Downstream Process Development Scientist / Tech Transfer Consultant

Employment Type: Contract
Compensation: $75–$90/hour, depending on experience and technical background.
Function: Process Development / Manufacturing Sciences / Technology Transfer
Reporting To: Associate Director
Industry: Biotechnology / Biopharmaceutical Manufacturing

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 contract position will work as part of an established process development team and report to an Associate Director. The consultant will take ownership of key downstream technical workstreams while partnering closely with internal cross-functional teams and external CMO/CDMO manufacturing partners.

Key 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.

Required Qualifications

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.

About Viltis

Viltis provides specialized consulting and workforce solutions to organizations across the biotechnology, pharmaceutical, medical device, and life sciences industries. We connect experienced technical professionals with projects where their expertise can make an immediate impact.

Candidates with deep downstream process development experience who have supported scale-up, technology transfer, PPQ, and commercial launch activities are encouraged to apply.

Bioethic Consulting LLC

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Downstream Process Development / Tech Transfer Consultant