As a key member of our team, you will play a pivotal role in leading the planning and execution of analytical method transfers for In-Process Control (IPC) testing. Ensuring adherence to project timelines and objectives is crucial to your success.
About the Role:
* You will serve as the primary point of contact for all IPC technical transfer activities, fostering collaboration between internal analytical teams, manufacturing sites, and external partners.
* Collaborate with cross-functional teams to develop and validate IPC analytical methods, including protocol design, execution, and documentation.
* Conduct thorough risk assessments and troubleshooting activities to address IPC technical challenges and ensure the successful implementation of analytical methods.
* Develop and review technical documents, such as IPC transfer protocols, reports, and standard operating procedures (SOPs), to support IPC method transfer activities.
Requirements and Qualifications:
* Bachelor's degree in Biological Sciences, Chemistry, or other biotechnological science, or equivalent experience in a regulated industry.
* A minimum of 10 years of laboratory experience in a GMP laboratory environment.
* 5 years of analytical instrument validation/qualification experience is preferred.
* Demonstrated leadership skills, with experience managing laboratory staff in a GMP laboratory setting.
* Able to work effectively within a matrixed organization structure.
* In-depth understanding of current regulatory requirements for IPC or QC, including analytical testing data integrity and cGMP laboratory equipment validation.