Analytical Validation Consultant - Vector programs
Posted 3 days ago
global compliance partnersDenver (CO)
SENIORITY
Lead
About the role
Overview:
Global Compliance Partners is seeking an experienced Analytical Validation Consultant to support BLA (Biologics License Application) activities for a gamma-retroviral vector program. The consultant will lead analytical method development, validation, and specification justification efforts aligned with ICH Q2(R2), Q14, and relevant FDA/EMA expectations for gene therapy products. Scope of Work: Author/Review the Analytical Method Validation Master Plan (AMVMP) specific to the gamma-retroviral vector platform. Design and execute validation strategies for analytical methods supporting vector release, stability, and comparability. Oversee method development and validation for Strength, potency, impurities, safety and identity assays.:Develop and justify specifications for gamma-retroviral vector release and stability. Collaborate with Vector CDMOs for Sample traceability matrices and sampling logistics. Author the Specification Justification Report for Vector, summarizing analytical data and rationale for acceptance criteria. Support readiness assessments for inclusion of validated analytical data in the BLA submission.
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