Quality Control Scientist

Vor 5 Tagen

Hannover, Niedersachsen, Deutschland Glycothera Vollzeit 60.000 € - 90.000 € pro Jahr


Location

GlycoThera Pharmaceutical Services has been successfully providing analytical services for more than 20 years. Our clients are leading pharmaceutical companies specializing in biologics and biosimilars. Our comprehensive analytical service covers all phases of the product life cycle, from laboratory-scale development to market approval and batch release. Our strengths lie in method development, product characterization, validation and release and stability testing. We work according to the highest GMP standards and ICH guidelines to ensure that our customers meet regulatory requirements. With our many years of experience and expertise, we support our customers in meeting the highest quality standards and successfully bringing their products to market.

Key Responsibilities and Work assignments

Specifics of the Role:
  • Develop, optimize, and validate analytical methods for biologics and biosimilars using techniques such as HPLC, Capillary Electrophoresis (CE), and ELISA.
  • Perform and oversee analytical method transfer in compliance with GMP and ICH guidelines.
  • Perform and oversee QC release testing in compliance with GMP and ICH guidelines.
  • Ensure analytical methods meet regulatory requirements and are suitable for product release and stability testing.
  • Interpret and analyze data to identify trends and potential issues.
  • Contribute to the Quality Management System processes relevant for Quality Control (e.g., training, qualification, investigations).
  • Collaborate with cross-functional teams including R&D and Quality Assurance.
  • Troubleshoot complex analytical issues and implement effective corrective actions.
  • Prepare and review technical documentation, validation protocols, and reports


Your profile
  • Completed studies in Chemistry, Biology, Biochemistry, or a related scientific field.
  • 5+ years of experience in analytical method development and validation in the (bio-)pharmaceutical or biotechnology industry.
  • Proven hands-on experience with at least one of the following analytical techniques: HPLC, CE, ELISA.
  • 5+ years of experience in QC release testing under GMP conditions.
  • Good knowledge of Chromeleon is an advantage.
  • In-depth knowledge of regulatory requirements (GMP, ICH) for method validation and QC testing.
  • Strong analytical thinking and problem-solving skills.
  • Ability to thrive in a dynamic and interdisciplinary environment.
  • Excellent written and spoken English; German is a plus.


Why us?

Our Hannover-based laboratories with currently 30 employees offer an innovative, vibrant and multicultural environment that gives you the chance to bring in all your competencies, and together with a highly motivated team drive the change and develop personally. We believe in a culture of respect, trust, reliability and positivity.
 
Interested? Then please send your full application as a PDF including earliest start date and salary expectations via the application-button.
 
Become part of GlycoThera and grow with us

About us

GlycoThera Pharmaceutical Services is a leading global service provider for contract development and analytics for biotherapeutics at all stages of product life cycle. With our expertise in the development of biologics (recombinant proteins such as monoclonal antibodies, cytokines and hormones), manufacturing sciences, analytics, quality control and regulatory strategy we support a broad range of clients globally, from emerging biotech startups to leading global pharmaceutical companies.


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