Remote Director, Bioassay & External Lab Analytics

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

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.