About Tonix

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview

Tonix is looking for a full-time Accounts Payable Associate who is responsible for overseeing and maintaining the disbursements cycle and ensuring that key AP-related initiatives are completed in a timely and accurate manner. The candidate should have experience operating in an accounts payable capacity as well as a working knowledge of accounting.

This position will report directly to the Senior Manager of Accounting and will be based in the Tonix facility in Frederick, MD.

Essential Duties

• Coordinate, validate, and process all electronic and paper invoices for US and international entities using the MS Great Plains accounting system as well as ensure accurate approval and coding of all invoices
• Build and maintain effective relationships with vendors and ensure timely, accurate payments and be the point of contact for any vendor inquiries
• Track and ensure accurate currency conversions for international vendors and entities
• Ensure employee expense reports are received by set departmental deadlines and audit expenses for accuracy and timeliness
• Responsible for IRS 1099 compliance and assist with year end filings
• Ensure all policies, processes and controls are compliant with the Sarbanes Oxley Act
• Complete purchase orders and review for accuracy
• Liaise with internal departments as required to resolve issues
• Perform administrative and clerical tasks, such as: data entry, sending bill reminders, filing paperwork, and entering invoices and payments into our accounting system
• Set up new vendors and file all the completed W-9 Forms
• Perform other duties as required to support the Accounting Department
• Protects organization’s value by keeping information confidential
• Save all invoices properly with approvals
• Assist team with gathering support for all audits, including pulling documentation
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

• Bachelor’s degree in Finance, Accounting or related field preferred
• Three years financial work experience including three years direct responsibility for A/P functions in a corporate environment
• Experience with Microsoft Dynamics Great Plains accounting system strongly preferred
• Working knowledge of accrual accounting, general ledgers, and journal entries preferred
• Strong computer skills and proficiency in all Microsoft Office applications
• Strong organizational aptitude and meticulous attention to detail and accuracy
• Familiarity with FX transactions
• Ability to work in a small-team environment
• Working knowledge of contracts, purchase orders, and change orders
• Dedicated team player who is able to withstand the high demands of a fast-paced environment
• Excellent written, organizational, and verbal communication skills are essential
• Strong planning and organizational skills
• Comfortable working independently with minimal supervision
• Highly organized, results driven, problem solver, collaborator
• Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to human.resources@tonixpharma.com and include Accounts Payable Associate in the subject of the email. 

About Tonix:

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview:

Based on the expansion of it its R&D platform, Tonix is looking for an Analytical Development Subject Matter Expert (SME) to supplement its internal and external team.

The Analytical Development SME will be responsible for developing methods designed at characterizing and/or measuring the critical quality attributes (CQAs) of viral vaccine products. The individual in this position will be responsible for independently designing and executing laboratory experiments, compiling relevant findings into reports, and presenting results to internal and external stakeholders across the portfolio of Tonix viral vaccine products.

The individual in this position will be highly motivated with experience and interest in working with CDMOs and on-site role, in a dynamic, cross-functional, entrepreneurial environment with broad responsibilities and opportunities.

Tonix is currently constructing its own Advanced Development Centre (ADC) facility which will be ready for commissioning in North Dartmouth, MA in Q1, 2022. The position will be based in this ADC facility once open and operational. Remote work arrangements will be in place until such time. The earlier the individual can start will allow them take part in the set-up of the laboratory along with the design team.   

Essential Duties

• Lead projects associated with establishing robust and compliant analytical methods at Tonix
• Own and maintain the knowledge and history of Tonix method development and qualification throughout the method and product lifecycle
• Prepare and review technical documents such as test method SOPs, product specifications, qualification and test protocols, technical reports, sampling plans, risk assessments, and/or relevant sections for regulatory submission files
• Provide first line technical support to QC and development testing laboratories in compliance with relevant instructions and quality requirements
• Design new analytical methods or refine existing methods
• Lead method transfers from Internal (Discovery) or external (CDMO) laboratories, method optimization and qualification
• Develop and support HPLC/UPLC methods (Agilent and Thermo HPLCs/UPLCs; SEC, IEX, and RP using UV, FLR, CAD, and MALS) to measure the CQAs of viral vaccine products
• Develop and support LC-MS/MS methods to characterize the nucleic acid, protein, and/or lipid components of viral vaccine products
• Lead the transfer of developed methods and acquired knowledge to the Quality Control team
• Author and reviewing analytical test methods, data summaries, protocols, and technical reports
• Engaging with internal and external stakeholders and customers to set strategic goals, generate workplans, and discuss findings
• Use scientifically sound rational and statistical tools for data analysis, contribute to enhancing process understanding and identifying key sources of variability and root causes of product and process failures
• Support change review and implementation, quality investigations, CAPAs in cross-functional teams
• Participate in the definition and selection of analytical instruments by providing input to User Requirement Specifications (URS) and creating associated procedures
• Support instrument qualification activities
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

• Advanced degree in biochemistry, analytical chemistry, or related discipline with five+ years of industry experience or Bachelor’s in biochemistry, analytical chemistry, or related discipline with seven years of industry experience or equivalent combination of education and experience
• Experience with biochemical, physicochemical and/or biologic activity methods
• Project management experience
• Experience in experimental design and statistical analysis methodology
• Experience with projects in clinical development e.g., Phase 1 through Phase 3
• Experience in the area of viral vaccines, viral vector or monoclonal antibodies strongly preferred
• Experience with cGMP manufacturing and regulatory submissions is a plus
• Ability to identify and resolve critical issues
• Good interpersonal and stakeholder management skills to collaborate with and direct the work of others on assigned projects, including both internal teams and external collaborators.
• Demonstrated ability to develop methods to characterize or measure the CQAs of in-process and release samples
• Experience developing methods for viral vaccines or gene therapy products strongly preferred
• Experience with the following techniques: ELISA, gel electrophoresis, DLS, DSC, AUC, and capillary electrophoresis (CE-SDS, cLIF, cIEF)
• Dedicated team player who is able to withstand the high demands of a fast-paced environment
• Excellent written, organizational, and verbal communication skills are essential
• Strong planning and organizational skills
• Comfortable working independently with minimal supervision
• Highly organized, results driven, problem solver, collaborator
• Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to human.resources@tonixpharma.com and include Analytical Development Scientist in the subject of the email. 

The Clinical Trial Associate (CTA) is involved in the conduct of the study and interfaces closely with the Program/Project Managers and the Clinical Team.

