Analytical Validation Consultant - Vector programs

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.