(Technical) Project Manager (f/m/d) - GMP

at  Coriolis Pharma Research GmbH

YOUR RESPONSIBILITY

As a GMP Project Manager, you will manage the execution of customer projects, coordinate laboratory activities, and ensure compliance with project requirements. Your responsibilities will include:

• Take over the responsibility to lead and manage drug product development or Analytical projects under GMP
• Take over the lead in the communication with the client from technical end and coordinate internally with other project team members and involved units at Coriolis
• Ensure that relevant resources are embedded into the project and that project-related decisions are based on state-of-the-art scientific principles
• Perform experimental project planning, coordination, resource management, and execution (supported by project team members)
• Ensure that project deliverables, i.e. experimental plans, experimental data, data presentations and reports are prepared timely and according to the required quality standards
• Take over the responsibility for interpretation of scientific data and the drawing of final conclusions; compile and present scientific data presentations as well as technical reports
• Equipment & Compliance Management: Oversee the qualification, maintenance, and proper functioning of analytical equipment, ensuring compliance with GMP standards. Manage equipment calibration, validation, and maintenance activities, ensuring that all systems meet regulatory requirements.
• Quality Assurance & Regulatory Compliance: Lead efforts to ensure full adherence to QA and QC processes. Manage deviations, CAPAs, change controls, and out-of-specification (OOS) results, ensuring that all actions align with regulatory guidelines.

ABOUT US

Coriolis Pharma, is a globally operating service provider and one of the world leaders in formulation research and development of (bio)pharmaceutical drugs and vaccines.
We revolutionize the development process of biopharmaceutical drugs by integrating innovative digital formulation approaches from drug development to commercial products.
As a people and team-oriented company with an interdisciplinary team of highly skilled scientists and an expert scientific advisory board, we provide cutting-edge services and tailor-made solutions for our clients.
Our company culture is based on diversity, teamwork and open and appreciative communication. That’s why wonderful people from over 35 nations around the world work together successfully at Coriolis.
What motivates us? Our motivation is to enable the development of innovative drugs by performing outstanding biopharmaceutical research to improve the quality of life for humankind.

PURPOSE OF YOUR JOB

At Coriolis Pharma, we are committed to ensuring the successful production and commercialization of our clients’ biopharmaceutical products. As a GMP Project Manager, you will leverage your scientific expertise and project leadership skills to manage operative customer projects in the GMP-regulated environment. You will oversee the execution of laboratory operations and will be ensuring that scientific objectives are met within quality and regulatory frameworks.

PLEASE USE OUR CAREER PORTAL EXCLUSIVELY FOR THIS PURPOSE.

We would like to support you from the very beginning to shape your development possibilities here at Coriolis.
For questions or further information, please visit our website or contact us directly.

As a GMP Project Manager, you will manage the execution of customer projects, coordinate laboratory activities, and ensure compliance with project requirements. Your responsibilities will include:

• Take over the responsibility to lead and manage drug product development or Analytical projects under GMP
• Take over the lead in the communication with the client from technical end and coordinate internally with other project team members and involved units at Coriolis
• Ensure that relevant resources are embedded into the project and that project-related decisions are based on state-of-the-art scientific principles
• Perform experimental project planning, coordination, resource management, and execution (supported by project team members)
• Ensure that project deliverables, i.e. experimental plans, experimental data, data presentations and reports are prepared timely and according to the required quality standards
• Take over the responsibility for interpretation of scientific data and the drawing of final conclusions; compile and present scientific data presentations as well as technical reports
• Equipment & Compliance Management: Oversee the qualification, maintenance, and proper functioning of analytical equipment, ensuring compliance with GMP standards. Manage equipment calibration, validation, and maintenance activities, ensuring that all systems meet regulatory requirements.
• Quality Assurance & Regulatory Compliance: Lead efforts to ensure full adherence to QA and QC processes. Manage deviations, CAPAs, change controls, and out-of-specification (OOS) results, ensuring that all actions align with regulatory guidelines