Senior Scientist, AD/QC-GMP Bioassay & ddPCR (AAV)

Location: On‑site (embedded within partner laboratory)
Function: Analytical Development / Quality Control (GMP)

Position Overview

Our client is seeking a highly skilled Senior Scientist with deep hands‑on expertise in GMP bioassays, cell‑based potency methods, and digital droplet PCR (ddPCR) to support analytical development and quality control activities for AAV-based gene therapy programs.

This role is best suited for a seasoned laboratory professional who thrives at the bench, maintains exceptional documentation standards, and can operate seamlessly within another company's laboratory, workflow, and reporting structure.

Key Responsibilities

• Execute GMP-compliant cell-based potency assays, including assay qualification and validation activities.
• Perform ddPCR-based quantification for AAV programs; lead troubleshooting, optimization, and method robustness activities.
• Operate with a strict audit-ready mindset, ensuring high-quality documentation in alignment with GMP and data integrity expectations.
• Support and execute analytical validation protocols, not limited to routine batch or release testing.
• Contribute to AAV analytical development, including potency, vector characterization, and purity methods where applicable.
• Integrate seamlessly into an external partner's lab environment, following their internal systems, reporting structures, and communication pathways.
• Support batched, plate-based assays and coordinated testing workflows across teams.
• Collaborate cross-functionally with internal teams, CDMOs, and external partners to support ongoing development and QC activities.

Must-Have Qualifications (Non-Negotiable)

• Minimum 5+ years of GMP laboratory experience.
• Strong hands-on experience performing GMP cell-based potency assays.
• Direct experience with ddPCR (qPCR-only backgrounds will not be considered).
• Proven track record executing validation protocols (e.g., accuracy, precision, linearity, specificity, robustness).
• Excellent documentation discipline with consistent audit-readiness.
• Ability and willingness to embed within another company's lab and operate under their reporting structure (high adaptability and professionalism).

Strongly Preferred Qualifications

• Experience with AAV vectors or gene therapy analytical methods.
• Working knowledge of CGE or other protein purity / capsid purity techniques.
• Prior experience working in cross-company environments, CDMOs, or partner-embedded models.
• Experience supporting batched, high-throughput plate-based assays.

Profiles That Will Not Be Considered

Please do not apply if you are:

• A junior QC analyst with fewer than 3 years of GMP experience.
• Limited to non-GMP academic or development-only work.
• Experienced only in qPCR without direct ddPCR execution.
• Primarily a strategy-focused scientist who does not execute assays hands-on.
• Uncomfortable reporting directly into another company's team structure.