Downstream Process Development / Tech Transfer Consultant

Contract position in San Carlos, California, reporting to an Associate Director in the biotechnology/biopharmaceutical manufacturing industry.

About the role

Viltis is seeking an experienced Downstream Process Development / Tech Transfer Consultant to support a biotechnology client with downstream process development, pilot plant execution, scale-up, and technology transfer activities. This consultant will work as part of an established process development team, taking ownership of key downstream technical workstreams while partnering closely with internal cross-functional teams and external CMO/CDMO manufacturing partners.

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 tangential flow filtration (TFF).
• Develop, review, and support technical documentation associated with process development and technology transfer.
• Evaluate process performance, identify technical risks, and recommend appropriate solutions during scale-up and manufacturing transfer.
• Partner with Process Development, Manufacturing, Quality, Regulatory, and other cross-functional groups to ensure successful execution of program objectives.
• Support activities associated with Process Performance Qualification (PPQ) campaigns.
• Contribute to commercial manufacturing readiness and product launch activities.
• Participate in technical discussions, investigations, troubleshooting, and decision-making with internal teams and external manufacturing partners.
• Ensure downstream processes are appropriately transferred, understood, and executable at the receiving manufacturing site.
• Operate effectively within a broader technical team while independently owning assigned downstream workstreams.

Requirements

• 10+ years of experience in biopharmaceutical process development, with substantial experience focused on downstream processing.
• Strong technical expertise in downstream process development and scale-up.
• Demonstrated experience with technology transfer to manufacturing facilities and/or CMO/CDMO partners.
• 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 effectively within a multidisciplinary team.
• Strong technical communication, documentation, problem-solving, and stakeholder-management skills.

Preferred Qualifications

• Experience supporting PPQ campaigns.
• Experience supporting commercial product launches or commercial manufacturing readiness.
• Previous experience working directly with CMOs/CDMOs on process transfer and manufacturing execution.
• Experience supporting biologics manufacturing in a regulated GMP environment.
• Experience transitioning processes from development through clinical and commercial manufacturing.

Pay

$75–$90/hour, depending on experience and technical background.