Director of Separations & External Analytical Partnerships

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

Job summary

TG Therapeutics, Inc. is seeking an experienced professional to own the technical and operational performance of assigned separations and external testing laboratories (CDMOs/CROs) supporting commercial biologics.

The role requires an expert in separations, strong vendor leadership, and excellent communication to ensure high-quality, compliant, and on-time execution. The successful candidate will travel internationally as needed, build partnerships with vendors, and drive continuous improvement

Qualifications

• 15+ years of relevant industry experience preferred.
• Significant commercial-stage biologics experience with separations relevant to mAbs.
• Demonstrated success managing external laboratories/CDMOs/CROs, including building relationships while driving accountability and on-time delivery.
• Outstanding written and verbal communication skills.
• Experience supporting regulatory submissions and knowledge of GMP analytical testing, investigations, and method transfer/validation.
• Willingness to travel internationally to vendor sites.

Responsibilities

• Own the technical leadership of separations and external labs supporting commercial biologics.
• Evaluate vendor performance, troubleshoot assay issues, identify root causes, and drive corrective actions.
• Monitor assay performance and address OOS/OOT results, invalids, repeats, and system suitability failures.
• Manage external laboratory relationships with quality, timelines, and responsiveness.
• Communicate complex scientific and regulatory issues clearly to vendors, teams, and leadership.
• Collaborate with Quality, Regulatory, MS&T, and Supply Chain to ensure analytical activities are compliant and inspection-ready.

Skills

Communication

Vendor leadership

Regulatory communication

Education

Advanced degree in Biochemistry/related

Job description

TG Therapeutics, Inc. is seeking an experienced professional to own the technical and operational performance of assigned separations and external testing laboratories (CDMOs/CROs) supporting commercial biologics.

The role requires an expert in separations, strong vendor leadership, and excellent communication to ensure high-quality, compliant, and on-time execution. The successful candidate will travel internationally as needed, build partnerships with vendors, and drive continuous improvement