Tonix Pharmaceuticals is enrolling participants in a Phase 3 trial for fibromyalgia, the RALLY study.
For more information, please visit www.RALLYStudy.com or www.clinicaltrials.gov (NCT04508621).

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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 Administrative Assistant to effectively provide quality support mainly to Tonix’ CEO, but also other firm executives and management. 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’ Chatham, NJ office.  

 

Reporting to the Head of HR, the Administrative Assistant is responsible for collaborating with our executive management team to effectively provide support and efficiencies for the company. The Administrative Assistant will support all aspects of this process including scheduling, travel planning and office administration.

Essential Duties

  • 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
  • Organizing meetings, including scheduling, sending reminders, and organizing catering and AV when necessary
  • Answering incoming phone calls in a polite and professional manner and accurately taking messages
  • Welcoming visitors and identifying the purpose of their visit before directing them to the appropriate department
  • Managing the executive's day-to-day calendar, including making appointments and prioritizing the most sensitive matters
  • Coordinating travel arrangements (both domestic and international) and create trip itineraries
  • Using various software, including word processing, spreadsheets, and presentation software to prepare reports and/or special projects
  • Maintaining and ordering of office supplies
  • Handling office mail and correspondence as well as outgoing / incoming packages as needed
  • 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 Administrative 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:

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 New Bedford, MA in Q1, 2022. The position will be based in this New Bedford 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. 

Overall responsibilities of a Clinical Program Manager (CPM) at Tonix Pharmaceuticals include:

  • Being the primary contact and leader of all clinical activities for a given study or program
  • Working with the Tonix Director of Clinical Operations and Tonix’s internal departments – Medical, Statistics, Regulatory, Quality Assurance and CMC – to ensure projects are run on time and on budget yet maintaining high quality
  • Managing CRO’s and other vendors to ensure all functions of a study or program are running as contracted.
  • Reporting program and/or study progress to management at specified (weekly/monthly) time points.
  • Attending general management meetings and on occasion attending industry conferences.
  • Assisting with conference presentations or posters when needed

Specific responsibilities of the CPM include:

  • Assisting with protocol and/or program design
  • Identifying CRO’s/vendors, negotiating contracts and setting up expectations
  • Preparing study plans and manuals for study start up
  • Developing recruitment plans and working with recruitment vendors
  • Organizing Investigator Meetings
  • Communicate study procedures and methods in clear manner to all parties
  • Assuring study supplies (labs, study medications, etc.) are delivered to sites on time
  • Approve site regulatory packages for initial drug shipments
  • Overseeing study progress, including recruitment, monitoring and data cleaning
  • Managing vendor budgets and approving payments; ensuring work is being done on time
  • Reviewing data on an ongoing basis to ensure database locks occur on time
  • Assisting with final statistical table and listing reviews; preparing charts when needed 

Job Requirements

Specific requirements include:

  • Bachelor’s degree in science and at least 10 years of experience in randomized clinical trials in central nervous system indications
  • Advanced degree in health science, such as MA, MS, M.Pharm, RN, MPH, preferred
  • Prior experience in the role of program or project manager for trial(s) of preventative (prophylactic) migraine small molecule or biologic therapeutics
  • Good medical writing skills for study protocols, consent forms, clinical study reports, grant applications, etc.
  • Highly organized with excellent communication skills
  • Able to carry out CPM responsibilities in the migraine space with little supervision, yet works well with a multiple disciplinary internal clinical team as well in the management of 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 Program Manager 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. 

 

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.

Tonix is looking for a full-time director to effectively provide quality oversight and support across all clinical programs. The candidate should have 10+ years in industry clinical GCP QA setting, with QA experience in early and late phase drug development, as well as drug approval experience in the U.S.  This is a fast-paced challenging position offering a competitive compensation and benefits package. The position will be based at the Company’s Chatham, NJ office.

