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Title: Associate Director, DP MSAT, Secondary Packaging

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, biotechnology 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 Associate Director, Drug Product MSAT will provide technical and operational oversight of secondary assembly, labeling, and packaging activities for biopharmaceutical drug product in vial and autoinjector presentations. Product(s) include the full lifecycle of clinical and commercial operations at contract development and manufacturing organizations (CDMOs). This role is critical in ensuring reliable supply, compliance with cGMP standards, and successful technology transfer in a fully outsourced, virtual company model. The position requires strong on-floor technical expertise, direct experience managing CDMO partners, and ability to collaborate across internal and external teams in a very dynamic environment. Domestic and international travel to partner sites will be required.

 

Key Responsibilities

• Provide technical oversight and support for labeling & packaging of vials and assembly of syringes into an autoinjector (combination product) followed also by label/pack
• Lead serialization activities, with primary focus on compliance with DSCSA requirements for product distributed in the US
• Own artwork change management for introduction of new and revision of existing labels, inserts, and cartons, including coordination with Supply Chain, Commercial Operations, Regulatory, and CDMOs for its implementation
• Assist in operations troubleshooting, deviation resolution, and complaint management, working closely with Quality Assurance and other key stakeholders and ensuring timely corrective/preventive actions
• Partner with CDMOs to monitor process performance, establish KPIs, and drive continuous improvement. Provide routine reports of process performance to internal stakeholders
• Collaborate with Supply Chain, Quality, Regulatory, and Program Management to align manufacturing activities with company goals
• Contribute to ongoing relationship management, ensuring capacity, redundancy, and compliance across CDMO partners
• Execute technology transfer, process validation, and regulatory filing activities related to new CDMO onboarding
• Author and review CMC documentation for regulatory submissions (INDs, IMPDs, BLAs, MAAs) and assist with responses to Health Authority queries. This specifically includes being a technical expert on combination products
• Participate in cross-functional program reviews and operational planning to support flawless execution of manufacturing deliverables

 

Professional Experience/Qualifications

• 10-15+ years of direct industry experience
• Demonstrated on-floor experience in secondary packaging operations for vial and combination product dosage forms, to include foundational understanding of equipment involved (i.e., assembly, labeling, cartoning, encoding, & vision systems)
• Back-end and floor-level knowledge of serialization systems (e.g., TraceLink)
• Understanding of basic Quality System requirements and experience writing/leading Deviation investigations, implementing CAPAs, and managing/assessing Change Controls
• Direct experience managing CDMO relationships, including oversight of manufacturing, quality, and supply deliverables, and reviewing/approving master/executed batch records, specifications, protocols, reports, and/or product-specific procedures
• Proven ability to stick to directed priorities, pivot quickly when necessary, and organize complex projects with potential competing timelines and resources
• Strong understanding of cGMP requirements for combination product device assembly and secondary packaging/labeling
• Experience leading technology transfer and process validation
• Highly skilled in authoring and reviewing regulatory CMC sections for clinical and commercial filings
• Strong organizational, communication, and interpersonal skills to manage external partners and internal stakeholders
• Ability to proactively troubleshoot and develop solutions in a fast-paced, virtual biotech environment

• Willingness to travel domestically and internationally to CDMO sites

 

Education

• Bachelor’s Degree or above in an engineering or science discipline

• Equivalent combination of education and experience will be considered, with higher emphasis on direct 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.