Senior Specialist, QC North Dartmouth, MA

Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement.

Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® Sym Touch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults.

Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases.

Finally, therare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA.

Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.

Please visit  for specifics on the pipeline.

* All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

The Senior Specialist of Quality Control will oversee contract organization method development in support of product release, process development and stability. This position would be responsible for implementation and development of quality control expectations on investigational products and commercial operations including analytical development and assay troubleshooting. The Sr. Specialist will support all aspects of this process including analytical development, product release, stability trending, ICH guidance adherence and support all aspects as required by the internal and contract quality systems.

• Oversee the implementation of general laboratory operational systems and testing capabilities, related method development, transfer and qualification activities, investigations, data trending and assay/instrument troubleshooting
• Support the development and implementation of new analytical methods as required to meet quality attributes
• Oversee the in-process and release product testing in support of manufactured drug substance and drug product to ensure the product meets quality attributes performed at contract organizations
• Collaborate with the other Quality and functional area to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate
• Provide support for the appropriate strategic planning for continuous improvement and reporting/escalation of issues and/or risk mitigation activities to ensure a culture of quality and compliance
• Oversee product stability studies aligned with ICH guidelines to support shelf life and product retest assessment
• Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s)
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork

• Strong understanding of regulatory testing (USP, EP, ICH) regulations
• Strong understanding method validation requirements to meet regulatory expectations
• Strong understanding of analytical techniques used to assess quality attributes of biological, viral and or small molecule drug substances and products
• Ability to perform statistical trending of…