The CTA also supports the Clinical Team by creating and distributing study team materials, tools and documents and ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support. The CTA will work as a crucial team member with the Clinical Team in completing all required tasks to meet departmental and project goals.

Responsibilities will vary based on whether the study is insourced or outsourced, phase of the study lifecycle (start up, maintenance, close out).

Job Description (Functions and Responsibilities):

• Creating and/or reviewing study plans, specification documents, materials and tools.
• Oversight of documents (e.g. FDA 1572, CVs, FDF, etc.) required for Tonix Regulatory from site initiation to site close out.
• QC oversight of CRO, TMF, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs and timelines.
• Be familiar with the roles of the Clinical Research Associates (CRA) including site visits, if appropriate.
• Assist in organizing, scheduling, and attending Tonix site visits, if required.
• Develop and maintain good working relationships with investigators and sites staff.
• Function as liaison between investigative sites and the Tonix Medical Monitors, and ensure follow up/closure of action items.
• Ensure trial sites carry out recruitment and screening procedures according to the study protocol and in accordance with ICH/GCP regulations and study-specific guidelines.
• Identify and monitor the progress and obstacles of assigned study(ies) by implementing follow up strategies on any potential action items identified on site visits or in communication with sites.
• Assist in the set-up, organization, and maintenance of project Share Point (folders, documents)
• Support submission of documents required for TMF from Sponsor study team.
• Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors.
• Generate, finalize and distribute study team agendas and meeting minutes, where required. Review CRO meeting minutes.
• Assist in the production of slides, as needed for projects.
• Attend (and contribute where required) to internal Tonix meetings and CRO/vendor project meetings.
• Ability to communicate clearly both verbally and written to sites, vendors, CROs, internal study team, etc.
• Be familiar with ICH GCP, appropriate regulations, relevant Tonix SOP’s and internal tracking systems.
• Tracking and reporting on progress of study including site activation, recruitment activities, patient enrollment, and CRO monitoring visits (where assigned).
• Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determining appropriate action in conjunction with Tonix study team.
• Other duties as assigned

Job Requirements

• Bachelor’s degree in science and at least 5 years of experience in randomized clinical trials in central nervous system indications
• Prior experience in role of CTA for randomized clinical trials
• Highly organized with excellent communication skills
• Versatile with MS Office applications (Word, Excel, PowerPoint) and SharePoint cloud services
• Works well with a multiple disciplinary internal clinical team as well as in interactions with CROs/vendors

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to human.resources@tonixpharma.com and include “Clinical Trial Associate” in the subject line of the email. 

This position would be based out of a Tonix office location (Chatham, NJ; Sand Diego, CA; Dartmouth, MA; Frederick, MD).

About Tonix:

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview:

The QC Associate Director/Director will be responsible for the leadership of the Quality Control department. In addition to routine testing, this role will have responsibility for the management of related method transfer and qualification activities and will assist in the development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements. Also, the individual will be overseeing the buildout of the QC laboratories of a site specific GMP manufacturing facility in North Dartmouth, MA opening in 2022. The individual in this position will have the unique opportunity to hire, train and oversee performance management, mentoring and career development.

This position will work with the other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate.  Also, this role will also provide the appropriate QC strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities and to ensure a culture of quality and compliance.

This position reports into the Head of Quality and is a member of the Quality management team at the facility.  The role will be based out of the new facility in North Dartmouth, MA once open and operational. Remote work arrangements will be in place until such time. 

Essential Duties:

• Oversee day-to-day operations of the Quality Control department including bioassay, biochemistry, chemistry, microbiology, and stability functions
• Manage laboratory personnel and oversee their selection, performance management, mentoring, and career development
• Implement general laboratory operational systems to support GMP activities
• Assist in development of appropriate Standard Operating Procedures and laboratory data collection & documentation systems (paper and electronic) to ensure cGMP compliance
• Manage laboratory investigations, change controls, and CAPAs for relevant QC operations
• Troubleshoot issues related to laboratory procedures and assay performance
• Manage internal and external testing schedules to ensure on-time results provided for release and stability requirements
• Collaborate with development teams for method transfer and qualification activities as required
• Support preparation and coordination activities for internal audits and regulatory inspections
• Evaluate suppliers via audits, testing, and review of quality performance
• Contribute to departmental budget and resource allocation
• Prepare and monitor metrics to ensure control of systems and drive continuous improvements
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Execute special projects as necessary to support various business initiatives

Minimum Qualifications:

• Bachelor’s degree in a relevant scientific discipline required
• Fifteen (15) years of cGMP QC experience in biotechnology/large molecule industry strongly preferred
• Five (5) years in roles of increasing QC management experience
• Strong understanding of QC principles, USP/Ph Eur compendia testing requirements and various testing techniques
• Experience in method transfer and qualification/validation activities
• Demonstrated troubleshooting and problem-solving skills
• Excellent written, and verbal communication skills

• Dedicated team player who is able to withstand the high demands of a fast-paced environment
• Comfortable working independently with minimal supervision
• Highly organized, results driven, problem solver, collaborator
• Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to human.resources@tonixpharma.com and include Quality Control Director in the subject of the email. 

About Tonix:

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharm.com for specifics on the pipeline.

Position Overview:

Tonix is looking for a full-time Executive Assistant to effectively provide quality support mainly to Tonix’ CEO. The candidate should have a bachelor’s degree and at least 3 years’ experience or equivalent in supporting C level executives.  This is a fast-paced challenging position offers a competitive compensation and benefits package. The position would be based in Tonix’ South Dartmouth, MA office.  

Reporting to the CEO, the Executive Assistant is responsible for collaborating with our CEO to effectively provide support and provide efficiencies for them in regard to travel and calendaring as well as general administrative support needed to successfully run the company.

