Process Specialist Role
We are seeking a skilled Process Specialist to join our team in the pharmaceutical industry. This role involves collaborating with stakeholders to identify and execute transfer requirements for programs, including late-stage clinical and PPQ.
1. Collaborate with local and international groups to coordinate activities related to new drug substance manufacturing processes.
2. Support the development of process descriptions, models, and facility fits for continuous and fed-batch processes.
3. Work closely with stakeholders to deliver GMP documents such as risk assessments, change controls, and process design documents.
4. Improve local Tech Transfer procedures to streamline New Program Introduction ways of working while maintaining quality standards.
5. Assist in developing breakthrough business solutions to reduce effort and risk.
6. Ensure compliance with safety guidelines and work towards company goals.
7. Maintain the highest quality standards.
Requirements
1. Minimum 5 years of experience in the pharmaceutical or biotech industry.
2. Bachelor's degree in Biotechnology, Engineering, Chemistry, or related field.
3. Experience with project management and cross-functional teams.
4. Familiarity with upstream and/or downstream Unit Operations for mAb manufacturing.
5. Strong problem-solving skills and analytical capabilities.
6. Knowledge of quality management systems and compliance regulations.
7. Understanding of New Product Introduction principles.
8. Familiarity with automation systems in manufacturing processes.
9. Demonstrated experience in GMP-regulated environments.
10. Validation experience including documentation generation and execution.
11. Risk assessment and mitigation skills.
About the Role
This is an excellent opportunity for professionals looking to advance their careers in the pharmaceutical industry. If you have relevant experience and skills, we encourage you to apply for this challenging role.