Job Description:
Process Chemist
Main Responsibilities:
1. Provide process chemistry support for existing and new processes.
2. Acquire and maintain a detailed knowledge and understanding of the chemistry of relevant processes, including mechanisms, development history, impurity formation, and control.
Key Tasks:
* Support laboratory troubleshooting and investigative activities.
* Lead/participate in thorough technical risk assessments for plant changes/product introduction.
* Prepare technical documentation to support manufacturing, e.g., Manufacturing Batch Records, laboratory SOPs, process steps, PQ protocols, PQ reports, technical training material, etc.
Techical Skills and Knowledge:
* Good interpersonal and organizational skills.
* Be flexible and able to adjust to business needs in a fast-paced CDMO environment.
* Good facilitation and presentation skills.
* Innovative, with potential for scientific leadership.
Quality and Compliance:
* Ensure all aspects of Product Quality Lifecycle Management are in place and actively maintained for the product.
* Perform duties in a compliant manner and behave in accordance with site SOPs, EHS standards, and guidelines, and relevant legal requirements.
* Ensure compliance with cGMP, FDA, and other quality regulatory agencies.