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 of 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 greater Philadelphia area, we also have a presence in Washington DC and Boston.

About the Role

We are seeking a Viral Vector Analytics Group Lead for a contract position with one of our Pharmaceutical/Biotech clients. This is an estimated 3-month project requiring 40 hours per week, with all work to be completed onsite at our client’s location in the greater Boston, MA area. Local candidates are preferred.

Responsibilities

• Technical Leadership
  • Serve as the technical subject matter expert (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.
  • Demonstrate 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.

Requirements

• 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.

Pay

For this contract role, the hourly rate range is $75 - $110/hour based on experience.