Dir./Sr. Director, Analytical Services (Bioassay & External Laboratories)

TG Therapeutics, Inc.; Northern (KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

TG Therapeutics, Inc. is seeking a Director/Senior Director of Analytical Services (Bioassay & External Laboratories) to own bioassay performance and external testing partnerships across CDMOs/CROs for commercial biologics.

The role demands deep expertise in bioassays, strong vendor leadership, and exemplary communication to ensure high-quality, compliant, on-time execution with international travel as needed.

Qualifications

• 15+ years of relevant industry experience preferred.
• Significant commercial-stage biologics experience with bioassays, particularly monoclonal antibody potency assays.
• Experience managing external laboratories/CDMOs/CROs with accountability and improvement.
• Outstanding written and verbal communication skills for technical/regulatory documents.
• Willingness to travel internationally to vendor sites.
• GMP analytical testing knowledge and regulatory expectations.

Responsibilities

• Lead bioassay technical leadership for monoclonal antibodies and related potency assays.
• Oversee performance of external laboratories/CDMOs/CROs with focus on quality and timely delivery.
• Develop and manage vendor relationships with clear milestones, metrics, and accountability.
• Communicate complex scientific and regulatory issues clearly to leadership and cross-functional teams.
• Support regulatory submissions, method transfers, validation activities, and investigations.

Skills

Bioassay expertise

Vendor management

Regulatory/QA knowledge

Communication skills

Independent work

Travel willingness

Education

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

Job description

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

Location: Remote

Organizational Overview

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. For more information, visit www.TGTherapeutics.com.

Role

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

This role requires a deep bioassay expert, exceptional vendor leader, and outstanding communicator who can build strong external partnerships while holding laboratories accountable for high-quality, compliant, and on-time execution. The successful candidate will operate independently with urgency, sound judgment, and ownership of outcomes.

Key Responsibilities

Bioassay Technical Leadership

• Serve as an ASG subject-matter expert for biologics potency assays, particularly for monoclonal antibodies; cell therapy potency experience is a strong plus.
• 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.

Communication, Regulatory & Cross-Functional Leadership

• 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.

Professional Experience/Qualifications

• 15+ years of relevant industry experience preferred. Title is commensurate with years of experience.
• Significant commercial-stage biologics experience with demonstrated expertise in bioassays, particularly monoclonal antibody potency assays required and cell therapy potency experience a strong plus.
• 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.

Education

• 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, age, disability, national origin, ancestry, genetic information, military or veteran status, pregnancy or pregnancy-related condition or any other protected characteristic.