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.
To expand our team, we are seeking three highly motivated Quality Control Scientists for the analytical laboratories in Hannover. These positions are part of the Quality Department.
Quality Control Scientist (m/f/d)
(full-time, permanent)
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
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.
You are a smart, proactive and solution-driven scientist with a hands-on attitude who is able to independently progress projects, prioritize tasks adequately and work against tight timelines. At the same time you maintain a high quality standard in your work, support the team and foster a sense of positivity. The team´s success is your success.
Language: English, German is highly beneficial.
Work Experience: Industrial work experience (biotechnology/biopharma) is highly appreciated 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.