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Manager, External Operations

Manager, External Operations

Tonix Pharmaceuticals IncNew Bedford, MA, US
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Job Description

Job Description

About Tonix

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® SymTouch® (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, the rare 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 www.Tonixpharma.com 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.

Position Overview

The External Operations Manager will play a critical role in overseeing the manufacturing across Tonix’s product portfolio. This position will be responsible for managing relationships with external partners, driving operational excellence across our commercial product portfolio. This role will oversee development, manufacturing, and managing quality systems related to manufacturing supply and ensuring compliance with quality and regulatory standards. We are looking for a dynamic and experienced employee that has been involved in technology transfer activities, hands-on experience with manufacturing operations, and worked collaboratively with external organizations and cross-functional teams.

Essential Duties

Product Support

  • Manage product life cycle activities across Tonix product portfolio.
  • Author and revise process documentation for GMP products.
  • Lead continuous process verification activities to ensure product consistency and quality.
  • Analyze process data and implement improvements in collaboration with external partners.
  • Perform risk tools and manage mitigations related to process performance, supply continuity, and change management activities.
  • Provide SME support and engage with cross-functional stakeholders as needed.
  • Manage quality systems (CAPAs, change controls, deviations, and investigations).
  • Support validation activities related to process, packaging, and ship qualification activities.
  • Manage project execution in collaboration with CMC Development leads, Supply Chain, Quality, and Regulatory Affairs Contract Manufacturing Oversight :
  • Oversee CMOs to ensure compliance with Tonix manufacturing processes and testing.
  • Maintain routine meetings with external supply partners, manage agendas, and follow up on action items.
  • Conduct visits to CMOs and supply partner sites to ensure adherence to contractual agreements.
  • Develop and implement performance metrics to evaluate CMO performance.
  • Review supplier documentation and contracts to provide SME input.

    • Support Internal Tonix Programs

  • Manage and communicate CMO performance to ensure timely execution of issues and projects related to business objectives.
  • Execute deliverables to support projects such as new supplier requests, material part requests, etc.
  • Support Regulatory and Quality related audits as a technical SME for commercial products.
  • Participate in cross-functional meetings to discuss product quality, product supply, process improvements, and provide project updates.
  • Collaborate with stakeholders to address quality-related issues and drive continuous improvement against business objectives.

    • Necessary Skills and Abilities

  • Strong knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, ICH).
  • Hands-on experience with manufacturing operations and documentation (such as batch records, protocols, etc.) supporting the production of medical devices or medicines.
  • Experience as an owner of quality systems such as change control, deviation, CAPA, and validation activities.
  • Experience using GMP electronic systems (Veeva, Trace link, Netsuite, Trackwise, SAP etc.)
  • Ability to work effectively in a cross-functional team environment.
  • Strong analytical and problem-solving skills.

    • Educational Requirements

  • BS, MS, or Ph.D. in a relevant scientific field (e.g., chemistry, biology, engineering) or equivalent work experience.

    • Experience Requirements

  • Minimum of 8 years of experience, or an equivalent combination of education and experience, in pharmaceutical or biotechnology.

    • Recruitment & Staffing Agencies

    Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes.

    Compensation & Benefits

    Annualized base salary ranges from $90,000 to $150,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit.

    Tonix provides a comprehensive compensation and benefits package which includes :

  • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs
  • Pet Insurance
  • Retirement Savings 401k with company match and annual discretionary stock options
  • Generous Paid Time Off, Sick Time, & Paid Holidays
  • Career Development and Training

    • Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.

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