Essential Duties

• Managing the executive's day-to-day calendar, including making appointments and prioritizing the most sensitive matters
• Organizing meetings, including scheduling, sending reminders, and organizing catering and AV when necessary
• Coordinating travel arrangements (both domestic and international) and create trip itineraries
• Assist with filtering, prioritizing and overall management of emails
• Providing administrative assistance, such as writing and editing emails, drafting memos, and preparing communications on the executive's behalf
• Maintaining comprehensive and accurate corporate records, documents, and reports
• Using various software, specifically MS Office Suite, including word, spreadsheets, and presentation software to prepare reports and/or special projects
• Ensuring the executive has any tools or supplies needed to perform their duties
• Upholding company mission and values through accountability, innovation, integrity, quality, and teamwork
• Performing other ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

• Bachelor’s degree with 3 years of experience or at least 5 years of relevant experience preferred
• Knowledge of the life sciences industry preferred
• IAAP Certified Administrative Professional (CAP), or similar certification preferred
• Demonstrated ability to quickly develop and maintain strong relationships with internal customers and external vendors
• Superior time management skills with the ability to multitask and meet tight deadlines
• Comfortable working independently with minimal supervision
• Highly organized, results driven, problem solver, decision maker, collaborator
• Ability to act as gatekeeper and escalate relevant information to executives as needed
• Ability to treat confidential information with appropriate discretion
• Exceptional attention to detail
• Dedicated team player who can withstand the high demands of a fast-paced environment
• Excellent written, organizational, and verbal communication skills
• Skilled in the use of standard office equipment (e.g., copiers, business telephone systems, projectors, fax machines).
• Proficient in MS Office Suite
• Ability to travel minimally as needed
• Available for client work and/or travel Monday through Friday on a general basis, including outside of normal business hours and weekends
• Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to human.resources@tonixpharma.com and include Executive Assistant in the subject of the email. 

About Tonix

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview

Tonix is looking for a Facility Maintenance Scheduler/Planner to support a growing life science facility located in New Bedford Business Park (Dartmouth, MA).  The individual in this position functions as a key central team member of the Facilities and Engineering team coordinating all maintenance and metrology activities across the site.  The individual will be the primary system owner for the Computerized Maintenance and Metrology System (CMMS) managing all internal and contract service activities. The individual will work closely the Procurement Team to ensure all maintenance service contracts are in place to support planned and unplanned activities to keep the facility at full operational capacity.

This is a fast-paced challenging position offering a competitive compensation and benefits package. This position will report directly to the Facilities Manager and will be based in the Tonix Advanced Development Centre (ADC) facility in North Dartmouth, MA once open and operational in Q1, 2022.  Remote work arrangements will be in place until such time. 

Essential Duties

• Lead efforts to improve overall maintenance program effectiveness through continuously improving preventive maintenance strategy
• Robust understanding on how to fully utilize a Computerized Maintenance Management System (CMMS)
• Responsible for the Maintenance program for day-to-day activities and determine preventative maintenance frequencies on a daily, weekly, and monthly basis utilizing CMMS and other tools
• Responsible for the planning, scheduling, and performance of the calibration program
• Work directly with Facilities, Engineering, Metrology, Validation, Quality Control, and Quality Assurance in order to support company needs
• Comply with all account CMMS standards and specifications to ensure database integrity and standardization
• Develop CMMS training materials and conduct trainings
• Optimize the maintenance inventory by balancing work load by time period and available labor
• Support parts and material procurement tasks, associate material to job plans for auto orders, and work with engineering to optimize maintenance schedule
• Review and prioritize requests, determine activities required for completion of work and sets completion date
• Coordinate with client representatives to understand their needs and to ensure the work schedule takes account of the downtime windows negotiated with clients
• Track KPI metrics for work completed past due, labor hours, inspections and asset costs
• Analyze metrics from the CMMS to improve uptime and reduce costs and maintain quality data
• Conduct monthly building audits
• Comply with all safety, security, company policies and procedures
• Create and run various work order metrics reports as needed

Minimum Qualifications

• CMMS experience including working with work order execution and preventive maintenance planning/scheduling
• Facility maintenance background including understanding of HVAC components, electrical, plumbing, and fire sprinkler systems
• High school diploma or equivalent required
• Experience in scheduling work teams with CMMS systems
• Excellent interpersonal communications skills
• Able to interact with all levels of the organization, outside contractors, and engineers
• Proficient in Microsoft Office products (Outlook, Word, Excel, etc.)

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to human.resources@tonixpharma.com and include Facility Maintenance Scheduler/Planner in the subject of the email. 

About Tonix

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview

Based on the expansion of its R&D platform and clinical pipeline, Tonix is looking for an Analytical Development Subject Matter Expert and Leader to supplement its internal and external teams. The Associate Director Analytical Development will be responsible for developing methods designed at characterizing and/or measuring the critical quality attributes (CQAs) of viral vaccine products.  The Associate Director will also be responsible for planning and execution of internal and external analytical development activities across the portfolio of Tonix viral products and leading a small team of scientists located at the Tonix’ Advanced Development Centre (ADC) facility.

The ideal candidate will be a highly motivated individual with experience in analytical development for viral products and interest in working in both a virtual and onsite role, in an entrepreneurial environment with broad responsibilities and opportunities.

This is a fast-paced challenging position offering a competitive compensation and benefits package. This position will report directly to the Executive Director, CMC.

Tonix is currently constructing the Advanced Development Centre (ADC) facility which will be ready for commissioning in North Dartmouth, MA in Q1, 2022. The position will be based in the Tonix ADC facility once open and operational. Remote work arrangements will be in place until such time. 

Essential Duties

• Lead projects associated with establishing robust and compliant analytical test methods
• Own and maintain the knowledge and history of method development and qualification throughout the method and product lifecycle
• Prepare and review technical documents such as test method SOPs, product specifications, qualification and test protocols, technical reports, sampling plans, risk assessments, and/or relevant sections for regulatory submission files
• Provide first line technical support to QC and development testing laboratories in compliance with relevant instructions and quality requirements
• Design new analytical methods or refine existing ones
• Lead method transfers from internal (discovery) or external (CDMO) laboratories, method optimization and qualification
• Personally contribute and lead teams developing viral products release and characterisation methods including biophysical and cell-based assays; including, but not limited to HPLC/UPLC methods, LC-MS/MS methods, particle characterisation methods (AUC, DLS, NTA, Flow virometry), PCR, ddPCR, qPCR, NGS, ELISA, cell based potency assays
• Lead the transfer of developed methods and acquired knowledge to the Quality Control team
• Author and reviewing analytical test methods, data summaries, protocols, and technical reports
• Engage with internal and external stakeholders/customers to set strategic goals, generate workplans, and discuss findings
• Use scientifically sound rational and statistical tools for data analysis, contribute to enhancing process understanding and identifying key sources of variability and root causes of product and process failures
• Support change review and implementation, quality investigations, CAPAs in cross-functional teams
• Participate in the definition and selection of analytical instruments by providing input to User Requirement Specifications (URS) and creating associated procedures
• Support instrument qualification activities
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Leadership Duites

