GMP Project Manager - Analytical Science (f/m/d)
Permanent employee, Full or part-time · Martinsried (BY)
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 complex customer projects in the GMP-regulated environment. You will oversee both the execution of laboratory operations and the strategic management of client projects, 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:
- Project Management: Oversee and manage client projects and project teams, ensuring that all project milestones, timelines, and budgets are met. Coordinate with cross-functional teams to ensure efficient and timely project execution.
- Client Relationship Management: Foster strong client relationships by ensuring clear communication, setting expectations, and addressing concerns to ensure client satisfaction and the success of their projects.
- Support development: Supervise, instruct and support on-boarding of new team members. Ensure efficient knowledge transfer within project teams.
- Scientific Oversight: Oversee and actively contribute to the execution of experiments following SOPs, pharmacopoeias, and project-specific requirements. Lead the analytical strategy, utilizing laboratory techniques.
- Data Analysis & Reporting: Analyze experimental data, interpret results, and prepare comprehensive reports for both internal teams and clients. Collaborate closely with project stakeholders to assess progress and adapt strategies as necessary.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.
- Cross-Functional Collaboration: Drive and contribute to cross-functional teams, managing resources, ensuring smooth project execution, and identifying opportunities for improvement. Assist in the preparation of validation protocols, reports, and testing procedures.
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 of project teams
- Ability to simplify and reduce complex tasks into the 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.
Why to join Coriolis?
Let’s formulate innovation together…
Our success & development is created by the people working together @Coriolis.
We put People first! That’s why we have a growth mindset, and value personality, collaboration and community to create an empowering and inspiring working space with focus on quality and clients.
We would like to grow together with you!
Let’s continue building and creating the future now, join our team of currently around 200 employees. In a highly motivated and interdisciplinary team, we provide you with a great chance to increase your experience.
We offer an attractive work space at the Martinsried site. Let’s make a difference together!
Coriolis Pharma is an equal opportunity employer and welcomes applications from all qualified individuals regardless of ethnicity, gender, citizenship or gender identity, color, disability, religion/belief, romantic orientation, marital status, age or individual preferencies. Different backgrounds, experiences and ideas push us further and raise the bar.
Thank you for your interest! We look forward to receiving your application documents.
Please use the apply button 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.
We are looking forward to your application!
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
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.