Global Compliance Partners

Global Compliance Partners (GCP) is a biotech consulting firm specializing in comprehensive quality and technical solutions for the biotech and life sciences industries. Founded by experts with deep…

BiotechCell TherapyConsultingData IntegrityGene TherapyLife SciencesQuality AssuranceValidationglobalcompliancepartners.com

Global Compliance Partners

BiotechCell TherapyConsultingData IntegrityGene TherapyLife SciencesQuality AssuranceValidationglobalcompliancepartners.com

HQSeattle, US

Team Size10

Open JobsUnknown

Total Funding-

Latest FundraiseUnknown

Join the Team

Analytical Validation Consultant - Vector programs

RemoteUS

Remote • US

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:

BLA Section 3.2.S.4.3 – Validation of Analytical Procedures

BLA Section 3.2.S.4.4 – Specifications and Testing

Develop and justify specifications for gamma-retroviral vector release and stability .
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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Author 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: Vector particle titer, infectious unit quantification, and transduction efficiency assays.

Potency: Cell-based infectivity or transgene expression assays confirming biological activity.

Impurities: Residual host cell DNA, host cell proteins, process-related impurities (e.g., Benzonase, plasmid DNA, serum proteins).

Safety: Sterility, mycoplasma, endotoxin, and replication-competent retrovirus (RCR) testing.

Identity: qPCR or ddPCR-based vector genome detection, envelope gene assays, or capsid protein identity.

Ensure all methods follow validated lifecycle approaches and comply with 21 CFR Part 211 , USP <1033> , and ICH Q2(R2) .