• Provide guidance and training to direct reports as relates to assigned projects and consistent with the quality governance
• Develop work and project plans and execute per the plans
• Provide input into development of budgets proposals, new capital expenditures, recruitment planning and external spending
• Accountable for on-time project completion and achievement of compliance goals
• Represent the CMC Development function in project team meetings

Minimum Qualifications

• PhD in Biochemistry, Analytical Chemistry, or related discipline with eight (8) years of industry experience in Analytical Development
• Experience developing methods for viral vaccines, viral products or gene therapy
• Experience with Biochemical, Physicochemical and/or Biologic activity methods
• Project management experience
• Experience in experimental design and statistical analysis methodology
• Experience with projects in clinical development (e.g. Phase 1 through Phase 3)
• Experience with cGMP manufacturing and regulatory submissions
• Ability to identify and resolve critical issues
• Excellent written and verbal communication skills, good interpersonal and stakeholder management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators)
• Demonstrated ability to develop methods to characterize or measure the CQAs of in-process and release samples
• Experience with the following techniques: ELISA, gel electrophoresis, DLS, DSC, AUC, and capillary electrophoresis (CE-SDS, cLIF, cIEF)
• Dedicated team player who is able to withstand the high demands of a fast-paced environment
• Excellent written, organizational, and verbal communication skills are essential
• Strong planning and organizational skills
• Comfortable working independently with minimal supervision
• Highly organized, results driven, problem solver, collaborator
• Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to human.resources@tonixpharma.com and include Associate Director, Analytical Development in the subject of the email. 

About Tonix

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview

Based on the expansion of its R&D platform and clinical pipeline, Tonix is looking for a Downstream Process Development Subject Matter Expert and Group Lead to supplement its internal and external teams. The Process Development Group Lead will be responsible for planning and execution of internal and external process development activities across the portfolio of Tonix viral vaccine products and leading a small team of scientists and engineers located at the Tonix Advanced Development Centre (ADC) facility.

The ideal candidate will be a highly motivated individual with experience in downstream development for viral products and interest in working in both a virtual and onsite role, in an entrepreneurial environment with broad responsibilities and opportunities.

This is a fast-paced challenging position offering a competitive compensation and benefits package. This position will report directly to the Executive Director, CMC.

Tonix is currently constructing the Advanced Development Centre (ADC) facility which will be ready for commissioning in North Dartmouth, MA in Q1, 2022. The position will be based in the Tonix ADC facility once open and operational. Remote work arrangements will be in place until such time. 

Essential Duties

• Lead projects associated with establishing robust and compliant manufacturing processes at Tonix through defining the manufacturing process and associated control strategy
• Own and maintain the knowledge and history of manufacturing processes throughout the product lifecycle
• Prepare and review technical documents such as batch records, sampling plans, process related and analytical method SOPs, risk assessments, study protocols, technical reports, and/or relevant sections for regulatory submission files
• Provide first line technical support to manufacturing in compliance with relevant instructions and quality requirements
• Lead process characterization, scale up, process optimization, and process validation
• Use scientifically sound rational and statistical tools for data analysis, contribute to enhancing process understanding and identifying key sources of variability and root causes of product and process failures
• Support change review and implementation, quality investigations, and CAPAs in cross-functional teams
• Participate in the definition and selection of equipment by providing input to User Requirement Specifications (URS) and creating associated procedures
• Support process equipment FAT, SAT, and on-site qualification activities
• Deliver robust, scalable, and cost-effective viral vaccine manufacturing processes and product formulations that meet or exceed the target product profile
• Maintain functional lab environment as well as a hands-on contribution in the lab
• Prepare technical reports, publications, and oral presentations
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Leadership

• Provide scientific leadership and manage performance of direct reports
• Provide guidance and training to direct reports as relates to assigned projects and consistent with the quality governance
• Develop work and project plans and execute per the plans
• Provide input into development of budgets proposals, new capital expenditures, recruitment planning and external spending
• Accountable for on-time project completion and achievement of compliance goals
• Represent the CMC Development function in project team meetings

Minimum Qualifications

• PhD in Biochemistry, Chemical Engineering, Microbiology, Biotechnology, or related scientific discipline with 8+ years of experience in biotechnology industry
• Biopharmaceutical development experience specifically in the area of viral vaccines and viral-based products required; monoclonal antibodies development is an asset
• Broad experience with purification technologies for viral products, drug substance formulation, and fill/finish
• Experience leading projects
• Experience in experimental design and statistical analysis methodology
• Experience with projects in clinical development (e.g. Phase 1 through Phase 3)
• Experience with cGMP manufacturing and regulatory submissions
• Ability to identify and resolve critical issues
• Dedicated team player who is able to withstand the high demands of a fast-paced environment
• Excellent written, organizational, and verbal communication skills are essential
• Strong planning and organizational skills
• Comfortable working independently with minimal supervision
• Highly organized, results driven, problem solver, collaborator
• Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to human.resources@tonixpharma.com and include Group Lead, Dowstream Process Development in the subject of the email. 

About Tonix

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview

Based on the expansion of its R&D platform and clinical pipeline, Tonix is looking for an Upstream Process Development Subject Matter Expert and Group Lead to supplement its internal and external teams. The Process Development Group Lead will be responsible for planning and execution of internal and external process development activities across the portfolio of Tonix viral vaccine products and leading a small team of scientists and engineers located at the Tonix Advanced Development Centre (ADC) facility.

The ideal candidate will be a highly motivated individual with experience in upstream development for viral products and interest in working in both a virtual and onsite role, in an entrepreneurial environment with broad responsibilities and opportunities.

This is a fast-paced challenging position offering a competitive compensation and benefits package. This position will report directly to the Executive Director, CMC.

Tonix is currently constructing the Advanced Development Centre (ADC) facility which will be ready for commissioning in North Dartmouth, MA in Q1, 2022. The position will be based in the Tonix ADC facility once open and operational. Remote work arrangements will be in place until such time. 

