Viral Vector Analytics SME
About The Position
Tunnell Consulting is seeking a Viral Vector Analytics Group Lead on behalf of their Pharmaceutical/Biotech clients. This is a contract position estimated for 3 months, requiring 40 hours per week, all to be completed onsite in the greater Boston, MA area. The role serves as the technical lead for analytical testing strategies supporting viral vector development, qualification, validation, technology transfer, and commercial readiness. The individual will provide deep expertise in analytical methods for viral vector characterization and will be critical in assay lifecycle management, QC readiness, method transfer activities, and contract laboratory oversight. This role requires cross-functional partnership with Quality Control, Analytical Development, Manufacturing, Regulatory, and external testing laboratories to ensure robust, compliant, and phase-appropriate analytical programs.
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.
Nice To Haves
- 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.
Responsibilities
- 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.
- 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.
Benefits
- Hourly rate range of $75 - $110/hour based on experience.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
