VP, Manufacturing Science and Technology; MS&T

Title:
Vice President of Manufacturing Science and Technology (MS&T)

Location:
Remote

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 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,

The Vice President of MS&T is the discipline leader of a team responsible for management a manufacturing science and technology group  role provides both guidance and active management of these tasks.

Responsibilities encompass oversight and support of drug substance and drug product commercial and clinical manufacturing, technology transfer, process development, process validation, manufacturing supply and regulatory filing activities. It includes continuous improvement of manufacturing and cost of goods.

The candidate leads the team responsible for achieving excellence in identifying and creating strategic partnerships with a network of global CDMO’s. TG is a virtual company so all work is outsourced; this individual will work with both the internal team and outside partner contractors. A strong background in manufacturing support of drug substance (especially cell culture) and drug product are essential as is experience supporting commercial manufacturing and regulatory filings.

This position is remote and will require international travel as needed.

• Responsible for the generation of drug substance/product, including process development, manufacturing technical support, validation, process characterization, scale up and technical transfer
• Manage MS&T team including all aspects of Drug Substance and Drug Product including process development, validation, process characterization, scale up, and tech transfer.
• Manage partnerships with multiple CDMO’s and develop strategies to ensure redundancies and options for drug production
• Prepare and review CMC documentation for biologic INDs and BLAs and support regulatory agencies (FDA, EMEA and others) interactions
• Work closely with partners in Analytical Sciences, Supply Chain, Operations, Quality, Program Management, and Regulatory and across appropriate stakeholders for program review and decision making
• Responsible with operations leadership team to recommend, organize and action a standing list of "flawless execution" and "good to great" initiatives

• Minimum of 15 years’ experience in the biopharmaceutical industry as a drug production professional with successful BLA submissions and extensive experience with commercialization and support of commercial manufacturing.
• Direct experience in development, manufacturing and testing of monoclonal antibodies and/or other protein biologics
• Experience in all phases of CMC regulatory submissions and interactions regarding CMC issues, ideally including post approval experience and international experience and negotiation and experience with regulatory authorities on CMC issues related to biologic drug substances
• Experience leading a…