Coriolis Pharma Research GmbH
82152 Planegg - Deutschland
Biowissenschaftler/in
Vollzeit
ab 04.11.2025
Beschreibung
### Purpose of your Job
As a Senior Scientist in GMP Analytical Services at Coriolis Pharma, you will leverage your scientific expertise to successfully guide complex customer projects within a GMP-regulated environment, ensuring that scientific objectives are met within quality and regulatory frameworks.
In this role, you will contribute to our state-of-the-art analytical services, applying advanced technologies to support the research and development of biopharmaceuticals and innovative drugs... weiter lesen
As a Senior Scientist in GMP Analytical Services at Coriolis Pharma, you will leverage your scientific expertise to successfully guide complex customer projects within a GMP-regulated environment, ensuring that scientific objectives are met within quality and regulatory frameworks.
In this role, you will contribute to our state-of-the-art analytical services, applying advanced technologies to support the research and development of biopharmaceuticals and innovative drugs... weiter lesen
### Purpose of your Job
As a Senior Scientist in GMP Analytical Services at Coriolis Pharma, you will leverage your scientific expertise to successfully guide complex customer projects within a GMP-regulated environment, ensuring that scientific objectives are met within quality and regulatory frameworks.
In this role, you will contribute to our state-of-the-art analytical services, applying advanced technologies to support the research and development of biopharmaceuticals and innovative drugs. You will be an integral part of our contract research organization—collaborating closely with and learning from our scientific operations teams—to enable our clients on their journey of developing cutting-edge therapeutics.
### Your Responsibility
Project Ownership & Scientific Expertise:
- Responsible—together with the project team—for the successful development and execution of analytical services for our customers worldwide.
- Act as subject matter expert, supporting client project acquisition and execution with your expertise to ensure high-quality services.
- Lead analytical strategy and actively contribute to experimental execution in alignment with SOPs, pharmacopoeias, and project-specific requirements.
- Apply laboratory techniques such as HPLC, particle analytics, and dynamic light scattering (DLS).
- Integrate scientific knowledge and a deep understanding of regulatory standards to address evolving business needs, including new areas and novel molecular modalities.
Quality & Regulatory Compliance:
- Ensure full adherence to QA and QC processes across all analytical activities.
- Manage deviations, CAPAs, change controls, and out-of-specification (OOS) results in compliance with regulatory guidelines.
Collaboration & Process Excellence:
- Collaborate closely with Coriolis teams (e.g., Business Development, Finance, Technical Support) to ensure seamless project execution.
- Contribute to cross-functional initiatives, driving both scientific and operational improvements.
- Support preparation of validation protocols, reports, and testing procedures.
Project Leadership & Knowledge Transfer:
- Serve as project leader for client projects, overseeing planning, method implementation, development, characterization, data evaluation, and reporting.
- Share your expertise with Coriolis team members and represent Coriolis’ scientific excellence within the broader scientific community.
### What you need to succeed
- University degree in analytical chemistry, pharmaceutical sciences, (bio)chemistry, or a related field; a PhD related to (U)HPLC method development or surfactant quantification is preferred
- Minimum 5 years of industry experience (with PhD in a relevant field) or 9 years (without PhD) in biopharmaceutical characterization by LC (RP, SEC, IEX) using UV, FLD, RI, or CAD detection
- Professional experience in a GMP-controlled environment with in-depth understanding of GMP regulations, quality management systems, and compliance standards
- Proven expertise in GMP analytical method development, validation, characterization, and technology transfer for drug product development of biopharmaceuticals
- Demonstrated project management experience with strong skills in resource management, multitasking, prioritization, and risk management
- Hands-on, proactive mindset with openness to new ideas and tasks; lead by example with a can-do attitude
- Team-oriented with strong motivational and interpersonal skills
- Excellent verbal and written communication skills in English
As a Senior Scientist in GMP Analytical Services at Coriolis Pharma, you will leverage your scientific expertise to successfully guide complex customer projects within a GMP-regulated environment, ensuring that scientific objectives are met within quality and regulatory frameworks.
In this role, you will contribute to our state-of-the-art analytical services, applying advanced technologies to support the research and development of biopharmaceuticals and innovative drugs. You will be an integral part of our contract research organization—collaborating closely with and learning from our scientific operations teams—to enable our clients on their journey of developing cutting-edge therapeutics.
### Your Responsibility
Project Ownership & Scientific Expertise:
- Responsible—together with the project team—for the successful development and execution of analytical services for our customers worldwide.
- Act as subject matter expert, supporting client project acquisition and execution with your expertise to ensure high-quality services.
- Lead analytical strategy and actively contribute to experimental execution in alignment with SOPs, pharmacopoeias, and project-specific requirements.
- Apply laboratory techniques such as HPLC, particle analytics, and dynamic light scattering (DLS).
- Integrate scientific knowledge and a deep understanding of regulatory standards to address evolving business needs, including new areas and novel molecular modalities.
Quality & Regulatory Compliance:
- Ensure full adherence to QA and QC processes across all analytical activities.
- Manage deviations, CAPAs, change controls, and out-of-specification (OOS) results in compliance with regulatory guidelines.
Collaboration & Process Excellence:
- Collaborate closely with Coriolis teams (e.g., Business Development, Finance, Technical Support) to ensure seamless project execution.
- Contribute to cross-functional initiatives, driving both scientific and operational improvements.
- Support preparation of validation protocols, reports, and testing procedures.
Project Leadership & Knowledge Transfer:
- Serve as project leader for client projects, overseeing planning, method implementation, development, characterization, data evaluation, and reporting.
- Share your expertise with Coriolis team members and represent Coriolis’ scientific excellence within the broader scientific community.
### What you need to succeed
- University degree in analytical chemistry, pharmaceutical sciences, (bio)chemistry, or a related field; a PhD related to (U)HPLC method development or surfactant quantification is preferred
- Minimum 5 years of industry experience (with PhD in a relevant field) or 9 years (without PhD) in biopharmaceutical characterization by LC (RP, SEC, IEX) using UV, FLD, RI, or CAD detection
- Professional experience in a GMP-controlled environment with in-depth understanding of GMP regulations, quality management systems, and compliance standards
- Proven expertise in GMP analytical method development, validation, characterization, and technology transfer for drug product development of biopharmaceuticals
- Demonstrated project management experience with strong skills in resource management, multitasking, prioritization, and risk management
- Hands-on, proactive mindset with openness to new ideas and tasks; lead by example with a can-do attitude
- Team-oriented with strong motivational and interpersonal skills
- Excellent verbal and written communication skills in English
Ref-Nr.: 7822925
Aktualisiert:
01.03.2026
Quelle: Bundesagentur für Arbeit
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Ob die Stelle noch verfügbar ist und weitere Informationen findest du direkt auf der Website der Bundesagentur für Arbeit. Bitte beachte: OPROMA ist nicht der Anbieter dieser Stelle und kann keine Auskünfte geben.
weitere Infos Rechtliche Hinweise zur Nutzung
Ob die Stelle noch verfügbar ist und weitere Informationen findest du direkt auf der Website der Bundesagentur für Arbeit. Bitte beachte: OPROMA ist nicht der Anbieter dieser Stelle und kann keine Auskünfte geben.
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