Sr. Dir./Executive Director, Drug Product, MS&T

Title: Senior/Executive Director, Drug Product, MS&T

Location: Remote

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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

Role

The Sr/Executive Director, Drug Product MS&T is responsible for drug product processes for commercial and clinical biopharmaceutical drug product manufacturing at contract manufacturers. This includes experience with combination products/autoinjector devices, with biologics. Responsibilities encompass process development, trouble shooting, analytics, technology transfer, process validation, and regulatory filing activities.

TG is a virtual company, so all work is outsourced. This individual will work with both the internal team and outside partner contractors, so strong management and interpersonal skills are critical. This position is remote and will require both domestic and international travel.

Key Responsibilities

• Responsible for the support, troubleshooting and process performance of drug product manufacturing, including extensive experience with combination products/devices and autoinjectors, with biologics.
• Provide leadership on strategy and execution of process validation, regulatory objectives, experimental design and areas related to drug product commercial manufacturing and process improvement.
• Provide leadership on the selection and management of vendors of DP fill, assembly, and secondary labeling/packaging sites.
• Analyze and trend process development, process characterization, and manufacturing data.
• Write, edit, review appropriate regulatory sections for INDs, IMPDs, BLAs, MAAs, and post approval filings (PAS and Variations). Rapidly respond to Health Authority requests for information during review periods or audits
• Work with cross functional teams to meet company goals, especially TG Supply Chain, Upstream and Quality teams.
• Manage partnerships with multiple CMOs and develop strategies to ensure redundancies and options for commercial drug production
• Work closely with partners in Supply Chain, Operations, Quality, Program Management, Regulatory, and across appropriate stakeholders for program review and decision making
• Responsible, with MS&T leadership, to recommend, organize and action a standing list of “flawless execution” and “good to great” initiatives, which will develop into next year’s key goals for the operations team

Professional Experience/Qualifications

• Demonstrated experience in the generation and release of drug product combination devices, such as an autoinjector, in the biologics space
• On-the-floor experience operating or managing a cGMP drug product aseptic filling, assembly, and/or secondary packaging area
• Ability to troubleshoot, proactively plan and develop the path forward
• An understanding of the cGMP for biopharmaceuticals, with extensive experience in technology transfer to manufacturing sites
• Experience with process scale-up, characterization and validation, process control strategy, multivariate analysis and DoE.
• Experienced in authoring CMC sections for commercial regulatory filings.
• 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

• PhD or equivalent experience in chemical engineering, pharmaceutical science 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.