Viral Vector Analytics SME

Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise.

Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.

Tunnell Consulting, looks for top consultants on behalf of our Pharmaceutical/Biotech clients. Currently, one of our client’s needs a Viral Vector Analytics Group Lead. This is a contract position. Estimated 3 month project, 40 hours/week.
All work to be completed onsite
. Our client is based in the greater Boston, MA area. Local candidates preferred.

The Viral Vector Analytics Group Lead serves as the technical lead for analytical testing strategies supporting viral vector development, qualification, validation, technology transfer, and commercial readiness. This individual provides deep expertise in analytical methods used to characterize viral vectors and plays a critical role in assay lifecycle management, QC readiness, method transfer activities, and contract laboratory oversight. The SME partners cross-functionally with Quality Control, Analytical Development, Manufacturing, Regulatory, and external testing laboratories to ensure robust, compliant, and phase-appropriate analytical programs.

• Serve as the technical SME for viral vector analytical methods across development, transfer, qualification, validation, and lifecycle management activities.
• Provide scientific leadership for analytical strategies supporting AAV, lentiviral, adenoviral, or other viral vector platforms.
• Evaluate assay performance, comparability data, and method suitability to support product development and commercialization.
• Author and review technical protocols, reports, investigations, risk assessments, validation documentation, and regulatory submissions.

• Lead and support qualification, validation, and continued performance monitoring of viral vector analytical methods.

• Demonstrated expertise with assays including:

• Infectious titer assays

• Genomic titer assays (ddPCR/qPCR)

• Capsid titer assays

• Transgene expression assays

• Potency assays

• Provide statistical and technical interpretation of qualification and validation data.

• Ensure methods meet applicable regulatory expectations and industry best practices.

• Function as a QC project lead and technical lead for analytical programs, leveraging prior experience in QC leadership roles (e.g., Associate Director, Director, or equivalent).
• Coordinate cross-functional teams to deliver analytical readiness for clinical and commercial programs.
• Lead analytical strategy discussions with internal stakeholders and external partners.
• Mentor scientists and analysts and provide technical guidance during troubleshooting and assay optimization efforts.

• Lead planning, execution, and oversight of analytical method transfers to contract testing laboratories (CTLs/CDMOs).
• Develop transfer strategies, protocols, acceptance criteria, and execution plans.
• Manage interactions with external testing partners to ensure successful implementation and sustained method performance.
• Review transfer data packages and drive resolution of technical issues and deviations.

• Lead cross-functional gap assessments and risk evaluations related to analytical methods, QC operations, and testing networks.
• Identify technical, regulatory, compliance, and operational risks and develop mitigation plans.
• Support inspection readiness and responses related to analytical testing and laboratory operations.
• Drive continuous improvement initiatives to strengthen analytical capabilities and QC processes.

• Advanced degree (MS or PhD preferred) in Biology, Molecular Biology, Virology, Biochemistry, Biotechnology, or related scientific discipline.

• Minimum 8-15 years of biopharmaceutical industry experience, including significant experience supporting viral vector analytics.

• Extensive experience with analytical method…