Analytical Validation Consultant - Vector programs
Global Compliance Partners
Job Description
Overview:
\nGlobal 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.
\n \nScope of Work:
\n- \n
- Author/Review the Analytical Method Validation Master Plan (AMVMP) specific to the gamma-retroviral vector platform. \n
- Design and execute validation strategies for analytical methods supporting vector release, stability, and comparability. \n
- Oversee method development and validation for Strength, potency, impurities, safety and identity assays.: \n
- Develop and justify specifications for gamma-retroviral vector release and stability. \n
- Collaborate with Vector CDMOs for Sample traceability matrices and sampling logistics. \n
- Author the Specification Justification Report for Vector, summarizing analytical data and rationale for acceptance criteria. \n
- Support readiness assessments for inclusion of validated analytical data in the BLA submission. \n
Vacancy posted 6 days ago
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