Director, Bioassay & External Lab Partnerships

TG Therapeutics, Inc.; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

TG Therapeutics, Inc. is seeking a senior Bioassay Leader to own the technical and operational performance of biologics potency assays across external laboratories and CDMOs/CROs.

The role demands expert knowledge in potency assays for monoclonal antibodies, and cell therapy experience is a strong plus. You will drive accountability, ensure high-quality results, and partner with Quality, Regulatory, MS&T, and Supply Chain to maintain compliance.

Qualifications

• 15+ years of relevant industry experience preferred.
• Demonstrated bioassay expertise with monoclonal antibody potency assays; cell therapy potency is a plus.
• Experience managing external laboratories/CDMOs/CROs and driving accountability.

Responsibilities

• Own external laboratory relationships and performance, including quality, timelines, and results.
• Lead vendor performance improvement and corrective actions to ensure on-time delivery.
• Communicate complex scientific and regulatory issues clearly to vendors and senior leadership.
• Collaborate with Quality, Regulatory, MS&T, Supply Chain to ensure compliant activities.

Skills

Bioassay expertise

Vendor management

Regulatory communication

Cross-functional collaboration

Travel readiness

Education

Advanced degree in Biochemistry/Biological Sciences/Pharmaceutical Sciences/Chemistry

Job description

TG Therapeutics, Inc. is seeking a senior Bioassay Leader to own the technical and operational performance of biologics potency assays across external laboratories and CDMOs/CROs.

The role demands expert knowledge in potency assays for monoclonal antibodies, and cell therapy experience is a strong plus. You will drive accountability, ensure high-quality results, and partner with Quality, Regulatory, MS&T, and Supply Chain to maintain compliance.