Director, Analytical Services - Separations & CDMOs

TG Therapeutics, Inc.; United States; Remote; USD 180,000 - 230,000; Full time

Job summary

TG Therapeutics, Inc. is seeking a Director/Senior Director for Analytical Services (Separations & External Laboratories).

This remote role leads the technical and operational performance of affiliated labs used for commercial biologics, including mAbs. You will own vendor relationships, ensure robust assay performance, and collaborate with Quality, Regulatory, and MS&T to support regulatory commitments and product releases.

Qualifications

• 15+ years of relevant industry experience preferred.
• Commercial-stage biologics and mAbs separations expertise.
• Experience managing external labs/CDMOs/CROs and driving accountability.

Responsibilities

• Own the technical and operational performance of assigned separations and external testing laboratories (CDMOs/CROs).
• Ensure robust assay performance through controls, reagents, and system suitability.
• Evaluate vendor performance, troubleshoot issues, and drive corrective actions.
• Monitor assay trends and address OOS/OOT results, invalids, and repeats.
• Manage external laboratory relationships, quality, timelines, and accountability.

Skills

Chromatography

Electrophoresis

Vendor management

Regulatory submissions

Education

Advanced degree in Biochemistry or related field

Job description

TG Therapeutics, Inc. is seeking a Director/Senior Director for Analytical Services (Separations & External Laboratories).

This remote role leads the technical and operational performance of affiliated labs used for commercial biologics, including mAbs. You will own vendor relationships, ensure robust assay performance, and collaborate with Quality, Regulatory, and MS&T to support regulatory commitments and product releases.