Job Responsibilities:

  • Develop, implement and maintain GCP quality oversight systems through development of procedures that follow 21 CFR Part 50, 56 and 312 along with ICH E6 and other relevant guidance documents
  • Develop and implement full contract research organization (CRO) and clinical site qualification program through development of GCP auditing system, including auditing/managing QA audits of clinical database and QA regulatory submissions, e.g., Investigator’s Brochure, Clinical Study Reports and IND/NDA
  • Develop and manage company SOPs system including employee training and authoring of clinical and QA related SOPs
  • Participate in the development of clinical site training systems and site certifications related to EDC/ eCRF and training of standardized rating processes
  • Collaborate with the Clinical Operations team, CROs and sites to effectively and efficiently implement the overall GCP oversight programs
  • Represent clinical QA in selecting and managing clinical trial material (CTM) packaging and labeling (P&L) service provider and actively participate in scheduled
  • Perform risk analysis on any GCP violation reported from the clinical site or CROs (including CTM service provider) for planned or unplanned deviation
  • Maintain study drug unblinding information to facilitate emergency unblinding need
  • Provide active monitoring of vendors and clinical investigators regulatory inspections history and activities (FDA, EMEA, etc.)
  • Conduct and/or manage contract GCP audit and develop GCP auditing plan for all ongoing and completed clinical studies
  • Develop and provide independent periodic reports to management on overall compliance status
  • Contribute in the review and authoring of the Quality and Safety Agreement with partnering company and participate in the company Quality Manual development
  • Provides expertise and guidance in interpreting government regulations and guidelines, both US and ROW relating to clinical trials
  • Provide updates at clinical team and regulatory team meetings
  • Other QA related duties as assigned

Requirements:

  • Bachelor degree or advanced degree in a scientific, clinical or related discipline
  • At least 10 years of experience in an industry clinical setting in a GCP quality role and as a Clinical Research Manager, with at least 5 years leading the GCP and quality function
  • Experience in working for a company that has developed at least one product and received FDA approval.
  • Experience in GCP audits either through performing audits or being the recipient of the audit
  • Experience in hosting PAI and developing the QA NDA/BLA summary
  • Experience in clinical trials with drugs and biologics for chronic pain, CNS and/or immunology indications an asset
  • Appreciation of the US regulatory drugs and/or biologics approval process
  • Proficient in MS Word, Excel, Power Point and working in Cloud computing environment, i.e., MS SharePoint
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Outstanding people manager with good listening skills, interpersonal savvy, and peer relations
  • Expert understanding in the effective management of modern quality systems
  • When safe and feasible, willing to travel at least 50% of the time

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 of Quality Assurance/ GCP Compliance” in the subject line 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 or genetics. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. 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, or veteran status. Improper interference with the ability of Tonix’s employees to perform their job duties may result in discipline up to and including discharge

Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).  The Company is focused on discovering 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 CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. Please visit www.Tonixpharma.com for more information.

Tonix is looking for a full-time Director, Corporate Controller.  In this position, you will be responsible for our accounting operations and consolidated financial statements. You will be part of a global finance team and lead our technical accounting, reporting, and financial controls teams, and will be closely involved in the oversight of our accounting operations teams in the US and Ireland. In this role you will bring strong leadership skills and an expertise in U.S. GAAP to provide insightful solutions in our exciting, fast-paced environment. You will partner closely with others across our organization to add valuable insights that help drive business decisions.

The successful candidate will be results-oriented with excellent communication and technical accounting skills, able to leverage mutually beneficial cross-functional relationships and experienced in managing the consolidated accounting and finance operations for a multinational life sciences company. Candidates will have strong inter-personal skills and will have the ability to flex their management style to effectively manage our diverse workforce. They will be highly organized and will be an effective multi-tasker with the ability to prioritize key initiatives, with strong attention to detail and a dedication to quality in everything they do. The successful candidate will be able to articulate complex accounting items in a summarized manner for external auditors and executive leadership team.

