Viral Vector Analytics Group Lead - Contract Boston MA
Overview
Tunnell Consulting seeks a Viral Vector Analytics Group Lead to lead analytical testing strategies for viral vector development and commercial readiness. This contract role involves 40 hours per week onsite in Boston area. The ideal candidate will own assay development and lead cross-functional teams to ensure robust compliant analytical programs.
What You'll Do11
- 1Serve as technical SME for viral vector analytical methods across development transfer qualification validation and lifecycle management activities
- 2Provide scientific leadership for analytical strategies supporting AAV lentiviral adenoviral or other viral vector platforms
- 3Evaluate assay performance comparability data and method suitability to support product development and commercialization
- 4Author and review technical protocols reports investigations risk assessments validation documentation and regulatory submissions
- 5Lead qualification validation and continued performance monitoring of viral vector analytical methods
- 6Function as QC project lead coordinating cross-functional teams to deliver analytical readiness for clinical and commercial programs
- 7Coordinate external laboratory management for method transfers to contract testing laboratories
- 8Perform cross-functional gap assessments and risk evaluations related to analytical methods QC operations and testing networks
- 9Drive continuous improvement initiatives to strengthen analytical capabilities and QC processes
- 10Mentor scientists and analysts providing technical guidance during troubleshooting and assay optimization
- 11Support inspection readiness and manage stakeholder communications regarding analytical testing and laboratory operations
Requirements13
- 15+ years building ETL pipelines with Spark and Airflow
- 2Advanced degree in Biology Molecular Biology Virology Biochemistry Biotechnology or related field
- 38-15 years of biopharmaceutical industry experience supporting viral vector analytics
- 4Extensive experience with infectious titer methods genomic titer testing using ddPCR capsid titer assays transgene expression assays potency assays
- 5Proven experience serving as a QC technical lead or QC project lead
- 6Experience leading analytical method transfers to external contract testing laboratories
- 7Strong knowledge of GMP requirements ICH guidelines method validation principles and data integrity expectations
- 8Experience authoring and reviewing technical documents protocols reports and regulatory support packages
- 9Prior leadership as QC Associate Director Director or equivalent
- 10Experience supporting late-stage clinical or commercial gene therapy programs
- 11Familiarity with regulatory inspections and agency interactions
- 12Experience managing CDMO and contract laboratory relationships
- 13Strong project management communication and stakeholder management skills
Salary Insight
$75 - $110k per year
Location
Required Skills
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