Job Title: QC Lab Manager
The successful candidate will lead a team of analytical professionals responsible for the technical transfer and execution of In-Process Control (IPC) laboratory testing. This includes overseeing the day-to-day operations of the IPC laboratory, ensuring compliance with regulatory requirements and company policies while driving continuous improvement initiatives.
Key Responsibilities:
* Lead the planning and execution of analytical method transfers for IPC testing, ensuring adherence to project timelines and objectives.
* Serve as the primary point of contact for all IPC technical transfer activities, liaising between internal analytical teams, manufacturing sites, and external partners.
* Coordinate the development and validation of IPC analytical methods, including protocol design, execution, and documentation.
* Conduct risk assessments and troubleshooting activities to address IPC technical challenges and ensure the successful implementation of analytical methods.
* Generate and review technical documents, including IPC transfer protocols, reports, and standard operating procedures (SOPs), to support IPC method transfer activities.
Requirements:
* Bachelor's degree or equivalent in Biological Sciences, Chemistry, or other biotechnical sciences.
* Minimum 10 years of laboratory experience in a GMP laboratory environment.
* 5 years of analytical instrument validation/qualification experience preferable.
* Proven leadership of laboratory staff and experience in a GMP laboratory.
* Proven ability to work in a matrixed organization.
* In-depth understanding of current regulatory requirements for IPC or QC, including analytical testing, data integrity, and cGMP laboratory equipment validation.