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

Location: Remote

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

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, visit www.tgtherapeutics.com.

Role

The Vice President of MS&T is the discipline leader of a team responsible for management a manufacturing science and technology group at TG.  The 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.

Key Responsibilities

• 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

 

Professional Experience/Qualifications

• 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 process development, MS&T, tech ops or manufacturing function for a biopharmaceutical company.
• Excellent interpersonal, organizational, negotiation and communication skills; a team member that can work collaboratively with colleagues across all functions
• Excellent analytical, presentation, and writing skills are essential
• Experience managing biologics process development and clinical commercial activities through CDMO’s
• Knowledge and expertise in principles and practices of cGMP for biologics manufacture of drug substances and drug products, with experience with CAR-T therapies, and combination products a plus
• Excellent oral and written communication skills for effectively interfacing with internal and external organizations
• Effective leadership and managerial skills as well as the ability to manage multiple priorities with aggressive timelines and changing priorities
• Ability to troubleshoot, identify root causes and systematically resolve problems
• A can-do attitude leading a dynamic team in a commercial biopharmaceutical company
• Ability to travel domestically and internationally as needed.

 

Education

• Advanced degree in relevant scientific discipline, preferably a PhD in chemical engineering, biochemistry or related area with 15+ years of relevant experience.

 

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.