Job Overview:
The Quality Control Laboratory Manager position plays a vital role in overseeing the technical transfer of In-Process Control analytical methods and testing of Active Pharmaceutical Ingredients, intermediates, and cleaning samples.
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 science or equivalent experience in a regulated industry.
* Minimum of 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.
About the Role:
This is an exciting opportunity for a highly skilled and experienced Quality Control Laboratory Manager to join our team. As a key member of our organization, you will be responsible for leading a team of professionals in the development and validation of analytical methods, ensuring compliance with regulatory requirements and company standards.
What We Offer:
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and results-driven individual with a passion for quality control, we encourage you to apply for this challenging and rewarding role.