Essential Duties

• Lead projects associated with establishing robust and compliant manufacturing processes at Tonix through defining the manufacturing process and associated control strategy
• Own and maintain the knowledge and history of manufacturing processes throughout the product lifecycle
• Prepare and review technical documents such as batch records, sampling plans, process related and analytical method SOPs, risk assessments, study protocols, technical reports, and/or relevant sections for regulatory submission files
• Provide first line technical support to manufacturing in compliance with relevant instructions and quality requirements
• Lead process characterization, scale up, process optimization, and process validation
• Use scientifically sound rational and statistical tools for data analysis, contribute to enhancing process understanding and identifying key sources of variability and root causes of product and process failures
• Support change review and implementation, quality investigations, and CAPAs in cross-functional teams
• Participate in the definition and selection of equipment by providing input to User Requirement Specifications (URS) and creating associated procedures
• Support process equipment FAT, SAT, and on-site qualification activities
• Deliver robust, scalable, and cost-effective viral vaccine manufacturing processes and product formulations that meet or exceed the target product profile
• Maintain functional lab environment as well as a hands-on contribution in the lab
• Prepare technical reports, publications, and oral presentations
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Leadership

• Provide scientific leadership and manage performance of direct reports
• Provide guidance and training to direct reports as relates to assigned projects and consistent with the quality governance
• Develop work and project plans and execute per the plans
• Provide input into development of budgets proposals, new capital expenditures, recruitment planning and external spending
• Accountable for on-time project completion and achievement of compliance goals
• Represent the CMC Development function in project team meetings

Minimum Qualifications

• PhD in Biochemistry, Chemical Engineering, Microbiology, Biotechnology, or related scientific discipline with 8+ years of experience in biotechnology industry
• Biopharmaceutical development experience specifically in the area of viral vaccines and viral-based products required; monoclonal antibodies development is an asset
• Experience with mammalian cell culture, viral product, cell and viral banking, bioreactor operations, cell separation, and virus primary recovery techniques
• Experience leading projects
• Experience in experimental design and statistical analysis methodology
• Experience with projects in clinical development (e.g., Phase 1 through Phase 3)
• Experience with cGMP manufacturing and regulatory submissions
• Ability to identify and resolve critical issues
• Dedicated team player who is able to withstand the high demands of a fast-paced environment
• Excellent written, organizational, and verbal communication skills are essential
• Strong planning and organizational skills
• Comfortable working independently with minimal supervision
• Highly organized, results driven, problem solver, collaborator
• Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to human.resources@tonixpharma.com and include Group Lead, Upstream Process Development in the subject of the email. 

About Tonix

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview

Based on the expansion of it its Recombinant Pox Vaccine (HPV) Platform, Tonix is looking for a Manager, CMC Development to supplement its internal and external team. The individual in this position will be responsible for planning and execution of process and analytical development activities across the portfolio of Tonix viral vaccine products.

The individual in this position will be highly motivated with experience and interest in working in a small virtual, entrepreneurial environment with broad responsibilities and opportunities.

Tonix is currently constructing its own Advanced Development Centre (ADC) facility which will be ready for commissioning in North Dartmouth, MA in Q1, 2022. The position will be based in the Tonix ADC facility once open and operational. Remote work arrangements will be in place until such time. 

Essential Duties

• Lead projects associated with establishing robust and compliant manufacturing processes at Tonix through defining the manufacturing process and associated control strategy
• Own and maintain the knowledge and history of Tonix manufacturing processes throughout the product lifecycle
• Prepare and review of technical documents such as batch records, sampling plans, process related and analytical method SOPs, risk assessments, study protocols, technical reports, and/or relevant sections for regulatory submission files
• Provide first line technical support to manufacturing in compliance with relevant instructions and quality requirements
• Lead process characterization and scale up, process optimization, and process validation
• Use scientifically sound rational and statistical tools for data analysis, contribute to enhancing process understanding and identifying key sources of variability and root causes of product and process failures
• Support change review and implementation, quality investigations, and CAPAs in cross-functional teams
• Participate in the definition and selection of equipment, through providing input to User Requirements Specifications (URS) and creating associated procedures
• Deliver robust, scalable, and cost-effective manufacturing processes and product formulations that meet or exceed the target product profile
• Project product needs for preclinical and clinical programs, working within associated budgets
• In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CROs and CDMOs are using systems and processes in compliance with all relevant regulatory standards
• Prepare and present technical reports, publications, and oral presentations
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Leadership Duties

• Provide leadership, guidance, and direction consistent with the quality governance, to associates across sites and functions as relates to assigned projects
• Provide coaching, training, and mentoring of other associates as applicable, as well as seek and provide feedback
• Develop work and project plans, assign tasks, and oversee execution per the plans
• Review the progress of projects and outcomes to evaluate if changes are required in direction, scope, time, labor, or staff
• Ensure that projects are completed on schedule and within budget
• Provide input into development of budgets proposals, new capital expenditures, recruitment planning, and external spending
• Accountable for achievement of compliance goals
• Represent department in project team meetings
• Address or escalate compliance issues

Minimum Qualifications

• Bachelor’s degree in biochemistry, chemical engineering, microbiology, biotechnology, or related discipline with ten (10) years’ experience or Master’s/PhD with five years’ experience in the biotechnology industry preferred
• Advanced expertise in mammalian cell / viral culture, bioreactor operations, and related techniques
• Project management experience
• Experience in experimental design and statistical analysis methodology
• Experience with cell and gene therapy products and processes preferred
• Experience with projects in clinical development e.g., Phase 1 through Phase 3
• Biopharmaceutical development experience specifically in the area of viral vaccines and monoclonal antibodies development, upstream, downstream, and filling preferred
• Knowledge of analytical method development and qualification practices
• Experience with cGMP manufacturing and regulatory submissions preferred
• Ability to identify and resolve critical issues
• Experience implementing technical, strategic, and operational plans
• Good interpersonal and stakeholder management skills to collaborate with and direct the work of others on assigned projects, including both internal teams and external collaborators
• Dedicated team player who is able to withstand the high demands of a fast-paced environment
• Excellent written, organizational, and verbal communication skills are essential
• Strong planning and organizational skills
• Comfortable working independently with minimal supervision
• Highly organized, results driven, problem solver, collaborator
• Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to human.resources@tonixpharma.com and include Manager, CMC, Viral Vaccine Development in the subject of the email. 

About Tonix

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview

Based on the expanding portfolio of products in development, Tonix is looking for a Director, CMC Development to supplement its external CMC development team. The individual in this position will be responsible for planning and execution of process and analytical development activities across the portfolio of Tonix products at various CDMOs globally.

The individual in this position will be highly motivated with experience and interest in working in a virtual, entrepreneurial environment with broad responsibilities and opportunities.

