Downstream Process Development & Tech Transfer Expert

Bioethic Consulting LLC; San Carlos (CA); On-site; USD 103,000 - 124,000; Full time

Job summary

Viltis is seeking an experienced Downstream Process Development / Tech Transfer Consultant to support a biotechnology client in San Carlos, CA. This contract position focuses on downstream process development, pilot plant execution, scale-up, and technology transfer activities.

You will own key downstream workstreams, lead technical execution with external CMO/CDMO partners, and collaborate with cross-functional teams to ensure successful program objectives and manufacturing readiness.

Qualifications

• 10+ years of experience in biopharmaceutical process development (downstream)
• Strong expertise in downstream process development and scale-up
• Experience with technology transfer to manufacturing facilities and/or CMOs/CDMOs
• Hands-on experience with membrane filtration and tangential flow filtration (TFF)
• Experience supporting pilot-scale or manufacturing-scale downstream operations
• Strong understanding of downstream process parameters, process characterization, troubleshooting, and scale-up considerations
• Ability to independently lead technical workstreams while collaborating across teams
• Strong technical communication, documentation, problem-solving, and stakeholder management

Responsibilities

• Support downstream process development, optimization, scale-up, and technology transfer activities.
• Lead significant portions of downstream technical execution with external CMO/CDMO partners.
• Support pilot plant and on-site scale-up activities, including execution, troubleshooting, and process evaluation.
• Provide technical leadership for downstream unit operations, including membrane filtration and TFF.
• Develop, review, and support technical documentation for process development and technology transfer.
• Evaluate process performance, identify risks, and recommend solutions during scale-up and manufacturing transfer.
• Collaborate with Process Development, Manufacturing, Quality, Regulatory, and other teams to ensure program objectives.

Skills

Downstream process development

Scale-up

Technology transfer

Membrane filtration / TFF

Pilot scale

Process characterization

Technical leadership

Communication / documentation

GMP experience

Product launch readiness

Job description

Viltis is seeking an experienced Downstream Process Development / Tech Transfer Consultant to support a biotechnology client in San Carlos, CA. This contract position focuses on downstream process development, pilot plant execution, scale-up, and technology transfer activities.

You will own key downstream workstreams, lead technical execution with external CMO/CDMO partners, and collaborate with cross-functional teams to ensure successful program objectives and manufacturing readiness.