This is a fast-paced challenging position offering a competitive compensation and benefits package. This position will report directly to the Chief Financial Officer and will be based at the Company’s Chatham, NJ office headquarters.

Responsibilities: 

  • Responsible for managing the monthly & quarterly accounting closes, including overseeing accounting practices of our foreign subsidiary
  • Manages day-to-day accounting, including general ledger & monthly journal entries and supporting documentation
  • Manages complex account reconciliations (stock comp, intercompany, leases, construction in progress, consolidations)
  • Manages financial reporting & financial statement issuance
  • Manages technical accounting memos & models
  • Recommends, designs, & implements internal control framework
  • Recommends & implements any new accounting systems/applications for accounting & forecasting
  • Manages the external audit process
  • Manages the integration with our foreign subsidiary accounting processes
  • Manages tax strategy/compliance (including federal & state filings & ongoing tax compliance matters)
  • Ensure compliance with US Sarbanes Oxley regulations.

 Minimum Qualifications:

  • Bachelor’s degree in accounting or finance or related field
  • 10 + years of relevant experience, with combination of big 4 public accounting and industry experience within a life science or pharmaceutical organizations preferred
  • Thorough working knowledge of US GAAP accounting & reporting requirements
  • CPA required
  • Experience working with a foreign subsidiary preferred
  • Strong technical skills with Excel, Word, & PowerPoint (experience with Great Plains accounting system strongly preferred)

 Location: Chatham, New Jersey

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.

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 Corporate Controller 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 Director, Quality Systems & Operations will play a key leadership role in ensuring high quality/regulatory compliance during the cGMP manufacturing process for both internal and external programs. The external programs, in strategic partnership with our global service providers (e.g., CDMO’s). The internal programs at our newly created Advanced Development Center (ADC) in New Bedford, MA. The individual in this position will be overseeing the buildout, set-up and operation of the facility that has an expected opening in 2022. The individual in this position will have the unique opportunity to help grow and shape the Tonix QA and QC teams at the New Bedford MA site, evolving the company’s Quality Management System (QMS), and supporting CMC regulatory processes, globally.

This position will also provide QA oversight to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate.  In addition, this position will be responsible for the Quality Control functions at the site. The position will also provide strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities and ensures a culture of quality and compliance.

The position will be based in Tonix’ New Bedford, MA facility once open and operational. Remote work arrangements will be in place until such time. 

 

Essential Duties

  • Provide strategic leadership for Quality Systems & Operations at Tonix in support of Good Manufacturing Practices (GMPs) at our CDMO partners
  • Provide strategic Quality buildout oversight (design, construction, and preparation) of Tonix new viral vaccine manufacturing site in New Bedford, Massachusetts opening in 2022
  • Responsible for building the QA and QC teams responsible for providing Quality oversight of the PD/clinical operations at the New Bedford manufacturing site
  • Responsible for site validation, equipment validation, and operations validation in the New Bedford facility in corporation with cross functional departments
  • Provide independent oversight and compliance direction with authority for QA, Quality oversight and product disposition
  • Recruit, hire, train and mentor future QA and QC staff; provide company-wide training as needed
  • Drive process and product quality through effective virtual Quality systems, ensuring adequate supplier oversight/surveillance
  • Approve Protocol and Reports, Master Batch Records and Executed Batch Records at the CDMO and the CROs for Filling and Packaging
  • Ensure that all necessary steps are added to the Process Control Strategy
  • Review and verify process data to assure compliance with data integrity and traceability regulatory requirements as appropriate
  • Disposition (approve/reject) batches for release
  • Responsible for all QC laboratory functions (raw materials, intermediates and final product testing and release)
  • Ensure that Tonix and its partners are inspection-ready for health authority audits by regulatory agencies, lead engagements with health authorities
  • Assist in preparation and review of regulatory filings and safety data (e.g., INDs, BLAs, Annual Reports); ensure compliance with regulatory procedures
  • Oversee development and maintenance of internal manufacturing and operational SOPs related to GxP activities, with primary focus on cGMP regulations
  • Ensure that all products manufactured meet the registration and cGMP requirements based on global regulatory requirements
  • Responsible for driving efficiencies and supporting the overall manufacturing process including process development activities, drug substance formulation and drug product manufacturing (filling, labelling, packaging, and distribution)
  • Utilize GMP-regulated quality management systems and eQMS, including document control, change control, deviations/complaints, DS/DP release and CAPAs
  • Coordinate with other departments within Tonix to establish a robust QMS
  • Provide direct oversight of activities related to participation in U.S. FDA (CBER) and other regulatory agency inspections
  • Perform other quality-related responsibilities, 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

