What are the responsibilities and job description for the Manager, Clinical Supply Chain position at TG Therapeutics, Inc.?
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 approval from the United States Food and Drug Administration (FDA) 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, in adults. TG has also received approval for BRIUMVI by the European Commission (EC) for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features. TG Therapeutics has offices located in New York City, New Jersey, and Raleigh, NC.
Position:
Lead, plan, coordinate, and monitor all Clinical Supply Chain activities. This role will report to the VP, Operations.
Key Responsibilities:
- Lead all clinical supply chain activities, including planning, packaging & labelling, shipping, inventory management, logistics, and temperature management
- Manage clinical supply chain production and transportation partners
- Ensure compliance of logistics activities with standard operating procedures, Good Manufacturing Practices (GMP), Good Distribution Practices, Good Documentation Practices
- Prepare and present clinical supply chain management reports
- Coordinate with Clinical Operations on clinical study startup and execution
- Develop and maintain IRT planning parameters in conjunction with Clinical Operations
- Other responsibilities as needed
- Travel to CMOs / Suppliers 10-20%
Qualifications:
- Knowledge and direct experience managing clinical supply chain activities
- Experience working in a GXP regulatory environment
- Proficient operation of spreadsheets, databases, and other Office programs
- Excellent communication skills and ability to work independently in a team environment
- 3-10 years’ experience in logistics, supply chain, pharmaceuticals or related
- 2-3 years of direct clinical supply chain experience required
- Biologics and/or Cell Therapy experience considered a plus
Education:
- BS in Supply Chain, Operations or equivalent
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.