Essential Duties

• Identify and select suitable CDMOs for each project phase for both small and large molecules  
• Establish robust and compliant manufacturing processes at the CDMOs through defining the manufacturing process and associated control strategy relevant to the phase of development
• Own and maintain the knowledge and history of Tonix manufacturing processes throughout the product lifecycle
• Prepare, review, and approval of of technical documents such as batch records, sampling plans, process related and analytical method SOPs, risk assessments, study protocols, technical reports, and/or relevant sections for regulatory submission files
• Use scientifically sound rational and statistical tools for data analysis, contribute to enhancing process understanding and identifying key sources of variability and root causes of product and process failures in collaboration with the CDMO team
• Support change review and implementation, quality investigations, and CAPAs in cross-functional teams with the CDMO and Tonix teams
• Deliver robust, scalable, and cost-effective manufacturing processes and product formulations that meet or exceed the target product profile
• Project product needs for preclinical and clinical programs, working within associated budgets
• In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CROs and CDMOs are using systems and processes in compliance with all relevant regulatory standards
• Prepare and present technical reports, publications, and oral presentations
• Provide input and maintain Project Gantts, leading CMC targets and reporting to project management and senior leadership on events as necessary
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Leadership Duties

• Provide leadership, guidance, and direction consistent with the quality governance, to associates across sites and functions as relates to assigned projects
• Provide coaching, training, and mentoring of other associates as applicable, as well as seek and provide feedback
• Develop work and project plans in collaboration with CDMOs, assign tasks, and oversee execution per the plans
• Review the progress of projects and outcomes to evaluate if changes are required in direction, scope, time, labor, or staff or alternate CDMOs
• Ensure that projects are completed on schedule and within budget
• Provide input into development of budgets proposals, recruitment planning, and external spending
• Accountable for achievement of compliance goals
• Represent department in project team meetings
• Address or escalate compliance issues

Minimum Qualifications

• Bachelor’s degree in biochemistry, chemical engineering, microbiology, biotechnology, or related discipline with ten (10) years’ experience or Master’s/PhD with five years’ experience in the biotechnology industry preferred
• Project management experience
• Experience in experimental design and statistical analysis methodology
• Experience with projects in clinical development e.g., Phase 1 through Phase 3
• Knowledge of analytical method development and qualification practices
• Experience with cGMP manufacturing and regulatory submissions preferred
• Ability to identify and resolve critical issues
• Experience implementing technical, strategic, and operational plans
• Good interpersonal and stakeholder management skills to collaborate with and direct the work of others on assigned projects, including both internal teams and external collaborators
• Dedicated team player who is able to withstand the high demands of a fast-paced environment
• Excellent written, organizational, and verbal communication skills are essential
• Strong planning and organizational skills
• Comfortable working independently with minimal supervision
• Highly organized, results driven, problem solver, collaborator
• Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to human.resources@tonixpharma.com and include Director, CMC, Virtual Development in the subject of the email. 

About Tonix

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview

Tonix is looking for a full-time Manager of Health, Safety and Environmental (HSE) to effectively provide oversight of their new Advanced Development Center to be located in the New Bedford Industrial Park, Dartmouth MA. The individual in this position would be responsible for ensuring the health, safety and wellbeing of all employees working in a BSL-2 compliant Vaccine Development facility.  The individual in this position will also be responsible for ensuring compliance with all state, federal, and local environmental codes, and regulations.  The Manager of HSE will support all aspects of this process including strategy development and all consulting and service contracts required to support operations.

This is a fast-paced challenging position offering a competitive compensation and benefits package. This position will report directly to the Director of Facilities and Engineering with an indirect report to the Site Head.

Tonix is currently constructing its own Advanced Development Centre (ADC) facility which will be ready for commissioning in North Dartmouth, MA in Q1, 2022. The position will be based in the Tonix ADC facility once open and operational. Remote work arrangements will be in place until such time. 

Essential Duties

• Provide safety oversight during facility construction including review of Contractors Safety Plans and safety audits in the field
• Participate in the facility design review process including any Process Hazard Reviews (PHR’s)
• Lead site permitting activities for all state and local environmental permits (air emission, wastewater, etc.)
• Develop BSL-2+ compliance program in accordance with the CDC BMBL
• Develop a waste management program for regulated medical waste as well as chemical wastes

• Develop and implement inspection policies and procedures, and a schedule of routine inspections
• Develop health and safety procedures for all ADC operations.
• Prepare and schedule training to cover emergency procedures, workplace safety, and other relevant topics
• Monitor compliance with safety procedures
• Generate inspection reports to document inspection findings
• Ensure that material safety data sheets are maintained and readily accessible when needed
• Maintain records of discharge of employee exposure to hazardous waste and/or pollutants, as required
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

• Bachelor’s degree in Environmental Safety, Occupational Safety and Health, or related field required, Master’s degree desirable
• Five years of life science or related industry experience preferred
• Experience with BSL -2 or greater laboratory safety programs
• Extensive knowledge of environmental regulations and policies
• Excellent analytical and problem-solving skills
• Excellent written and verbal communication skills
• Excellent organizational skills and attention to detail
• Proficient in technology and equipment used in environmental inspections
• Proficient in Microsoft Office Suite or similar software

• Dedicated team player who is able to withstand the high demands of a fast-paced environment
• Comfortable working independently with minimal supervision
• Highly organized, results driven, problem solver, collaborator
• Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to human.resources@tonixpharma.com and include Manager of Health, Safety and Environmental in the subject of the email. 

About Tonix:

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview:

The Manager/Senior Manager, QA Documentation and Training will lead the development and management of the Tonix ADC facility GMP documentation and training programs and processes. The individual in this position will be responsible for managing document lifecycle processes and records retention. Also, this role will establish training requirements and materials to ensure compliance with internal and regulatory standards. This individual will maintain the electronic document and training management systems in support of these activities.

This position will work with the other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate.  Also, this role will also provide the appropriate QA strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities and to ensure a culture of quality and compliance.

The Manager/Senior Manager, QA Documentation and Training reports into the Senior Director of Quality and is a member of the Quality management team at the facility.  The role will be based out of the new facility in North Dartmouth, MA once open and operational, expected in 2022. Remote work arrangements will be in place until such time. 

