About the Role
This is an exciting opportunity for a seasoned QC Laboratory Manager to lead a team in a GMP laboratory environment. The ideal candidate will have experience with analytical method transfers, IPC technical transfer activities, and laboratory staff leadership.
Your Responsibilities:
* Develop and execute plans for analytical method transfers to ensure project timelines and objectives are met.
* Serve as the primary point of contact for all IPC technical transfer activities, coordinating with internal teams, manufacturing sites, and external partners.
* Lead 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 successful implementation of analytical methods.
* Generate and review technical documents, including IPC transfer protocols, reports, and SOPs, to support IPC method transfer activities.
Requirements:
* Bachelor's degree or equivalent in Biological Sciences, Chemistry, or other biotechnical science.
* 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.
* Ability to work effectively in a fast-paced matrixed organization.
* In-depth understanding of current regulatory requirements for IPC or QC, including analytical testing, data integrity, and cGMP laboratory equipment validation.
What We Offer:
* A dynamic and collaborative work environment.
* Opportunities for career growth and professional development.
* Competitive compensation and benefits package.
How to Apply:
Please submit your application, including your resume and cover letter, to [insert contact information].