Dir​/Sr. Dir., Analytical Services; Separations & External Laboratories

Title:
Director/Senior Director, Analytical Services (Separations & External Laboratories)

Location:
Remote

TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by several foreign nations for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features.

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Own the technical and operational performance of assigned separations and external testing laboratories (CDMOs/CROs) supporting commercial biologics.

• Serve as an ASG subject-matter expert for chromatographic and electrophoretic assays, particularly for monoclonal antibodies.
• Ensure robust and reproducible assay performance through strong understanding of assay variability, controls, critical reagents, system suitability, and laboratory execution.
• Critically evaluate vendor performance, troubleshoot complex assay issues, identify root causes, and drive effective corrective actions.
• Monitor assay performance and proactively address adverse trends, OOS/OOT results, invalids, repeats, and system suitability failures.
• Own assigned external laboratory relationships and performance, including quality, timelines, responsiveness, and results.
• Build strong, collaborative vendor relationships while establishing clear expectations, milestones, metrics, and accountability.
• Proactively identify risks, elevate when necessary, and drive vendors to deliver right-first-time and on-time execution for release, stability, investigations, method transfers, and regulatory commitments.
• Lead vendor performance improvement using objective data and ensure corrective actions result in sustained improvement.
• Travel to vendor laboratories as needed to troubleshoot, understand execution firsthand, align teams, and accelerate resolution.

• Communicate complex scientific, quality, and regulatory issues clearly, concisely, and persuasively to vendors, technical teams, and senior leadership.
• Author and critically review high-quality analytical and regulatory content supporting BLAs, supplements, validation, comparability/bridging, investigations, and inspections.
• Translate complex issues into clear risks, recommendations, decisions, owners, and actions.
• Partner effectively with Quality, Regulatory, MS&T, Supply Chain, and other functions to ensure analytical activities are scientifically sound, compliant, inspection-ready, and aligned with regulatory commitments.

• 15+ years of relevant industry experience preferred. Title is commensurate with years of experience.
• Significant commercial-stage biologics experience with demonstrated expertise in separations relevant to mAbs
  .
• Demonstrated success managing external laboratories/CDMOs/CROs, including building strong relationships while driving accountability, performance improvement, and on-time delivery
  .
• Outstanding written and verbal communication skills
  , including demonstrated ability to produce concise, high-quality technical/regulatory documents and effectively communicate complex issues to senior leadership.
• Experience supporting regulatory submissions and strong knowledge of GMP analytical testing, investigations, method transfer/validation, and regulatory expectations.
• Highly independent, proactive, and accountable, with the judgment and urgency to drive complex issues through resolution.
• Willingness to travel internationally to vendor sites as needed.

• Advanced degree in Biochemistry, Biological Sciences, Pharmaceutical Sciences, Chemistry, or related discipline

Applicants must be currently authorized to work in the United States on a full-time basis. The company does not sponsor employment visas for this position.

TG Therapeutics is an equal employment opportunity employer, and does not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity or expression,…