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. Title: Viral Vector Analytics Group Lead Position Summary 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. Key Responsibilities Technical Leadership 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. Analytical Method Qualification & Validation 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. QC Project & Technical Leadership 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. Method Transfer & External Laboratory Management 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. Risk Assessment & Gap Analysis 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. Required Qualifications 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 qualification and validation. Strong expertise in one or more viral vector platforms (AAV, lentiviral, adenoviral, etc.). Proven hands-on experience with: Infectious titer methods Genomic titer testing using ddPCR Capsid titer assays Transgene expression assays Potency assays Demonstrated experience serving as a QC technical lead and/or QC project lead. Experience leading analytical method transfers to external contract testing laboratories. Strong knowledge of GMP requirements, ICH guidelines, method validation principles, and data integrity expectations. Experience authoring and reviewing technical documents, protocols, reports, and regulatory support packages. Preferred Qualifications Prior leadership experience as QC Associate Director, Director, or equivalent. Experience supporting late-stage clinical or commercial gene therapy programs. Familiarity with regulatory inspections and agency interactions. Experience managing CDMO and contract laboratory relationships. Strong project management, communication, and stakeholder management skills. C ompensation For this contract role the hourly rate range is $75 – $110/hour based on experience. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols. #J-18808-Ljbffr Tunnell Consulting