Essential Duties:

• Oversee cGMP processes related to document control, training programs, and records management
• Manage document lifecycle through creation, editing, review, issuing, and archiving with respect to batch records, test records, SOPs, and quality system records
• Collaborate with departmental management to establish and maintain role-based training curricula and training materials
• Monitor training completion to ensure compliance with procedures
• Train staff in use of electronic document and learning management systems
• Maintain the eDMS and LMS and support required validation activities
• Participate as SME in internal audits as required and assist in preparation for regulatory inspections
• Prepare and monitor metrics to ensure control of systems and drive continuous improvements
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Execute special projects as necessary to support various business initiatives

Minimum Qualifications:

• Bachelor’s Degree in Science or other related discipline or equivalent work experience required
• Eight (8) years of Quality Assurance experience in document control, training and/or quality systems preferred
• Five (5) years performing document control and/or training management preferred
• Comprehensive knowledge of cGMP regulatory requirements relating to employee training and qualification, document control, and records management
• Proficient with Microsoft Office applications (e.g., Word, Excel)
• Experience with eDMS and LMS preferred
• Experience with electronic training content software preferred
• Collaborative, results-driven team player who excels in a dynamic environment
• Excellent organizational, written, and verbal communication skills
• Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to human.resources@tonixpharma.com and include Manager/Senior Manager QA Documentation and Training in the subject of the email. 

About Tonix:

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview:

The Manager/Senior Manager, QA Operations and Compliance will lead the Quality Assurance GMP operations and compliance functions for the organization. The individual in this position will implement and oversee Quality standards and systems related to activities at the GMP Manufacturing facility in North Dartmouth, MA opening in 2022.  Also, this role will support validation execution as well as internal and external manufacturing and testing. The individual in this position will have the unique opportunity to hire and  train employees as well as oversee performance management, mentoring and career development of the team.

This position will work with the other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate.  Also, this role will also provide the appropriate QA strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities and to ensure a culture of quality and compliance.

The Manager/Senior Manager, QA Operations and Compliance reports into the Senior Director of Quality and is a member of the Quality management team at the facility.  The role will be based out of the new facility in North Dartmouth, MA once open and operational, expected in 2022. Remote work arrangements will be in place until such time. 

Essential Duties:

• Oversee day-to-day operations of the Quality Assurance operations and compliance functions
• Manage personnel and oversee their selection, performance management, mentoring, and career development
• Implement and manage key Quality Systems in compliance with applicable quality standards and requirements, including but not limited to risk management, change control, deviations, CAPA, self-inspection, and complaints
• Provide compliance support for internal project teams as well as external contract organizations
• Perform lot release activities including review and approval of master and executed batch records and Certificates of Analyses
• Support review and approval of validation documents (e.g., equipment, computer system validation) in collaboration with cross-functional teams
• Prepare and monitor metrics to ensure control of systems and drive continuous improvements
• Maintain and execute internal audit schedule as well as participate in regulatory audits
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Execute special projects as necessary to support various business initiatives

Minimum Qualifications:

• Bachelor’s Degree in Science or other related discipline or equivalent work experience required
• Eight (8) years of combined experience in a biotechnology/cell and gene therapy environment, covering QA, QC and/or manufacturing preferred
• Prior experience in Quality leadership in the pharmaceutical/biotechnology industries
• Strong foundation in application of cGMPs in a drug substance or drug product manufacturing environment, preferably in FDA and Heath Canada requirements
• Demonstrated troubleshooting and problem-solving skills
• Ability to analyze a wide variety of information and data to make management decisions regarding potential risks associated with regulatory compliance
• Collaborative, results-driven team player who excels in a dynamic environment
• Excellent organizational, written, and verbal communication skills
• Proven aseptic experience and training in cGMP large molecule industry strongly preferred
• Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to human.resources@tonixpharma.com and include Manager/Senior Manager, QA Operations and Compliance in the subject of the email. 

About Tonix:

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview:

Based on the expansion of it its R&D platform, Tonix is looking for a Process Development subject matter expert to supplement its internal and external teams.  The individual in this position will be responsible for planning and execution of process development activities across the portfolio of Tonix viral vaccine products.  The individual in this position will be highly motivated with experience and interest in working in a both a virtual and onsite role, in an entrepreneurial environment with broad responsibilities and opportunities.

Tonix is currently constructing its own Advanced Development Centre (ADC) facility which will be ready for commissioning in North Dartmouth, MA in Q1, 2022. The position will be based in Tonix’ ADC facility once open and operational. Remote work arrangements will be in place until such time. 

Essential Duties:

• Lead projects associated with establishing robust and compliant manufacturing processes at Tonix through defining the manufacturing process and associated control strategy
• Own and maintain the knowledge and history of Tonix manufacturing processes throughout the product lifecycle
• Responsible for preparation and review of technical documents such as batch records, sampling plans, process related and analytical method SOPs, risk assessments, study protocols, and technical reports and/or relevant sections for regulatory submission files
• Provide first line technical support to manufacturing in compliance with relevant instructions and quality requirements
• Lead process characterization, scale up, process optimization, and process validation
• Use scientifically sound rational and statistical tools for data analysis, contribute to enhancing process understanding and identifying key sources of variability and root causes of product and process failures
• Support change review and implementation, quality investigations, and CAPAs in cross-functional teams
• Participate in the definition and selection of equipment by providing input to User Requirement Specifications (URS) and creating associated procedures
• Support process equipment FAT, SAT, and on-site qualification activities
• Deliver robust, scalable, and cost-effective viral vaccine manufacturing processes and product formulations that meet or exceed the target product profile
• Prepare technical reports, publications, and oral presentations
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Leadership Duties:

• Provide guidance and training to associates across sites and functions as relates to assigned projects and consistent with the quality governance
• Develop work and project plans and execute per those plans
• Provide input into development of budgets proposals, new capital expenditures, recruitment planning, and external spending
• Complete projects on-time and achieve compliance goals
• Represent the CMC Development function in project team meetings

Minimum Qualifications:

• Bachelor’s in biochemistry, chemical engineering, microbiology, biotechnology or related discipline with five years of experience in the biotechnology industry; or Masters/PhD with three years of experience in the biotechnology industry or equivalent work experience required
• Experience with mammalian cell /viral culture, bioreactor operations, cell separation and virus purification techniques
• Project management experience
• Experience in experimental design and statistical analysis methodology
• Experience with projects in clinical development e.g., Phase 1 through Phase 3
• Biopharmaceutical development experience specifically in viral vaccines and/or monoclonal antibodies development, upstream, downstream, and filling strongly preferred
• Experience with cGMP manufacturing and regulatory submissions preferred
• Ability to identify and resolve critical issues
• Good interpersonal and stakeholder management skills to collaborate with and direct the work of others on assigned projects, including both internal teams and external collaborators
• Dedicated team player who is able to withstand the high demands of a fast-paced environment
• Excellent written, organizational, and verbal communication skills are essential
• Strong planning and organizational skills
• Comfortable working independently with minimal supervision
• Highly organized, results driven, problem solver, collaborator
• Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to human.resources@tonixpharma.com and include Process Development Scientist/Engineer in the subject of the email. 

