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Last updated: 30+ days ago
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Scientist, Process Development

Scientist, Process Development

Tonix Pharmaceuticals IncNew Bedford, MA, US
Full-time
Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker : TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializin...Show moreLast updated: 30+ days ago
Staff Data Scientist

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Scientist, Process Development

Scientist, Process Development

Tonix Pharmaceuticals IncNew Bedford, MA, US
30+ days ago
Job type
  • Full-time
Job description

Job Description

Job Description

About Tonix

Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker : TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults.

Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA.

Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.

Please visit www.Tonixpharma.com for specifics on the pipeline.

  • All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication

Position Overview

As a Process Development Scientist, they will play a pivotal role in overseeing the collaboration and management of external development at Contract Development and Manufacturing Organizations (CDMOs).

This role supports process development and external manufacturing activities across different modalities within Tonix’s clinical development portfolio. The successful candidate will gain exposure to technical operations, regulatory documentation, and external development and manufacturing oversight, with opportunities for growth into advanced roles in development, manufacturing, and tech transfer.

Essential Duties

Personal Development

  • Perform review of CV and job description annually to ensure they reflect current job responsibilities and achievements.
  • Engage in continuous self-development by participating in internal and external training programs that enhance skills and knowledge relevant to job responsibilities.
  • Technical Support

  • Provide scientific expertise to CDMOs, assisting with process development, optimization, troubleshooting and scale-up.
  • Collaborate with CDMO research and development and product development teams to transfer new products or formulations.
  • Maintain knowledge and technical documentation throughout the product lifecycle.
  • Prepare and review technical documents, such as batch records, sampling plans, SOPs for processes and analytical methods, risk assessments, study protocols and reports, and sections for regulatory submissions.
  • Support process and product characterization, scale-up, process optimization, and process validation.
  • Utilize scientifically valid reasoning and statistical tools for data analysis to improve process understanding and identify key sources of variability and the root causes of product and process failures.
  • Support Technology Transfer Programs, employing a Quality by Design (QbD) approach to provide technical support to clinical and commercial manufacturing processes.
  • CDMO Relationship Management

  • Support the evaluation of potential contract manufacturers based on technical capabilities.
  • Foster a collaborative relationship with technical counterparts at CDMOs.
  • Actively assess and identify potential risks to program / product during external development activities and effectively communicate them to management.
  • Resolve any conflicts or issues promptly, ensuring effective communication and alignment.
  • Seek continuous improvement opportunities through feedback and collaboration.
  • Project Management

  • Support execution of project milestones, track progress, and address any deviations.
  • Mitigate risks related to process development delays or quality issues.
  • Quality Assurance and Compliance

  • Ensure compliance with quality standards are maintained during process development activities at contract development and manufacturing organizations.
  • Assist with troubleshooting processes, deviations, investigations, and CAPA implementation.
  • Participate in impact assessments for process / manufacturing changes related to clinical development programs.
  • Cross-Functional Collaboration

  • Collaborate with research, analytical development, regulatory, and quality control teams to streamline processes.
  • Engage with internal stakeholders to align program development expectations, goals and priorities.
  • Necessary Skills and Abilities

  • Knowledge of regulatory and industry guidelines (e.g., FDA, EMA, ICH, cGMP) related to pharmaceutical development.
  • Familiarity with quality management systems.
  • Excellent written and verbal communication skills.
  • Comfortable working independently with minimal supervision
  • Highly organized, results driven, problem solver, and detail oriented
  • Strong interpersonal skills, with the ability to work collaboratively across teams.
  • Educational Requirements

  • BS, MS, or Ph.D. in a relevant scientific field (e.g., chemistry, biology, engineering) with equivalent experience based on level of degree.
  • Experience Requirements

  • 3+ years of experience in a scientific role, pharmaceutical or biotechnology industry or academic experience preferred.
  • Previous experience with process development of small molecules or biologics preferred.
  • Recruitment & Staffing Agencies

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

    Compensation & Benefits

    Annualized base salary ranges from $70,000 to $120,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit.

    Tonix provides a comprehensive compensation and benefits package which includes :

  • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs
  • Pet Insurance
  • Retirement Savings 401k with company match and annual discretionary stock options
  • Generous Paid Time Off, Sick Time, & Paid Holidays
  • Career Development and Training
  • Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.