External Operations, Senior Associate

Role Summary

The External Operations Senior Associate 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.

Responsibilities

• 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.
• 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.
• 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.

Qualifications

• 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.

Skills

• 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, TrackWise, NetSuite, SAP, etc.).
• Ability to work effectively in a cross-functional team environment.
• Strong analytical and problem-solving skills.
• The ability to work remotely and travel domestically and internationally up to 50%.

Education

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

Additional Requirements

• Ability to travel domestically and internationally up to 50%.