Assoc. Dir./Director, Upstream MSAT

Title: Associate Director/Director, Upstream MSAT

Location: Remote

If you are interested in the below position, please send your resume and REFERENCE THE POSITION TITLE within the subject line.

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 has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab‑xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. TG Therapeutics is headquartered in Morrisville, North Carolina. For more information, visit

Role

The Associate Director/Director, Upstream MSAT is responsible for upstream processes for commercial and clinical biopharmaceutical drug substance manufacturing at contract manufacturers. This includes cell culture, cell banks, viral safety testing and seed train/bioreactor/harvest unit operations.

Key Responsibilities

• Scope includes support of Drug Substance (DS) commercial manufacturing, continuous improvement of manufacturing and cost, technology transfer and validation, partnering with supply chain, quality and regulatory groups.
• Prepare and review CMC documentation for upstream sections of regulatory filings including post approval filings with US and EU.
• Provide leadership on strategy and execution of process validation, regulatory, experimental design and areas related to upstream commercial manufacturing and process improvement.
• Analyze and trend process development, process characterization, and manufacturing data.
• Author and review clear and concise technical reports.
• Work with cross functional teams to meet company goals.
• Work as an independent contributor for the company’s major projects.

Professional Experience/Qualifications

• Demonstrated experience in developing cell culture processes for the production of biopharmaceuticals.
• An understanding of the cGMP for biopharmaceuticals, with experience in technology transfer to manufacturing sites, preferred at large scale (≥15 kL).
• Experience with process scale-up, characterization and validation, process control strategy, multivariate analysis and DoE.
• Experienced in authoring CMC sections for commercial regulatory filings.
• Experienced in managing multiple projects and external vendors (CMOs and CROs) concurrently.
• Proven track record of driving projects forward by effectively influencing and collaborating with cross‑functional teams.
• Remote position, available for infrequent travel including international.
• A can‑do attitude to join a dynamic, team‑based, small but growing biotech with a diverse range of opportunities for personal and professional growth.

Education

• PhD/MS in chemical engineering or related areas with 10+ years of industrial experience in the biopharmaceutical industry.

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.

#J-18808-Ljbffr