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Title: Senior Vice President, CMC

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 Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by several foreign nations for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. For more information, visit www.TGTherapeutics.com.

Role

The Senior Vice President (SVP), CMC, is a key member of the Technical Operations Leadership Team and is responsible for providing strategic, scientific, and operational leadership for the Company’s Manufacturing Science & Technology (MSAT) and Analytical Sciences organizations. This executive will oversee all commercial and late-stage development MSAT activities, analytical sciences, product lifecycle management, process validation support, technology transfer, regulatory support, and manufacturing troubleshooting to ensure a reliable, compliant, and scalable supply of commercial products.

The SVP will lead a highly technical organization responsible for supporting commercial product supply, including manufacturing, lifecycle management, analytical development, process improvements, investigations, comparability assessments, technology transfers, regulatory submissions, and future product launches. This leader will work closely with Project Management, Quality, Regulatory Affairs, Supply Chain, and external manufacturing and testing partners to ensure successful execution of corporate objectives.

As a highly visible executive, the SVP is expected to be an engaged, hands-on leader who combines strategic vision with the willingness to personally engage in complex scientific, technical, and operational challenges. This role is critical to supporting commercial operations while preparing the organization for future growth and expansion.

 

Key Responsibilities

Executive Leadership

• Develop and execute the long-term strategy for the MSAT and Analytical Sciences organizations in alignment with the Company’s corporate objectives.
• Build, develop, and lead high-performing technical teams while fostering a culture of scientific excellence, accountability, collaboration, innovation, and continuous improvement.
• Serve as a trusted advisor to executive leadership on manufacturing, analytical, technical, and CMC strategy.
• Drive organizational scalability to support commercial growth and future product launches.

Manufacturing Science & Technology

• Provide leadership for commercial MSAT supporting upstream, downstream, drug substance, drug product, fill-finish manufacturing, and device.
• Lead process performance monitoring, process optimization, continued process verification (CPV), and lifecycle management activities.
• Oversee technology transfers between development, internal operations, and global contract manufacturing organizations (CMOs).
• Direct manufacturing investigations, root cause analyses, technical risk assessments, CAPAs, and implementation of sustainable process improvements.
• Support process validation, process characterization, PPQ, and manufacturing readiness activities.
• Partner with Manufacturing and Quality to improve process robustness, manufacturing reliability, yield, and product quality.

Analytical Sciences Group (ASG)

• Provide executive leadership for analytical development and commercial analytical support.
• Oversee assay development, qualification, validation, transfer, lifecycle management, and continuous improvement of analytical methods.
• Ensure commercial assay performance meets regulatory requirements and business needs.
• Direct analytical investigations related to OOS, OOT, deviations, complaints, stability trends, and product lifecycle management.
• Oversee analytical support for manufacturing, stability programs, comparability assessments, specifications, and reference standards.
• Ensure analytical readiness for new product introductions and post-approval changes.

Commercial Manufacturing Support

• Provide technical oversight supporting commercial manufacturing operations across internal facilities and contract manufacturing organizations.
• Ensure rapid resolution of manufacturing and analytical issues that could impact product supply.
• Lead cross-functional technical review teams during significant manufacturing events.
• Support manufacturing campaigns through direct technical engagement when required.

Regulatory and CMC Support

• Provide executive leadership for CMC sections of regulatory submissions, including BLAs, INDs, supplements, annual reports, and global regulatory filings.
• Review and approve technical documentation supporting regulatory submissions.
• Serve as the technical subject matter expert during regulatory agency interactions and inspections.
• Support health authority responses, inspection readiness, and commitments.

External Manufacturing and Vendor Management

• Provide technical oversight of multiple global CMOs, contract testing laboratories, and strategic external partners.
• Establish strong technical governance with external manufacturing organizations.
• Evaluate vendor performance and implement continuous improvement initiatives.
• Support selection, qualification, and oversight of new manufacturing and analytical partners.

