Description

Management of bioassay projects, including bioassay development and validation, for release and stability testing of biologics following GMP requirements

• Full responsibility for managing customer bioassay projects for release and stability testing of biologics in the methodological field of cell based and immunological assays
• Responsible for method development, optimization, qualification/validation including reporting
• Communication with clients as primary contact
• Responsible for scientific and technical quality considering GMP requirements
• Planning and organization of project scheduling
• Review and approval of data including reporting of data according to GMP
• Monitoring and ensuring the GMP regulations and compliance
• Application of electronic tools like eQMS and LIMS
• Operation and support of analytical devices
• Supporting and organizing the practical work in the laboratory

Qualifications

• Successfully completed study (university or college of higher education) in biology, biochemistry, or any related subject, PhD is an advantage
• A minimum of 2-3 years practical experience in running cell based and/or immunological assays
• Proven track record in a GMP-regulated environment is an advantage
• High degree of self-motivation, commitment, and flexibility to provide pro-active interactions with our clients
• Independently and efficient way of working and willingness to take over management tasks
• Team player and leader
• High degree of analytical thinking and good organizational skills
• Very good user IT skills (MS Office, LIMS databases)
• Excellent oral and written communication skills in English and good skills in German

Additional Info

Company Description

SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.

Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. 

SGS Analytics Switzerland AG (formerly SYNLAB Analytics & Services Switzerland AG) offers a unique range of bioanalytical services for clinical development and drug development of pharmaceuticals and biologics. We provide a broad spectrum of analytical methods for PK analytics, immunogenicity, as well as for release and stability testing according to highest quality standards (GMP, GLP, GCP, ISO 17025). For more details, please follow this link and find more about our broad portfolio.