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

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

Legitimate TG Therapeutics job offers will only come from individuals whose email addresses end in @tgtxinc.com. TG Therapeutics only uses LinkedIn and our TG corporate website for job postings. TG Therapeutics does not use Flock or any other social media platforms other than LinkedIn.

Organizational Overview:

TG Therapeutics is a fully-integrated, commercial-stage, biopharmaceutical 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 has received approval from the United States Food and Drug Administration (FDA) for BRIUMVI (ublituximab-xiiy) in the US and European Commission.

Position:

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

This role requires a deep separations 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:

Separations Technical Leadership

• 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.

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.

Qualifications:

• 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.

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.