 

Minimum Qualifications

  • Bachelor’s degree in biology, chemistry, engineering, or other related discipline or equivalent work experience required
  • Ten (10) years of GxP leadership in Quality Assurance (QA) with substantial operational experience; cGMP large molecule expertise required
  • Five (5) years in roles of increasing management responsibility in a biopharmaceutical environment
  • Two (2) years managing Phase 1-3 clinical trials manufacturing; commercial experience optimal.
  • Experience interacting with FDA and global regulatory bodies/health authorities; pre-approval readiness (PAI) for commercial manufacturing preferred
  • Experience in viral vaccine CMC environment and BSL2 operations is strongly preferred
  • Experience in leading and managing complex projects/teams within corporate objectives and project timelines and participating in cross-functional projects as a Quality expert and leader role
  • 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 Head of Quality 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 Head of/Director to supplement its CMC internal and external team of Tonix viral vaccine products.  The individual in this position will be responsible for CMC-related activities across the portfolio, specifically for large molecules and viral vaccine platform including Upstream, Downstream, Formulation and Filling for supply of clinical trial materials, Phase I-III.

 

The individual in this position will be highly motivated with experience and interest in working in both virtual (CDMO) and onsite locations, as well as in an entrepreneurial environment with broad responsibilities and opportunities.

 

The position is one of the lead roles at Tonix’s new Advanced Development Centre (ADC) in New Bedford MA expected to open early 2022, will lead a team of discovery, development, and manufacturing on site. This facility will be the hub and main location for advancement going forward specifically for all viral vaccine development.

 

Essential Duties

  • Identification, selection, and management of Contract Development Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of ongoing clinical programs for all Tonix viral vaccine programs
  • Develop and implement strategy with the team for the Design of Experimentation (DOE) for optimizing and controlling quality of bulk DS and DP using CROs and CDMOs
  • Deliver robust, scalable, and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile
  • Projection of DS and DP needs for preclinical and clinical programs (with clinical team), and associated budgets (with finance team)
  • Formulation design and development for clinical programs
  • Manage supply chain and logistics in support of clinical studies
  • In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards
  • Execute plans for the validation and registration of DS and DP as required by cGMP, ICH, and FDA regulations
  • Write and review documents for INDs / regulatory section submissions
  • Represent the company as the CMC expert before U.S. and European regulatory authorities
  • Prepare, review, or edit cGMP batch records, CMC regulatory and Quality documents
  • 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

 

Minimum Qualifications

  • PhD or MS with 10+ years of experience; advanced degree in pharmaceutical chemistry, organic chemistry, pharmaceutics, pharmaceutical science, or related] scientific discipline or equivalent education/work experience required
  • Experience in managing US and International CRO/CDMOs for the manufacture of cGMP DS and DPs
  • 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 strongly preferred
  • Advanced expertise in mammalian cell /viral culture, bioreactor operations and related techniques strongly preferred
  • Experience with cGMP manufacturing and IND, CTA, and NDA filings
  • Thorough knowledge of relevant FDA and EMEA regulations
  • Ten years relevant experience in a biotechnology CMC/cGMP environment
  • Experience in supply chain management
  • Able to identify and resolve critical issues
  • Experience implementing technical, strategic, and operational plans
  • Exceptional interpersonal and 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/Product Development/Tech Ops 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 individual in this position is responsible for ensuring the uptime, availability, and performance of all facilities/infrastructure systems as well as the associated service contracts to support on-going Product Development and GMP Clinical Manufacturing

