities in a

Qualifications

• Bachelor's degree in biology, biochemistry, biotechnology, chemical engineering or related field.
• Approximately 4 years of experience in bioprocessing, biologics manufacturing, or related environment.
• Hands-on downstream processing experience including chromatography, ultrafiltration/TFF, and depth filtration.
• GMP-regulated environment and good documentation practices.

Responsibilities

• Execute downstream purification processes at lab, pilot, and manufacturing scale.
• Operate and maintain bioprocessing equipment used in downstream manufacturing.
• Prepare and maintain batch records, SOPs, and other manufacturing documentation.
• Support technology transfer and scale-up activities as programs progress.
• Collaborate with cross-functional teams on deviations, investigations, and corrective actions.
• Identify opportunities for process and operational improvements.
• Maintain a safe, compliant manufacturing environment.
• Document manufacturing activities using electronic systems.
• Serve as a technical resource for manufacturing processes and deliverables.
• May lead specific manufacturing operations on the floor.

Skills

Bioprocessing

Downstream purification

GMP compliance

Documentation practices

Cross-functional teamwork

Technical writing

Education

Bachelor's degree in Biology/Biochemistry/Biotechnology/Chemical Engineering

Tools

Chromatography

Ultrafiltration/TFF

Depth filtration

Job description

WhiteCap Search is seeking a hands-on specialist to support technical operations and manufacturing activities for gene therapy programs in a pilot/manufacturing environment in San Diego, CA. The role emphasizes downstream purification, equipment operation, batch records, and compliance with cGMP practices.

The ideal candidate brings 4 years' bioprocessing experience, working on chromatography, TFF, and depth filtration, with strong documentation and cross-functional teamwork abilities in a