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Title: Sr. Director/Exec. Dir., Upstream, 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 Sr Director, Upstream MS&T is responsible for upstream processes for commercial and clinical biopharmaceutical drug substance manufacturing at contract manufacturers.  This encompasses cell culture including seed train/bioreactor/harvest unit operations as well as cell banking and viral safety testing.   Responsibilities include manufacturing support, trouble shooting, data analysis, technology transfer, process validation, and regulatory filing activities as well as some process development.  TG is a virtual company so all work is outsourced; this individual will work with both the internal team and outside partner contractors. This position is remote and will require international travel as needed.

Key Responsibilities

• Responsible for the support, troubleshooting, and process performance of upstream manufacturing including primarily commercial manufacturing of biologics.  Related areas include cell culture process understanding, process characterization and troubleshooting, scale up, technical transfer and process validation.

• Provide leadership on strategy and execution of upstream commercial manufacturing performance (including but not limited to scrap reduction, raw material management and component usage), process validation, regulatory, and experimental design.
• 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.

• Manage partnerships with multiple CDMO’s and develop strategies to ensure redundancies and options for drug production.
• Work closely with partners in 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, which will develop into continuous improvement.

Professional Experience/Qualifications

• Proven track record of successful upstream commercial manufacturing including process monitoring and troubleshooting, cost of goods reduction, and business impact of process changes and improvements.
• Demonstrated experience in developing cell culture processes for the production of biopharmaceuticals.
• Experience with process scale-up, process characterization and validation, process control strategy, and multivariate analysis.
• An understanding of the cGMP for biopharmaceuticals, with experience in technology transfer to manufacturing sites, preferred at large scale (≥15,000L).
• Experienced in authoring CMC sections for commercial regulatory filings and post-approval communications.
• Ability to trouble shoot and proactively plan and develop the path forward
• Supervisory experience leading a technical team.
• Significant organizational and communication skills are essential to work with 3^rd party vendor partner companies.
• 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.
• Candidate must be available to travel to partner sites, including international.

Education

• A PhD (or equivalent experience 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.