Note: The job is a remote job and is open to candidates in USA. Global Compliance Partners is seeking an Analytical Validation Consultant to support BLA activities for a gamma-retroviral vector program. The role leads analytical method development, validation, and specification justification for gene therapy products, and supports readiness of validated analytical data for BLA submission.
Responsibilities
- 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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