 activities.  The individual in this position will ensure that all facility systems and programs, GMP and non-GMP, conform to relevant code, regulatory requirements as well as company specifications and requirements. The individual in this position will ensure that service contracts are in place for all required third party support with the relevant KPI’s to ensure service needs from a safety, quality, and cost perspective are met. The individual in this position will also manage the data build of the asset maintenance and metrology programs and once in operation, manage the execution of on-going proactive maintenance/reactive repair and service/supply contracts and their associated activities across site. 

 

The individual in this position also leads the on-going support of all nonGMP/GMP facility systems and services across site in a manner to support an injury free workplace, a cost-effective operation, and holistic life cycle vantage of all associated assets/areas as well as drive operational excellence and continuous improvement focus activities across the site within the Facilities Engineering team.

 

The position will be based in Tonix’ New Bedford, MA facility once open and operational. Remote work arrangements will be in place until such time. 

  

Essential Duties

  • Support all design activities by reviewing all engineering designs from a maintenance, reliability, and operability perspective
  • Support the CQV team to ensure all facilities and systems are constructed and installed per the engineering design documents
  • Act as SME from design through to system handover for Facilities Equipment
  • Establish the necessary SOW’s and put in place facilities service/support contracts where required, e.g., gowning, security, landscaping, lifts, canteen services, janitorial services, AV support, pest control, etc.
  • Recruit, develop, and retain first class staff
  • Build and sustain employee engagement by creating a culture of optimal execution and an environment where individuals and teams excel and continuously improve
  • Plan and manage day-to-day facilities support to meet customer and manufacturing activities and plant shutdown schedules as well as ensure adherence with all regulatory/safety/GMP compliance in a cost-effective manner
  • Support Regulatory licensure activities, including vendor and agency preparations and inspections
  • Communicate operational status via written documentation and/or oral presentaions regularly to plant management at the appropriate level of detail
  • Support implementation of engineering capital projects within budgets and timelines that increase the performance and reliability of plant & production equipment
  • Ensure data build, of spares, calibrations program, and maintenance strategies, are fully documented on the site Maintenance system (CMMS)
  • Develop mechanisms for monitoring, trending, and reporting all equipment and systems performance
  • Facilitate and support staff and organization talent development
  • Ensure appropriate training of personnel on equipment, process, and facility safety procedures is maintained and up to date
  • 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, biological, mechanical, electrical engineering or related discipline or equivalent work experience required Ten (10) years’ experience in the biotech engineering/manufacturing environment
  • Five (5) years’ experience in a leadership position within facilities/maintenance or comparable function
  • Direct experience supporting manufacturing facilities and utility systems within an FDA/EMEA regulated environment
  • Knowledge of safety, GMP, and environmental regulatory requirements
  • Strong leadership skills
  • Solid background in contracts management and working with service providers
  • Fundamental knowledge of GMP equipment, utility, and cleanroom design/installations
  • Strong understanding of industry standards for commissioning, validation, and operation of facilities and utilities for cGMP manufacturing and GxP laboratories
  • Experience with a GMP facility startup and single-use technologies
  • 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 Facilities Manager 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, QA Compliance to effectively provide direction and leadership to the QA Compliance team. The individual in this position is responsible for providing strategic planning for QA Compliance, providing oversight and compliance to corporate standards and implementation and compliance to the Quality Management Systems within the Tonix facility. The individual will be overseeing the buildout of the QA Compliance department of a site specific GMP Manufacturing facility in New Bedford, Massachusetts opening in 2022. The individual in this position will have the unique opportunity to hire, train and supervise the QA Compliance staff.

