Senior Manager, Engineering

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 Senior Manager of Engineering will play a critical role in overseeing Tonix’s project portfolio and supporting manufacturing-enabling initiatives that advance the company’s product portfolio. This position will be responsible for managing relationships with external partners and driving operational excellence across our product execution. The role will also contribute to long-term strategic planning by identifying opportunities to optimize manufacturing capabilities and improve cross-functional collaboration.

Essential Functions

Project Portfolio Management

• Lead and support engineering projects across internal and external manufacturing strategies.
• Ensure timely execution and alignment with business goals and budget constraints.

Contract Manufacturing Support

• Manage engineering efforts with contract manufacturers for late-phase and commercial programs.
• Ensure deliverables meet quality, compliance, and operational standards.

Engineering Lifecycle & Validation Integration

• Develop and manage engineering lifecycle programs.
• Integrate validation strategies to support product readiness and regulatory compliance.

Cross-Functional Collaboration

• Engage with cross-functional teams including Quality, Regulatory, Supply Chain, and Finance to ensure project alignment and execution.

Quality Systems Management

• Oversee quality system changes impacting late-stage or commercial programs.
• Ensure compliance with internal and external standards.

Vendor & Consultant Management

• Manage third-party consultants and external resources performing engineering and validation deliverables.
• Ensure contractual obligations and performance metrics are met.

Facilities Support

• Support ongoing engineering and facilities activities at the Advanced Development Center.
• Ensure budget adherence and operational continuity.

Project Justification & ROI Analysis

• Conduct project justification assessments, including alignment with charter deliverables, quality and compliance drivers, and return on investment evaluations.

Financial & Procurement Oversight

• Onboard critical partners, manage contracts and purchase orders, and support regular financial reporting and budget tracking.

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.
• The ability to work in a remotely and travel domestically and internationally up to 50%
• Excellent communication, organizational, and leadership skills.
• Proficiency in project management tools and financial reporting systems.

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 $100,000 to $170,000 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.