About Tonix:

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharm.com for specifics on the pipeline.

Position Overview:

Tonix Pharmaceuticals is searching for a Process Engineer to be a member of our Facilities and Engineering team.  This position will support the engineering design, construction, and commissioning of a phase I/II cGMP manufacturing facility. Upon completion, this position will transition to an operational support role focused on day-to-day manufacturing and facilities equipment and automated system support.  The individual in this position will be responsible for the system ownership and project execution of utilities equipment and automated system integration.  Responsibilities include troubleshooting plant and process equipment, automated systems, managing project execution, executing commissioning and qualification activities, and optimizing process and utilities, equipment within a regulated cGMP facility.  They will be involved in the project lifecycle (conceptual design, specification, design and verification, installation and acceptance, and maintenance) of process and utilities equipment for cGMP production equipment.  They will be asked to develop solutions and best practices for a variety of problems with moderate scope and complexity.  They must be able to work collaboratively with Quality, Manufacturing, Facilities, Product Development, external supply partners, and vendors.

Essential Duties:

Project Support

• Responsible for managing automated system integration by working with external supply partners
• Support equipment engineering testing, commissioning, and qualification activities
• Assist in troubleshooting and remediating exceptions found during process operations and technology transfers
• Define all aspects of project scope and project activities
• Ensure all project documentation is accurate and up to date (P&lDs, mechanical system drawings, automation documentation, etc.)
• Compile and review equipment Engineering Turnover Packages (EToPs) for executed projects
• Work with a cross-functional groups to develop requirements and recommendations for system/equipment modifications
• Organize and lead all aspects of a medium to large size operational projects including scope, schedule, and coordination of activities

Operational Support

• Collaborate with manufacturing personnel regularly about standard practices and procedures for process and utilities equipment/automation design and operation
• Provide technical input to Manufacturing team on SOP changes, Deviations, GMP Investigations and CAPAs
• Regularly interact with process development, manufacturing, quality, facilities, and procurement to proactively address system challenges
• Provide on-call support for all active automated systems, process equipment, and manufacturing activities
• Responsible for addressing safety related design/equipment issues
• Own all aspects of automated system design and process equipment for GMP manufacturing
• Revise equipment designs to meet end-user's needs
• Responsible for troubleshooting activities, equipment design, and specifications for automated systems, equipment and instrumentation
• Determine corrective maintenance actions, collaborates on preventative maintenance, work to identify spare parts for process and utility equipment
• Provide guidance to maintenance personnel and actively participates in the decision making and project execution of process and/or design improvement
• Own and ensure timely closure of equipment corrective and preventative actions

Documentation, Standards and Templates

• Write, review, and approve equipment specifications, engineering procedures and protocols
• Assist in the revision of manufacturing documentation (SOPs, BR, etc.)
• Actively manage engineering documentation and drawing, as well as coordinating and executing redlines and revisions as applicable

• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Minimum Qualifications

• Bachelor’s degree in Chemical/Mechanical Engineering or other related discipline or ten (10) years related work experience required; alternatively, a Masters degree in Chemical/Mechanical Engineering or other related discipline plus one (1) year related work experience required
• Minimum 3-5 years of experience in a cGMP engineering environment
• Experience in engineering, facility design, automation, or related disciplines
• Frequent use and general knowledge of industry practices, techniques, and standards
• Able to accommodate rapidly changing priorities and deadlines
• Must be a team player able to embrace a team-based culture
• Proficiency with Microsoft Office products and ability to learn additional software applications, as needed
• Hands-on expertise with bioprocess engineering and automated systems
• Familiar with biotechnology process equipment
• Competent with domestic and international GMP regulations
• Demonstrates the ability to work independently to solve complex process and equipment problems
• Capable of establishing working relationships with internal departments and external supply partners
• Dedicated team player who is able to withstand the high demands of a fast-paced environment
• Excellent written, organizational, and verbal communication skills are essential
• Strong planning and organizational skills
• Comfortable working independently with minimal supervision
• Highly organized, results driven, problem solver, collaborator
• Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package.  Please send your resume and cover letter to human.resources@tonixpharma.com and include Process Engineer II in the subject of the email. 

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.

About Tonix

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit www.Tonixpharma.com for specifics on the pipeline.

Position Overview

The Specialist,  QA Documentation and Training will support the development and management of the Tonix ADC facility GMP documentation and training programs and processes. The individual in this position will be responsible for managing document lifecycle processes and records retention. Also, this role will assist in establishing training requirements and materials to ensure compliance with internal and regulatory standards.

This position will work with the other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate. Also, this role will provide support for the appropriate QA strategic planning of continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities and to ensure a culture of quality and compliance.

The Specialist, QA Documentation and Training reports into the Manager of Documentation and Training and is a member of the Quality team at the facility. The role will be based out of the new facility in North Dartmouth, MA once open and operational, expected in 2022. Remote work arrangements will be in place until such time.

Essential Duties

• Support cGMP processes related to document control, training programs, and records management
• Manage document lifecycle through creation, editing, review, issuing, and archiving with respect to batch records, test records, SOPs, and quality system records
• Assist in maintaining role-based training curricula and training materials
• Monitor training completion to ensure compliance with procedures
• Train staff in use of electronic document and learning management systems
• Ensure that records are maintained, secure, and retrievable throughout defined record retention periods
• Issue batch records and master production records to manufacturing
• Support internal audits as required and assist in preparation for regulatory inspections
• Prepare and monitor metrics to ensure control of systems and drive continuous improvements
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Execute special projects as necessary to support various business initiatives

Minimum Qualifications

• Associate degree in science or other related discipline or equivalent work experience preferred
• Three (3) years performing document control and/or training management preferred
• Knowledge of cGMP regulatory requirements relating to employee training and qualification, document control, and records management
• Proficient with Microsoft Office applications (e.g., Word, Excel)
• Experience with eDMS and LMS preferred
• Experience with electronic training content software preferred
• Collaborative, results-driven team player who excels in a dynamic environment
• Dedicated team player who is able to withstand the high demands of a fast-paced environment
• Strong written, organizational, and verbal communication skills are essential
• Strong planning and organizational skills
• Comfortable working independently with minimal supervision
• Demonstrated ability to perform the essential duties of the position with or without accommodation

Tonix offers salary commensurate with experience and an excellent benefits package. Please send your resume and cover letter to human.resources@tonixpharma.com and include Specialist, QA Documentation & Training  in the subject of the email.