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.
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:
* Lead and manage drug product development or analytical projects under GMP.
* Communicate with the client from a technical perspective 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.
* Interpret scientific data and draw final conclusions; compile and present scientific data presentations as well as technical reports.
* 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.
* 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.
What you need to succeed
* A degree in pharmacy, (bio)chemistry, biotechnology, biophysics, or a related field (PhD preferred).
* Proven experience in managing large-scale projects and leading project teams.
* Ability to simplify and reduce complex tasks into key elements.
* Flexibility in working in different environments (GMP and R&D) as well as willingness to work across time zones.
* In-depth understanding of GMP regulations, quality management systems, and regulatory standards.
* Practical experience in a GMP-regulated laboratory environment, with expertise in laboratory techniques such as HPLC, UV-Vis spectroscopy, and particle size analysis is preferred.
* Strong background in analytical method development, validation, and qualification.
* Strong communication skills in English, both written and verbal, and the ability to collaborate effectively with cross-functional teams and clients.
Your Contact
Dominik Schwemmer
Senior Business Partner - Talent & Development
People, Organization & Culture Unit
Coriolis Pharma Research GmbH
Phone: +49 (0) 89 – 417760 - 0
Fraunhoferstraße 18 b, 82152 Martinsried
www.coriolis-pharma.com
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