Process Development Scientist

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.

• 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.

• 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.

• 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.

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

• 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.

• 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.

• 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.

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

• 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.

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.

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.

• 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