The individual will also be responsible for aligning with the other Quality teams (QA Operations and QC) regarding accomplishing corporate goals/objectives and ensuring strategic planning of quality innovation.  They will provide the framework to operate with corporate standards and ensure the oversight and implementation of the Quality Management Systems within the Tonix facility. 

Furthermore, this individual will ensure that every manufacturing step is performed in compliance with cGMPs and internal controls that satisfy approved specifications.

The individual will work with the other QA and QC staff to ensure safety and compliance with FDA and other applicable global health authority requirements as appropriate.

This individual reports into the Head of Quality and is a member of the Quality management team at the facility.   

The position will be based in Tonix’ New Bedford, MA facility once open and operational. Remote work arrangements will be in place until such time.  

 

Essential Duties

  • Ensure that quality systems are applicable to operations, as well as build and maintain customized compliance standards as needed
  • Ensure the compliance and oversight of key Quality systems, including but not limited to risk management, change control, deviations, CAPA, training, self-inspection, and complaints
  • Provide and monitor quality metrics to ensure control of operations and drive continuous improvements.
  • Propose solutions in collaboration with the operations department as needed
  • Host the Site Quality council
  • Approve site risk register
  • Provide support to major and critical investigations
  • Assess the impact of changes on cGMP and regulations
  • Participate in regulatory inspections and clients’ audits
  • 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 Science or other related discipline or equivalent work experience required
  • A strong foundation in application of GMPSs in a drug substance or drug product manufacturing environment
  • Minimum 10 years’ combined experience in biotechnology/cell and gene therapy environment, covering QA and/or manufacturing
  • Strong GMP knowledge, covering FDA and Health Canada requirements
  • Proven Aseptic experience and training in cGMP large molecule industry strongly preferred
  • Demonstrated troubleshooting and problem-solving skills
  • Ability to work in a fast-paced and agile environment
  • Prior experience in quality leadership in the pharmaceutical industry is required
  • Experience with cell therapy and/or gene therapy is preferred
  • 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 humanresources@tonixpharma.com and include Manager, QA 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:

The Manager, QA Operations provides direction and leadership to the QA operations group.  The individual in this position also provides strategic planning for QA Operations, as well as oversight and compliance of manufacturing documentation (batch record review) and internal audits. The individual in this position will also be responsible for aligning with the other Quality teams regarding accomplishing corporate goals and objectives and ensuring strategic planning of quality innovation.

 

The individual in this position will oversee the buildout of the QA Operations department of a site specific GMP Manufacturing facility in New Bedford, MA opening in 2022. The individual in this position will have the unique opportunity to hire, train and supervise the QA Operations staff.

 

The individual in this position will work with the other QA and QC staff to ensure safety and compliance with FDA and other applicable global health authority requirements as appropriate.

 

This individual in this position reports into the Head of Quality and is a member of the Quality management team at the facility. 

 

Essential Duties:

  • Assist in the implementation of the overall quality strategy for the QA Operations group
  • Develop, direct, and maintain quality systems in support of Tonix manufacturing in a manner consistent with global quality systems, Tonix’s requirements and standards and current regulatory requirements (primarily US FDA and European requirements), and other requirements as needed; quality systems include but are not limited to audits and inspections, documentation, and records management.
  • Interface with site QA compliance / QC functions to support or develop appropriate interfaces with the site-based QA systems
  • Develop working relationships with other site functions for support of equipment, facility, utility, cleaning services and computer validation/qualification
  • Oversee all aspects of QA operations and act as first line of support for troubleshooting within the Tonix facility, including but not limited to executed batch record review, on the floor QA support, MODA data review, quality oversight for APSs
  • Build and maintain expertise in the QA Operations team, including development of staff
  • Apply aseptic manufacturing experience, including aseptic process validation, to ensure that manufacturing operations meet customer and regulatory expectations and requirements for aseptic manufacturing at all phases of product development
  • 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 science, engineering or other related discipline or equivalent work experience required
  • A strong foundation in application of GMPSs in a drug substance or drug product manufacturing environment is critical,
  • Ability to quickly assess facts and make the appropriate decisions
  • Advanced experience in a biopharmaceutical manufacturing environment and/or quality operations or quality systems working in a GMP environment is strongly preferred
  • Proven aseptic experience and training in cGMP large molecule industry is strongly preferred
  • Demonstrated troubleshooting and problem-solving skills
  • Prior experience in quality leadership in the pharmaceutical industry is strongly preferred
  • Experience with cell therapy and/or gene therapy preferred
  • 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, QA Operations 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 QC Manager will be responsible for the coordination and supervision of all biochemical, microbiological, environmental monitoring, analytical and chemical techniques with regards to the testing of raw materials, in-process, bulk release, drug product release, stability product samples and facility and personnel monitoring.  The individual will be overseeing the buildout of the QC laboratories of a site specific GMP Manufacturing facility in New Bedford, MA opening in 2022. The individual in this position will have the unique opportunity to hire, train and supervise the QC staff.

