Manufacturing Process Specialist
We are seeking a highly motivated individual to join our team as a Manufacturing Process Specialist. As a key member of our organization, you will play a crucial role in ensuring the smooth execution of technology transfers, process optimization, and technical support.
Your primary responsibility will be to work collaboratively with internal partners to deliver technical transfer of our drug substance program. This includes providing manufacturing process support to resolve commercial production issues, authoring change control documents, managing process improvement projects, and conducting statistical analysis of process performance.
In addition, you will be responsible for technical transfer activities, including authorship and/or review of required GMP documentation and regulatory filings. You will have the opportunity to participate in all areas of tech ops, including supporting the execution of technology transfers and providing manufacturing process support.
* Key Responsibilities:
* Deliver Technical Transfer of Drug Substance Program: Work closely with internal partners to ensure seamless execution of technology transfers.
* Provide Manufacturing Process Support: Resolve commercial production issues and provide technical expertise to optimize manufacturing processes.
* Author Change Control Documents: Develop and maintain accurate records of changes made to manufacturing processes.
* Manage Process Improvement Projects: Identify areas for improvement and implement changes to increase efficiency and productivity.
* Conduct Statistical Analysis: Analyze data to inform decision-making and drive process improvements.