Cross-Functional Leadership

• Partner closely with:
  • Manufacturing Operations
  • Quality Assurance and Quality Control
  • Regulatory Affairs
  • Supply Chain
  • Technical Operations Program Management
  • Clinical Supply
  • Finance
• Drive strategic decision-making across Technical Operations.
• Support due diligence activities, licensing opportunities, and business development initiatives as needed.

Continuous Improvement

• Champion operational excellence using science- and risk-based decision making.
• Drive innovation in manufacturing technologies, analytical methodologies, automation, and digital data management.
• Develop organizational capabilities to support future commercial expansion.

Professional Experience/Qualifications

Experience

• Minimum of 20 years of progressive biotechnology or pharmaceutical industry experience, including significant executive leadership responsibilities.
• Demonstrated success within both emerging biotechnology companies and large global biopharmaceutical organizations, with the ability to apply the agility of smaller companies alongside the operational rigor and scalability of larger enterprises.
• Extensive commercial-stage monoclonal antibody (mAb) manufacturing experience with deep knowledge of biologics process development, technology transfer, validation, and lifecycle management.
• Significant experience supporting commercial manufacturing operations, including drug substance, drug product, and fill-finish manufacturing.
• Proven leadership of both Manufacturing Science & Technology and Analytical Sciences organizations.
• Extensive experience supporting analytical method development, validation, lifecycle management, and commercial assay support.
• Demonstrated experience leading multiple successful regulatory submissions, including BLAs, post-approval supplements, and global CMC filings.
• Strong experience authoring, reviewing, and directing CMC regulatory documentation and interacting directly with global regulatory agencies.
• Extensive experience managing multiple contract manufacturing organizations (CMOs), contract development and manufacturing organizations (CDMOs), contract testing laboratories, and other strategic outsourcing partners.
• Experience leading complex manufacturing investigations, process improvements, and technical troubleshooting across commercial operations.
• Proven experience supporting regulatory inspections, responses, and remediation activities.
• Experience leading global, cross-functional technical organizations through periods of organizational growth and commercialization.

Leadership Competencies

• Demonstrated ability to lead highly technical, multidisciplinary organizations in a fast-paced commercial biotechnology environment.
• Hands-on leadership style with a willingness to engage directly in technical problem-solving, critical investigations, strategic planning, and operational execution.
• Exceptional strategic thinking coupled with strong execution and operational discipline.
• Outstanding communication and presentation skills, with the ability to translate complex technical information for executive leadership, Board members, and regulatory agencies.
• Strong people leadership skills with a proven ability to attract, develop, mentor, and retain top scientific talent.
• Demonstrated ability to influence across all organizational levels without relying solely on formal authority.
• High degree of business acumen with the ability to balance scientific rigor, regulatory compliance, operational excellence, and financial considerations.
• Excellent organizational, prioritization, and decision-making skills in a rapidly changing environment.

Technical Competencies

• Deep knowledge of biologics manufacturing processes, including upstream, downstream, formulation, drug product, device, and aseptic manufacturing.
• Comprehensive understanding of analytical characterization, potency assays, stability programs, comparability studies, and analytical lifecycle management.
• Thorough knowledge of current GMP regulations, ICH guidance, FDA, EMA, and other global regulatory requirements.
• Strong understanding of process validation, continued process verification, statistical analysis, quality systems, and risk management methodologies.
• Experience implementing modern manufacturing technologies, data analytics, and continuous improvement methodologies to enhance commercial operations.

Personal Attributes

• Collaborative, transparent, and accountable leadership style.
• High integrity with a strong commitment to patient safety, product quality, and compliance.
• Resilient, adaptable, and comfortable operating in a dynamic, growth-oriented environment.
• Demonstrated ability to make timely, data-driven decisions while maintaining a long-term strategic perspective.
• Passion for building high-performing teams and fostering a culture of continuous learning and innovation.

Education

• Ph.D. in Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Biology, Chemistry, or a related scientific discipline strongly preferred.
• Advanced scientific degree (Ph.D.) preferred; Master’s degree with extensive industry experience may be considered.

Applicants must be currently authorized to work in the United States on a full-time basis. The company does not sponsor employment visas for this position.

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.