Global Compliance Partners · 16 hours ago
Analytical Validation Consultant - Vector programs
United States
Contract
Remote
Senior LevelGlobal Compliance Partners is seeking an experienced Analytical Validation Consultant to support BLA activities for a gamma-retroviral vector program. The consultant will lead analytical method development, validation, and specification justification efforts aligned with ICH Q2(R2) and relevant FDA/EMA expectations for gene therapy products.
AdviceInformation ServicesManagement ConsultingRisk Management
Hiring Manager
Apurva Shah
Responsibilities
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)
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
Qualification
Required
Experience in analytical method development and validation for gene therapy products
Knowledge of ICH Q2(R2), Q14, and relevant FDA/EMA expectations
Ability to author Analytical Method Validation Master Plan (AMVMP)
Experience in designing and executing validation strategies for analytical methods
Experience in overseeing method development and validation for vector release, stability, and comparability
Knowledge of strength assays including vector particle titer, infectious unit quantification, and transduction efficiency assays
Knowledge of potency assays including cell-based infectivity or transgene expression assays
Knowledge of impurities testing including residual host cell DNA, host cell proteins, and process-related impurities
Knowledge of safety testing including sterility, mycoplasma, endotoxin, and replication-competent retrovirus (RCR) testing
Knowledge of identity testing including qPCR or ddPCR-based vector genome detection, envelope gene assays, or capsid protein identity
Ability to ensure compliance with 21 CFR Part 211, USP <1033>, and ICH Q2(R2)
Experience in developing and justifying specifications for gamma-retroviral vector release and stability
Ability to author Specification Justification Report for Vector
Company
Global Compliance Partners
Global Compliance Partners offers GCP consulting and management services for the biotech and pharmaceutical sectors.
Founded in 2015
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase