Analytical Validation Consultant - Vector programs
Global Compliance Partners
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.
Skills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today.
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. xhyhwjd
- Support readiness assessments for inclusion of validated analytical data in the BLA submission.
Vacancy posted 10 hours ago
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