Process Development Scientist Job Description

Review this Process Development Scientist job description for a reference when building your resume. Review the qualifications and requirements listed to get an understanding of what you need to include on your resume for what employers would look for in this field.

SUMMARY:

A Process Development Scientist is a specialized professional who plays a crucial role in developing and optimizing manufacturing processes, especially in industries such as pharmaceuticals, biotechnology, and chemical manufacturing. This position focuses on improving processes to enhance efficiency, yield, and product quality.

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FUNCTIONAL DUTIES:

1. Process Design and Optimization:
   • Design and develop manufacturing processes, specifying equipment, workflows, and production systems.
   • Continuously optimize processes to improve efficiency, reduce costs, and enhance product quality.
2. Scale-Up and Technology Transfer:
   • Scale up laboratory processes for industrial production, ensuring scalability and efficiency.
   • Transfer processes to manufacturing teams and facilitate a smooth transition.
3. Quality Control and Assurance:
   • Implement quality control measures to ensure products meet industry standards and specifications.
   • Design and maintain quality control systems to monitor product quality throughout production.
4. Equipment Selection and Maintenance:
   • Select and maintain machinery and equipment, ensuring they are efficient, reliable, and well-maintained.
   • Identify and address equipment issues to minimize downtime and production disruptions.
5. Process Validation:
   • Develop and execute process validation protocols to ensure consistent and reliable manufacturing.
   • Prepare validation reports and documentation.
6. Root Cause Analysis and Troubleshooting:
   • Investigate and resolve process issues and deviations by conducting root cause analysis.
   • Implement corrective and preventive actions to prevent reoccurrence.
7. Cross-Functional Collaboration:
   • Collaborate with cross-functional teams, including production, quality assurance, and regulatory affairs, to achieve project goals.
   • Communicate findings, project progress, and recommendations to team members and management.
8. Regulatory Compliance:
   • Ensure processes are compliant with industry regulations, such as FDA, GMP, and ISO standards.
   • Assist in preparing regulatory submissions and responding to inquiries from regulatory agencies.

REQUIREMENTS:

• Bachelor’s or Master’s degree in chemical engineering, pharmaceutical sciences, or a related field (Ph.D. may be preferred for more advanced roles).
• Proven experience in process development, scale-up, and process optimization in an industrial or manufacturing environment.
• Proficiency in process development software, simulation tools, and data analysis.
• Strong analytical and problem-solving skills.
• Excellent communication and teamwork skills to collaborate with cross-functional teams and project stakeholders.
• Attention to detail and a commitment to precision and quality.
• Knowledge of process development principles, industry standards, and manufacturing practices.
• Project management and budgeting skills.
• Ability to manage multiple projects and meet deadlines.
• Continuous learning and a willingness to adapt to new technologies and industry developments.

Note: This job description is intended to provide a general overview of the position and is not exhaustive. Duties and responsibilities may be adjusted to meet the specific needs of the manufacturing organization or industrial facility.

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