 

This position will work with the other Quality cross functional departments to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate.  This position 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.

 

Essential Duties:

  • Management of facility’s QC laboratories
  • Hire, train, and supervision of QC staff
  • Supervise the review of all laboratory data (both internal and external) and the closeout of laboratory investigations and deviations
  • Manage the scheduling of all QC testing, coordinating with the other departments delivering QC samples to ensure the timely delivery of results
  • Supervise all testing techniques and ensure full regulatory compliance to all laboratory functions
  • Ensure all QC personnel involved in testing and other laboratory functions are trained in basic and appropriate cGMP training principals and are receiving routine updates in cGMP information and training
  • Develop, author, and review appropriate change controls, deviations/investigations as well as QC test methods, specifications, and SOPs
  • Manage and supervise data and QC logbook(s) review
  • Interact with and support customer and regulatory authorities
  • Work interdepartmentally to enhance communications at all levels and ensure that work orders, preventative maintenance, compliance, and documentation issues are resolved in a timely manner
  • Evaluate vendors via vendor audits, comprehensive testing, and review of quality performance
  • Manage laboratory equipment qualification
  • Perform annual performance evaluations of all direct reports
  • Provide continued coaching and development of staff to help them meet both career and personal development goals, and to ensure a cohesive, productive, and highly motivated QC team
  • 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 or master’s degree in Biology, Chemistry, or other related discipline or equivalent work experience required
  • Ten (10) years of cGMP QC experience in biotechnology/large molecule expertise strongly preferred
  • Five (5) years in roles of increasing supervisory responsibility in a QC biopharmaceutical environment
  • Two (2) years’ experience supporting Phase 1-3 clinical trials manufacturing; commercial experience preferred
  • Exceptionally good understanding of QC principles and the different QC techniques used for testing
  • Demonstrated troubleshooting and problem-solving skills
  • Experience of analytical method transfer and/or method validation preferred
  • 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, QC 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 New Bedford MA in Q1, 2022. The position will be based in Tonix’ New Bedford, MA 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.Tonixpharma.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 equipment and processes.  The individual in this position will be responsible for the system ownership and project execution of process and utilities equipment.  Responsibilities include troubleshooting process equipment, 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 single-use technology designs 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/facility 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 process and performance problems
  • Provide on-call support for all active process equipment and manufacturing activities
  • Responsible for addressing safety related design/equipment issues
  • Own all aspects of process equipment and single-use technologies for GMP manufacturing
  • Revise single-use and process equipment designs to meet end-user's needs
  • Responsible for troubleshooting activities, equipment design, and specifications for equipment (including single-use technologies) 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 equivalent 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
  • Demonstrates the ability to solve problems of moderate scope
  • Proficiency with Microsoft Office products and ability to learn additional software applications, as needed
  • Hands-on expertise with bioprocess engineering and knowledge of disposable applications in a biologics process
  • Familiar with biotechnology single-use systems and stainless-steel 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 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 and any other characteristic protected by law.